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CHARLES H. BANOV, M.D. National Allergy, Asthma & Urticaria Centers of Charleston, P.A. 1879 Savage Rd. 9165 University Blvd Charleston, South Carolina 29407 Charleston, SC 29406 Research Phone (843)820-1036 Research Phone (843)852-4852 Research Fax (843)820-1300 Research Fax (843)852-0950 Practice Phone (843)797-8162 Practice Phone (843)573-9373 Practice Fax (843)797-8372 Practice Fax (843)573-9970 EDUCATION 1951-1955 M.D. Degree: Medical College of South Carolina TRAINING 1955-1956 Internship: Milwaukee County Hospital, Milwaukee, Wisconsin 1958-1960 Residency: Charity Hospital of Louisiana, New Orleans, Louisiana 1960-1961 Residency: Massachusetts General Hospital, Harvard Medical School Boston, Massachusetts 1956-1958 Military Service: Active Duty U.S. Navy, Lt. Commander 2006 - Present Reserve Medical Officer: Israel Defense Force 1948-1951 Undergraduate Education: B.S. Degree, Emory University MEDICAL EXPERIENCE 7/61- Present National Allergy, Asthma and Urticaria Centers of Charleston, P.A. Charleston, South Carolina 10/99 -1/04 Principal Investigator – Radiant Research, Charleston, South Carolina Consultant to Department of Health, Education, Welfare – Social Security Administration CERTIFICATION AND LICENSURE Licensure: State of South Carolina #3835 Certification: 1964 American Board of Internal Medicine 1972, 1977 American Board of Allergy and Immunology PROFESSIONAL AND ACADEMIC APPOINTMENTS 1988-Present Clinical Professor of Medicine Medical University of South Carolina Charleston, South Carolina 1988 - Present Clinical Professor of Microbiology and Immunology Medical University of South Carolina Charleston, South Carolina

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Page 1: Charles H. Banov, M.D. CV - officeupstairsthebook.comofficeupstairsthebook.com/documents/Charles-Banov-CV.pdf · A Randomized, Double-Blind, Parallel Group Comparison of Inhaled XXX

CHARLES H. BANOV, M.D.

National Allergy, Asthma & Urticaria Centers of Charleston, P.A.1879 Savage Rd. 9165 University BlvdCharleston, South Carolina 29407 Charleston, SC 29406

Research Phone (843)820-1036 Research Phone (843)852-4852Research Fax (843)820-1300 Research Fax (843)852-0950Practice Phone (843)797-8162 Practice Phone (843)573-9373Practice Fax (843)797-8372 Practice Fax (843)573-9970

EDUCATION1951-1955 M.D. Degree: Medical College of South Carolina

TRAINING1955-1956 Internship: Milwaukee County Hospital, Milwaukee, Wisconsin1958-1960 Residency: Charity Hospital of Louisiana, New Orleans, Louisiana1960-1961 Residency: Massachusetts General Hospital, Harvard Medical School

Boston, Massachusetts1956-1958 Military Service: Active Duty U.S. Navy, Lt. Commander2006 - Present Reserve Medical Officer: Israel Defense Force

1948-1951 Undergraduate Education: B.S. Degree, Emory University

MEDICAL EXPERIENCE7/61- Present National Allergy, Asthma and Urticaria Centers of Charleston, P.A. Charleston, South

Carolina

10/99 -1/04 Principal Investigator – Radiant Research, Charleston, South Carolina

Consultant to Department of Health, Education, Welfare – Social Security Administration

CERTIFICATION AND LICENSURELicensure: State of South Carolina #3835

Certification:1964 American Board of Internal Medicine1972, 1977 American Board of Allergy and Immunology

PROFESSIONAL AND ACADEMIC APPOINTMENTS

1988-Present Clinical Professor of MedicineMedical University of South CarolinaCharleston, South Carolina

1988 - Present Clinical Professor of Microbiology and ImmunologyMedical University of South CarolinaCharleston, South Carolina

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1961-1988 Associate Professor of MedicineMedical University of South CarolinaCharleston, South Carolina

1961 - 1988 Associate Professor of Microbiology and ImmunologyMedical University of South CarolinaCharleston, South Carolina

HOSPITAL AFFILIATIONSBon Secours-St. Francis Hospital, Charleston, South CarolinaEast Cooper Regional Medical Center, Mt. Pleasant, South CarolinaRoper Hospital, Charleston, South CarolinaRoper Hospital North, North Charleston, South CarolinaTrident Medical Center, North Charleston, South Carolina

INSTITUTIONAL AFFILIATIONSFellow – American College of AllergyFellow – American Academy of AllergyFellow – American College of PhysiciansFellow – American College of Chest PhysiciansPast President – South Carolina Society for Autistic ChildrenPast Vice President – Southeastern Allergy AssociationFellow – American Association of Certified AllergistPast President – American College of AllergistsBoard of Regents – American College of AllergistsPast President – South Carolina Society of Allergy and ImmunologyElected to Board of Joint Council of Allergy and ImmunologyAllergy-Immunology Section of MKSAP VI of the American College of Physicians (Patient Management Section)Past Treasurer – Joint Council of Allergy and ImmunologyMember of the National Board of Trustees of the Asthma and Allergy Foundation of AmericaBoard of Governors of the American Association of Certified AllergistsMember of the National Board of Trustees of the American Physicians Fellowship, Inc.President – INTER ASMA

AWARDS AND PRIZESFellow Distinguished Award – American College of Allergists, 1987Physician’s Recognition Award – American Medical AssociationAlpha Omega Alpha Honorary Medical Society

PROFESSIONAL ORGANIZATIONS:

EDITORIALSHIPS: Editorial Boards:

1987-Present Journal of Immunology and Allergy Practice1986-1991 Annals of Allergy1983-1987 New England & Regional Proceedings1995-Present Journal of Investigational Allergology & Immunology

LECTURESHIPS: International:1985 Venezuela1986 Peru, Columbia, Brazil1987 Argentina1988 Costa Rica1989 Mexico

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1991 Japan (International Allergology Association)Portugal (Interasma)Israel (Mediterranean Pollen Society)

1992 France (European Allergy Society)Equador

1993 Thailand (First Asian Allergy Conference)Venezuela (Latinoamerican Allergy Association)Israel (Interasma)

1994 Sweden International Allergy Association1995 Spain (European Allergy Association)

Poland (Interasma)Mexico (Mexican Allergy Society)

1996 Argentina (Sociedad Latinoamerican De Alergia)France (Interasma)Hungary (European Academy of Allergology)Canary Islands (Western European Intersama)

PUBLICATIONS:

Banov, C.H., “Long-Term Anticoagulation in Sickle Cell Disease.” New England Journal of Medicine, 269:182-186, July 25, 1963.Banov, C.H., “Paroxysmal Cold Hemoglobinuria.” Journal of the American Medical Association, 174: 1974-1975, December 10, 1969. Copyright 1960 by American Medical Association.Banov, C.H., “Which Drugs for which Allergic Reactions?” Consultant – July-August, 1969.Banov, C.H., “Insect Allergic Emergencies.” Journal of the South Carolina Medical Association, 9: 386-391,September, 1971.Banov, C.H., “When You Suspect a Drug Allergy.” The Journal of Practical Family Medicine – Patient Care,pp. 91-104, October 1, 1973.Banov, C.H., “Individualizing Therapy for your Asthmatic.” Journal of Practical Family Medicine – PatientCare, pp. 112-147, November 1, 1973.Banov, C.H., “The Treatment of Acute Bronchial Asthma in the Adult.” Journal of the South CarolinaMedical Association, pp. 424-425, November, 1973.Banov, C.H., “Treatment of Chronic Bronchial Asthma in the Adult.” Journal of the South Carolina MedicalAssociation, pp.426-430, November, 1973.Banov, C.H., Chapter on “Therapy of Bronchial Asthma in Adult.” Current Therapy of Allergy, Ed. MedicalExam. Publishing Co., 1st and 2nd ed., 1975 & 1977, pp. 178-184.Banov, C.H., “Poison Plant Allergy – How to Tell, What to Do.” The Practical Journal for PrimaryPhysicians – Patient Care, pp. 29-31, June 30, 1979.Banov, C.H., “Insect Allergy Revisited.” Journal of the South Carolina Medical Association, 75: 447-448,October, 1979.Banov, C.H., “Caring for the Patient with Asthma.” The Practical Journal for Primary Physicians – PatientCare, pp. 25-131, August 15, 1981.Banov, C.H., “When Environment Exacerbates Asthma.” The Practical Journal for Primary Physicians –Patient Care, pp. 63-98, October 30, 1981.Banov, C.H., “Bee Sting – Helping Reactors Cope.” The Practical Journal for Primary Physicians – PatientCare, pp. 40-51, June 30, 1979.Banov, C.H., “When your Patient’s Asthma is Mild” and “When Asthma Causes Moderate Trouble.” ThePractical Journal for Primary Physicians – Patient Care, pp. 115-186, November 15, 1981.Banov, C.H., “When your Patient’s Asthma is Severe.” The Practical Journal for Primary Physicians – PatientCare, pp. 59-93, November 30, 1981.Banov, C.H., “How to Intervene in Status Asthmaticus” and “How to Intervene in Respiratory Failure.” ThePractical Journal for Primary Physicians – Patient Care, pp. 105-147, January 30, 1982.Banov, C.H., “Set up for Office Allergic Emergencies.” The Practical Journal for Primary Physicians –Patient Care, pp. 155-170, February 28, 1989.Banov, C.H., Contributor, Allergy Section, MKSAP-VI, published by American College of Physicians, 1983.Salvaggio, J.E., Banov, C.H., Bloch, K., Fink, J.N., Grant, A.J., Stechschulte, D.J., Zweiman, B., “Allergy andImmunology: An Annotated Bibliography of Recent Literature ” Annals of Internal Medicine 97: 791-798

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Banov, C.H., Contributor, “Primer of Allergic and Immunological Diseases.” JAMA, 248(20): 2579-2772,1982.Banov, C.H., “Outpatient Allergic Emergencies.” CUTIS, Vol. 3 33, # 2, 1984.Banov, C.H., Epstein, John H., Grayson, Leonard D., “Unraveling Clues to the Cause of Itching.” PatientCare, 18(14): 18-60, August 15, 1984.Banov, C.H., Epstein, J.H., Grayson, L.D., “Doctor, I can’t Stand this Itching!” L.H. Labson, ed., PatientCare, 18: 89-121, October 15, 1984.Banov, C.H., Editorial, “Allergic Problems in the School Setting.” Annals of Allergy, 86, January, 1986.Banov, C.H., President’s Address, “Optimistic Outlook and Future!!!” Annals of Allergy, 56, April, 1986.Banov, C.H., et al, “Impact of Fire Ant Sting Morbidity in South Carolina, 1986.” The Journal of the SouthCarolina Medical Association, 83(5), 249-252, May, 1987.Banov, C.H., Estado Unidos, “Anafilaxia. Que hay de neuvo?” Topics En Alergic E. Immunologia Clinica,Editor, Samuel Malka, 145-152, 1987.Banov, C.H., Estados Unidos, “Sindrome de idiosincrasia a la aspirina y a la tartrazina.” Topicos En AlergiaE. Immunologia Clinica, Editor, Samuel Malka, 331-337, 1987.Banov, C.H., Estados Unidos, “Control de calidad de la immunoterapia e un ambiente de pacientesambulatorios.” Topicos En Alergic E. Immunologia Clinica, Editor, Samuel Malka, 347-351, 1987.Banov, C.H., “Efficacy of Loratadine 10 mg once Daily Compared with Terfenadine 120 mg Once Daily.”Michael Kaliner, Editor, Management of Allergy in the 1990’s. Proceedings of a Special Symposium held atthe XIII International Congress of Allergology and Clinical Immunology in Montreaux, Switzerland, October20, 1988, Hans Huber publishers.Banov, C.H., “Comparative Efficacy of Once Daily Loratadine Versus Terfenadine in the Treatment ofAllergic Rhinitis.” Journal of Internal Medicine Res., 17: 150-156, 1989.Banov, C.H., et al, “SCH 434: A New Antihistamine/Decongestant for Seasonal Allergic Rhinitis.” TheJournal of Allergy and Clinical Immunology, Vol. 83, No. 6, June, 1989.Banov, C.H., “When Pruritus is a Diagnostic Puzzle.” Patient Care, Vol. 23, No. 15, September, 1989.Banov, C.H., Epstein, J.H., Grayson, L.D., “Treating the Itch that Persists.” Patient Care, Vol. 23, No. 16,October, 1989.Banov, C.H., “Anatomy and Physiology of the Lower and Upper Airway.” The Journal of Allergy andClinical Immunology, Vol. 84, No. 6, Part 2, December, 1989.Banov, C.H., “An Allergist’s View of Medical Planning for Natural Disasters.” The Journal of Allergy andClinical Immunology, Vol. 86, No. 1, July, 1990.Banov, C.H., “Clinical Ecology: Concept and Treatment.” Clinical Advances in the Treatment of AllergicDisorders, Vol. 1, No. 4, September, 1990.Banov, C.H., “Anatomy, Physiology, Standardization of Extracts and Stability of Extracts.” LiteratureReview for ABAI Exam, Vol. 67, August, 1991.Banov, C.H., “Treatment of Perennial Allergic Rhinitis with Fluticasone Propionate.” Poster Session, 47th

Annual Meeting of American College of Allergy and Immunology, 1990.Banov, C.H., “Revue actuelle de l’anaphylaxie et sa correlation avec l’asthme.” Allergie & Immunologie, Vol.XXIII, No. 10, Decembre, 1991.Banov, C.H., Epstein, J.H., Grayson, L.D., “When an Itch Persists.” Patient Care, Vol. 26, No. 5, March 15,1992.Banov, C.H., “Perennial Rhinitis in a Middle-Aged Businessman.” CCAD, Vol. 2, No. 1, Spring, 1993.P. Chervinsky, M.D., C.H. Banov, M.D., J. Georgitis, M.D., P. Boggs, M.D., R. Vande Stouwe, M.D., S.Grenstein, M.D., “Once Daily Loratadine Versus Astemizole Once Daily.” Annals of Allergy, Vol. 73, No. 2,August, 1994.Banov, C.H., “Once Daily Intranasal Fluticasone Propionate is Effective for Perennial Allergic Rhinitis.”Annals of Allergy, 73(3): 240-246, September, 1994.Banov, C.H., M.D., “Pregnancy and Asthma.” In: Neffen, H.E., M.D. and Baena, C.E., M.D., Asthma,Allergy and Respiratory Medicine. Proceedings of the Interasthma ’95 Congress, Buenos Aires, December,1995, pp. 187-188.C.H. Banov, M.D., William S. Silvers, M.D., Andrew W. Green, M.D., Julius H. Van Bavel, M.D., John A.Winder, M.D., Gary Feiss, M.S., Brandon Simpson, John A. Furst, and Joseph A. Smith, M.D., “Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Triamcinolone Acetonide Aerosol NasalInhaler in Pediatric Patients with Seasonal Allergic Rhinitis.” Clinical Therapeutics, Vol. 18, No. 2, 1996.Banov, C.H., M.D., Ring, J., M.D., “Clinical Ecology Syndrome.” ACI INT, 8: 158-60, 1996.Finn, A.F., M.D., Levy, A., M.D., Banov, C.H., M.D., “Autoimmune Thyroid Antibodies and Thyroid

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Banov, C.H., MD, “An allergist’s role in a natural disaster.” Annals of Allergy, Asthma & Immunology,96:628-630, April 2006.

PERSONALBirth Date: August 15, 1930Address: Charleston, South CarolinaPhone: (843) 852-4852Fax: (843) 852-0950

CLINICAL RESEARCH EXPERIENCE

1. A Phase II/III, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy, Safety andDose Response Study of XXX (XXX) XXX Inhalation Aerosol 225 mcg, 450 mcg and 900 mcgAdministered Once Daily for 12 Weeks in the Treatment of Mild Persistent and Moderate PersistentAsthma in 800 Adolescents and Adults.

2. A Multicenter, Double-Blind, Randomized Study Comparing the Clinical Effect of ConcomitantXXX+XXX with XXX, XXX and Inhaled XXX in Patients with Chronic Asthma.

3. A Double-Blind, Randomized, Placebo-Controlled Study of XXX (XXX) in the Treatment ofInfluenza Infection.

4. Placebo-Controlled Efficacy and Safety Study of XXX in the Treatment of Asthma in PatientsPreviously Maintained on Inhaled Beta-Agonists Alone.

5. A Randomized, Double-Blind, Parallel Group Comparison of Inhaled XXX (42 mcg BID) with OralXXX (20 mg BID) in Subjects with Mild to Moderate Asthma.

6. A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group ComparativeStudy of Inhaled XXX (88 MCG BID) Versus XXX (20 MG BID) in Subjects who are CurrentlyReceiving Beta Agonists Alone.

7. A Multicenter, Double-Blind, Parallel-Group Comparison of the Safety and Efficacy of XXX 300 mgTwice Daily with Placebo in Patients with Asthma.

8. Efficacy and Safety of 800 mcg or 400 mcg of XXX Nasal Spray or Placebo in the Treatment of AcuteEpisodes of Sinusitis.

9. A Randomized, Open-Label, Cross-Over Study Comparing the Parent/Guardian Preference for XXXTablets or XXX Aerosol (XXX) Treatment in their Children Ages 6 to 11 with Chronic Asthma.

10. A Randomized, Double-Blind, Double-Dummy, Six-Way Crossover Comparative Clinical Trial ofSingle Doses of XXX in XXX Propellant with Different Water Content Via the XXX Versus Placebo(XXX) in Adult Subjects with Asthma.

11. A Long-Term, Open-Label Safety Study of XXX 20 mg in Patients with Perennial Allergic Rhinitis.

12. A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Study Comparing the Efficacyand Safety of Four Dosage Strengths of XXX (20, 60, 120, and 240 mg BID) in the Treatment ofChronic Idiopathic Urticaria.

13. A Dose-Ranging, Safety and Efficacy Trial with XXX (XXX™) in the Treatment of Pediatric Subjects with Mild-to-Moderate Asthma.

14. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Ability of XXX to Allow Tapering of Inhaled Corticosteroids in Asthmatic Patients.

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15. One-Year, Evaluator-Blind, Safety Study of XXX Nasal Spray vs. XXX in Children (Ages 6-11) withPerennial Rhinitis.

16. Prospective, Randomized, Double-Blind Comparison of the Safety and Efficacy of XXX, 400 mg PO qdfor 7 Days vs. XXX 250 mg BID for 10 Days for the Treatment of Patients with Acute BacterialMaxillary Sinusitis.

17. Placebo-Controlled Efficacy and Safety Study with Long-Term Safety Evaluation of XXX Dry Powder inthe Treatment of Asthma in Subjects Previously Maintained on Inhaled Beta-Agonists.

18. Placebo-Controlled, Dose Ranging Study of XXX Dry Powder Compared to XXX (XXX™) in theTreatment of Asthma in Subjects Previously Maintained on Inhaled Corticosteroids.

19. Multicenter, Double-Blind, Comparative Study of the Efficacy and Safety of XXX vs. XXX and Placeboin the Treatment of Chronic Idiopathic Urticaria.

20. Efficacy and Safety of XXX Nasal Spray in the Treatment of Acute Episodes and Recurrences ofSinusitis.

21. Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Onset of Efficacy (Effect onPulmonary Function) of Oral XXX, 300 mg BID and Inhaled XXX™ (84 mcg QID) in Patients withMild-to-Moderate Asthma.

22. Randomized, Double-Blind, Parallel Group, Comparative Trial Evaluating XXX (220 mcg BID), XXX(600 mcg BID), and XXX (88 mcg BID) in Combination with XXX (42 mcg BID), each Delivered viaa Metered Dose Inhaler, in Subjects with Asthma who Remain Symptomatic Despite Receiving InhaledCorticosteroids.

23. XXX and XXX (440 mg BID) Alone and in Combination vs. Placebo in Patients with Seasonal AllergicRhinitis and Headache.

24. Multicenter, Double-Blind, Crossover Study Comparing the Clinical Effect of Combination XXX/XXXto XXX in Patients with Chronic Asthma.

25. A Double-Blind, Placebo-Controlled, Multi-Dose, Multicenter Pilot Trial to Assess the Efficacy, Safety,Tolerability, Pharmacokinetics, and Biologic Activity of XXX in Patients with Allergic Asthma.

26. Dose-Ranging Study of XXX Nasal Spray in the Treatment of Children (Ages 6-11) with SeasonalAllergic Rhinitis.

27. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy ofXXX (XXX™) and XXX in Subjects with Seasonal Allergic Rhinitis.

28. Dose Response Comparison of XXX with XXX in Patients with Asthma.

29. Comparison of XXX vs. XXX in Seasonal Allergic Rhinitis.

30. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Determine the Effects ofXXX (XXX™) on Subjects with both Asthma and Seasonal Allergic Rhinitis.

31. A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing XXX to Placebo in 6- to14-Year Old Patients with Chronic Asthma.

32. A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of XXX AqueousNasal Spray vs. Placebo Followed by a One-Year, Open-Label Safety Extension in Subjects withPerennial Non-Allergic Rhinitis.

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33. A Twelve-Month, Open-Label Trial to Assess the Long-Term Safety of XXX 50 mcg BID via theXXX™ in Adolescent and Adult Subjects with Asthma.

34. A Study of the Effects of XXX on Nasal Stuffiness in Seasonal Allergic Rhinitis.

35. A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Comparison of the Safety and Efficacyof Oral Twice Daily Administration of XXX with Inhaled XXX in Patients with Mild-to-ModerateAsthma.

36. A Comparative Study of the Safety, Efficacy, and Subject Preference of XXX vs. XXX and XXXAqueous Nasal Spray in the Treatment of Seasonal Allergic Rhinitis.

A Randomized, Open-Label Comparison of XXX™ (XXX) Aqua Pump Spray vs. XXX™ (XXX) in. the Treatment of Children with Perennial Allergic Rhinitis

37. A Randomized, Open-Label Comparison of XXX™ (XXX) Aqua Pump Spray vs. XXX™ AQ (XXX) inthe Treatment of Adults with Perennial Allergic Rhinitis.

38. A Stratified, Randomized, Double-Blind, Parallel-Group Trial Assessing the Efficacy and Safety of XXXvia the Multidose Powder Inhaler 50 mcg BID, 100 mcg QD, and Placebo in Subjects Aged 4 to 11Years with Chronic Asthma.

39. A Stratified, Randomized, Double-Blind, Parallel-Group, Comparative Trial of Inhaled XXX via theMulti-Dose Powder Inhaler 100 mcg QD, 200 mcg QD, 500 mcg QD, and Placebo in Adolescent andAdult Subjects with Chronic Asthma.

40. Safety and Efficacy Study of XXX vs. XXX Tablets vs. Placebo in the Treatment of Patients withSeasonal Allergic Rhinitis.

41. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate theAbility of XXX to Allow Tapering of Inhaled Corticosteroids in Asthmatic Patients.

42. A Twelve-Month Safety Tolerance Study of 240 mg of XXX QD and Placebo QD in Normal HealthySubjects.

43. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of the Efficacy and Safetyof XXX (XXX) and XXX (XXX) Formulations of XXX (XXX) Metered Dose Inhaler (XXX) 2 mgQID in the Treatment of Asthmatic Patients 12 Years and Older Withdrawn from XXX InhalerMaintenance Therapy.

44. A Safety Study of XXX Syrup in Children with Allergic Rhinitis.

45. A Two-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel, Multicenter Study to Assess theSafety and Efficacy of XXX (160 and 320 mg BID) in the Treatment of Adults with Seasonal AllergicRhinitis.

46. A Placebo-Controlled, Double-Blind Study of the Safety and Efficacy of XXX Aqueous Nasal Spray inChildren with Perennial Allergic Rhinitis.

47. A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Clinical Effect of XXXto Placebo in Patients with Chronic Asthma.

48. Prospective, Controlled, Randomized, Non-Blinded, Multicenter Clinical Trial of XXX Otic Drops withor without XXX vs. XXX Otic Drops in the Treatment of Acute Diffuse Bacterial External Otitis.

49. Randomized, Double-Blind, Six-Week, Placebo-Controlled, Parallel Comparison of XXX Nasal Spray0.03% (42 mcg per Nostril TID) Alone, and the Combination of XXX Nasal Spray with XXX Nasal

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Spray in Perennial Rhinitis Patients with an Optional Six-Month, Double-Blind, Active, ControlledTreatment Comparison of XXX Nasal Spray 0.03% (42 mcg per Nostril TID) vs. XXX (84 mcg perNostril BID).

50. A Double-Blind Comparison of Four Doses of XXX (XXX) Aqua Pump Spray Perennial and Placebo inthe Treatment of Adults and Children with Seasonal Allergic Rhinitis.

51. A Double-Blind, Randomized, Placebo-Controlled, Parallel Study Comparing the Efficacy and Safety ofThree-Dosage Strengths of XXX (60, 120, & 240 mg BID) in the Treatment of Fall Allergies.

52. A Dose Response Study of XXX in Male and Female Patients with Seasonal Allergic Rhinitis.

53. XXX vs. Components vs. Placebo in Patients with Seasonal Allergic Rhinitis.

54. An Open-Label, Long-Term Study of the Safety of XXX Nasal Inhaler in Patients with Perennial AllergicRhinitis.

55. A Two-Week, Double-Blind, Parallel, Multicenter Study of the Safety and Efficacy of XXX vs. XXX andPlacebo in the Treatment of Seasonal Allergic Rhinitis.

56. A Double-Blind, Parallel, Multicenter Study of the Safety and Efficacy of XXX and XXX vs. Placebo inthe Treatment of Seasonal Allergic Rhinitis in Children.

57. A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Comparative Trial of Inhaled XXX viaDiskhaler 500 mcg BID, Multi-Dose Powder Inhaler 500 mcg BID, and Placebo in Adolescent andAdult Patients with Mild-to-Moderate Asthma.

58. Efficacy of XXX vs. XXX vs. Placebo upon Awakening in Seasonal Allergic Rhinitis (SAR).

59. A Chronic-Use Study of XXX in Patients with Perennial Allergic Rhinitis.

60. Double-Blind, Placebo-Controlled Efficacy Study of Total Daily Doses of 200, 400, 600, & 800 mcg BIDof XXX in Moderate Asthma.

61. Double-Blind, Randomized, Comparative, Multicenter Study of XXX vs. XXX in the Treatment ofAcute Bacterial Exacerbations of Chronic Bronchitis.

62. Randomized, Double-Blind, Parallel Comparison of XXX Nasal Spray 0.03% vs. Placebo AdministeredTwice a Day in Patients with Allergic or Non-Allergic Perennial Rhinitis.

63. An Investigator-Blind, Randomized, Comparative, Multicenter Study of XXX 600 mg QD and 300 mgBID vs. XXX 500 mg TID in the Treatment of Acute Maxillary Sinusitis for Ten Days.

64. Double-Blind, Randomized XXX Inhaler vs. Placebo in Treating Adolescents with Seasonal RagweedAllergy.

65. A Placebo-Controlled Study to Compare the Efficacy and Safety of XXX and XXX in the Treatment ofSeasonal Allergic Rhinitis.

66. A 12-Week, Open-Label, Multicenter Study of the Safety of XXX Syrup in the Treatment of PerennialAllergic Rhinitis in Children 6-11 Years of Age.

67. XXX vs. XXX vs. Placebo in Patients with Seasonal Allergic Rhinitis.

68. A Randomized, Double-Blind, Parallel-Group Trial to Assess the Topical vs. Systemic Efficacy of XXXTablets 20 mg QD and Placebo in Adult Patients with XXX Tablets 20 mg QD and Placebo in AdultPatients with Moderate Asthma.

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69. A Prospective, Controlled, Double-Blind, Randomized, Multicenter Clinical Trial Comparison of theSafety and Efficacy of XXX vs. XXX in the Treatment of Patients with Acute Sinusitis.

70. Study of the Efficacy and Safety of XXX vs. XXX in the Treatment of Acute Maxillary Sinusitis.

71. A Double-Blind Randomized, Parallel Study Comparing the Efficacy and Safety of XXX HCl 120 mgQ.D., 180 mg Q.D., XXX HCl 10 mg Q.D., and Placebo in the Treatment of Perennial Allergic Rhinitis.

72. Placebo-Controlled Efficacy and Safety Study of XXX Dry Powder Inhaler (MF DPI) in the Treatmentof Asthma in Children Preciously Maintained on Inhaled Corticosteroids.

73. A Multicenter, Double-Blind Comparison of XXX with Placebo in Pediatric Subjects with Mild-to-Moderate Asthma.

74. Once Daily XXX v. XXX 3 times daily v. Placebo.

75. Randomized Double-blind Placebo-Controlled Double-Dummy Comparing Efficacy of Intranasal XXXand Intramuscular XXX in Patient's with SAR.

76. XXX v. XXX in Treating Sinusitis.

77. XXX v. XXX in Treating Bronchitis.

78. Randomized Double-Blind Parallel Comparison of XXX Nasal Spray v. Placebo Administered Twice aDay in Patient's with PNAR.

79. Double-blind Multiple-dose Placebo-controlled Dose Response Study of XXX in Adult Patients withSeasonal Ragweed Allergy.

80. A Placebo-Controlled Double-Blind Study of the Safety and Efficacy of XXX Nasal Inhaler in Patientswith Perennial Non-allergic Rhinitis.

81. XXX vs. Placebo - A Sleep Disorder Study

82. Double-blind Randomized Placebo-controlled Study of the Efficacy and Safety of Aqueous XXX GivenTwice Daily vs. Placebo for Four Weeks in Patients with PNAR.

83. A Double-Blind Randomized XXX Inhaler vs. Placebo in Treating Adolescents with Seasonal RagweedAllergy.

84. Double-Blind Parallel Group Randomized Comparison of XXX and Placebo in Patients with SeasonalAllergic Rhinitis.

85. Open-label Long-term Safety Study of XXX in Patients with Pollen-induced Allergies.

86. A Double-Blind Crossover Comparison of the Efficacy of XXX Aqueous Nasal Spray vs. XXX in theTreatment of Seasonal Allergic Rhinitis in Adults.

87. A 12-week, Open-label, Multi-center Study of the Safety of XXX Syrup in the Treatment of PerennialAllergic Rhinitis in Children 6-11 Years of Age.

88. Randomized, Double-blind, Crossover comparison of the combination of XXX Nasal Spray with XXXvs. XXX alone administered three times a day in patients with allergic and nonallergic perennial rhinitis.

89. A Randomized, Double-blind, Double-dummy, Parallel-group, Comparative Trial of Inhaled XXXRotadisks via Diskhaler 500 mcg Bid, Multi-dose Powder Inhaler 500 mcg Bid, and Placebo inAdolescent and Adult Patients with Mild-to-Moderate Asthma

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90. Placebo-Controlled Efficacy and Safety Study of XXX Metered Dose Inhaler (MF-MDI) in theTreatment of Asthma in Children Previously Maintained on Inhaled Corticosteroids.

91. Efficacy and Safety of XXX in the Prophylaxis of Subjects with Seasonal Allergic Rhinitis.

92. A Randomized, Double-Blind, Double-Dummy, Parallel Group, 12-Week Comparative Trial of XXXPropionate Combination Product 50/100mcg BID Via the DISKUS Inhaler Versus Oral XXX 10mgQD in Adolescents and Adults with Persistent Asthma.

93. A Phase III Double-Blind Efficacy and Safety Study of XXX (10 mg) in Addition to XXX Compared toPlacebo in Subjects with Primary Hypercholesterolemia.

94. Randomized, Double-Blind, Multicenter Study to Evaluate the Effect of Adding Either XXXor XXX toInhaled XXX in Adult Asthmatics.(XXXl vs XXX for Asthmatics who Require more Therapy (SMARTstudy).

95. A Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of XXXInhalation Powder (250mcg QD) and Placebo in Subjects at Least 12 Years of Age with Chronic AsthmaCurrently Receiving Short Acting Beta Agonist Alone.

96. A Randomized, Double-Blind, Parallel Group Studies Evaluating The Protective Effects of the XXXCombination Product (50/100 mcg via Diskus) Against Bronchospasms Induced By Activity AsMeasured By Exercise Challenge Testing in Adolescent and Adult Subjects Who Require Chronic InhaledCorticosteroid Therapy for the Treatment of Persistent Asthma.

97. A Randomized, Double-Blind, Parallel-Group Study Evaluating the Protective Effects of the XXXCombination Product (50/250mcg BID via DISKUS) against Bronchospasms Induced by Activity asMeasured by Exercise Challenge Testing in Adolescent and Adult Subjects who Require Chronic InhaledCorticosteroid Therapy for the Treatment of Persistent Asthma.

98. A Multicenter, Double-Blind, Randomized, Parallel Groups Placebo-Controlled Pilot Study to Observethe Effects of XXX 10mg in Combination with XXX 180 mg daily or 120 mg BID on Asthma Subjectswith Persistent Mild to Moderate Atopic Asthma.

99. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose, Multicenter, 12 WeekStudy to Compare The Safety and Efficacy of XXX Via the "To-Be-Marketed" Spiros® Dry PowderInhaler to XXX Metered-Dose Inhaler in Patients with Asthma.

100. A Multicenter, Double-Blind, Randomized, Parallel Groups Placebo-Controlled Pilot Study to Observethe Effects of XXX 10mg in Combination with XXX 180 mg daily or 120 mg BID on Asthma Subjectswith Persistent Mild to Moderate Atopic Asthma.

101. Bronchodilation Bioequivalence Study of XXX-HFA-MDI and XXXHFA.

102. A Study of the Effect of XXX 5mg and XXX 240 mg on Nasal Stuffiness in Subjects with SeasonalAllergic Rhinitis.

103. Efficacy and Safety of XXX 5 mg Tablet in the Treatment of Subjects 12 to 17 Years of Age withSeasonal Allergic Rhinitis.

104. A Randomized, Double-Blind, Parallel Group Comparative Trial of XXX Combination Product50/100mcg DISKUS Inhaler BID versus XXX 250mcg DISKUS Inhaler BID in Adolescents and Adultswith Moderate Persistent Asthma.

105. A Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of XXX InhalationPowder (250mcg QD) and Placebo in Subjects at Least 12 Years of Age With Chronic Asthma CurrentlyTreated with Inhaled Corticosteroids.

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106. A Double-blind, Randomized, Placebo-controlled, Parallel Group Study Assessing the Efficacy andSafety of Oral XXX HCL 30 mg Tablets Twice a Day in Pediatric Subjects (6-11 years) in the Treatmentof Seasonal Allergic Rhinitis.

107. XXX Cardiovascular Treatment Assessment Versus XXX (OCTAVE)

108. Efficacy and Safety of Combination XXX QD vs. its Components in the Treatment of Subjects withSeasonal Allergic Rhinitis.

109. A Multicenter, Double Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect ofXXX in Patients With Seasonal Allergic Rhinitis - Fall Study.

110. A Randomized, Double-Blind, Double Dummy, Parallel Group Comparison of XXX Inhalation Powder(50mcg BID) via DISKUS® with Oral XXX (5mg QD) Chewable Tablets in Children 6 - 12 years of Agewith Persistent Asthma.

111. A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect ofXXX in Patients With Seasonal Allergic Rhinitis - A Pilot Study During the Fall Season.

112. A Placebo-Controlled, Environmental Study of XXX Nasal Spray Versus XXX in the Treatment ofSeasonal Allergic Rhinitis.

113. Efficacy and Safety of Two Formulations of XXX Compared to XXX and XXX in the Treatment ofSubjects with Seasonal Allergic Rhinitis.

114. A Randomized, Double-Blind, Multicenter Study to Evaluate the Effect of Adding Either XXX or XXXto Inhaled XXX in Adult Asthmatics.

115. Prospective, Randomized, Double-Blind, Three-armed, Multi-Center, Comparative Trial to Evaluate theEfficacy and Safety of XXX 300 mg PO BID for 7 days vs. XXX 300 mg PO BID for 10 days vs. XXX250 mg PO BID for 10 days in the Treatment of Acute Bacterial Sinusitis.

116. A Randomized, Open-Label, Parallel-Groups, Outpatient Study to Examine the Safety and Tolerabilityof XXX 5 mg P.O. for the Acute Treatment of Migraine in Adolescents.

117. A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 12-week Trial of Inhaled XXX88mcg BID, 220mcg BID and 440mcg BID versus Placebo in Propellant XXX in Adolescent and AdultSubjects with Asthma who are Maintained on Inhaled Corticosteroid Therapy.

118. A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 12-week Trial of Inhaled XXX88mcg BID, 220mcg BID and 440mcg BID versus Placebo in Propellant XXX in Adolescent and AdultSubjects with Asthma who are Maintained on Bronchodilator Therapy.

119. Phase II Safety and Efficacy Study of Nebulized XXX in Asthma.

120. Placebo Controlled Efficacy and Safety Study of Once Daily PM and Twice Daily Regimens of XXXAdministered Via Dry Powder Inhaler in Subjects with Asthma who were Previously Maintained onInhaled Corticosteroids.

121. XXX Efficacy and Safety Study.

122. Long-Term, Safety and Tolerability Study of XXX (10mg)} or Placebo in Addition to XXX in Subjectswith Primary Hypercholesterolemia.

123. A Multicenter, Stratified, Randomized, Double-Blind, Parallel-Group, Step-Up Comparison of the Levelof Asthma Control Achieved with XXX Combination Diskus™ (Accuhaler™) Dry Powder InhalerCompared with XXX Diskus™ (Acculaher™) Alone in adults and Adolescents.

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124. Efficacy and Safety of 200mcg or 400mcg of XXX Nasal Spray or Placebo in the Treatment of NasalPolyps.

125. A Phase III, Multicenter, Double-Blind, Placebo Controlled, Non-Inferiority Study Assessing the Effectsof XXX Metered Dose Inhaler 50 g/Day and 200 g/Day (Ex-Valve) Administred Once Daily onGrowth in Children with Mild Persistent Asthma.

126. A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Clinical Trial ofFour Weeks Treatment with XXX Inhalation Aerosol, 25mcg BID, 50mcg BID, and PlaceboAdministered Via a Valved Holding Chamber with Facemask in Subjects with Asthma Age 24 to 47Months.

127. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess theEfficacy of a Four-Week Course of XXX Aqueous Nasal Spray (200mcg QD)on Ocular SymptomsCommonly Associated with Allergic Rhinitis.

128. A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing XXX With Placebo inPediatric Patients Aged 2 Through 14 Years With Seasonal Allergic Rhinitis.

129. Double-blind, Placebo Controlled, Randomized, Parallel Group Study of Four Doses of XXX NasalSpray (100 g, 400 g, and 800 g) with XXX (200 g) as an Open Active Control in the Treatment ofAdults and Adolescents with Allergic Rhinitis Induced by Grass Pollen.

130. A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacyand Safety of XXX vs. XXX vs. Placebo in the Treatment of Children with Seasonal Allergic Rhinitis.

131. Efficacy and Safety of Combination XXX QD vs. XXX and placebo in the Treatment of Subjects withSeasonal Allergic Rhinitis.

132. A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Effect of XXX inPatients With Seasonal Allergic Rhinitis.

133. Safety and Efficacy of XXX Nasal Spray 0.1% versus XXX Nasal Spray Vehicle in the Prevention ofSymptoms of Seasonal Allergic Rhinitis with XXX HCl Nasal Spray 0.1% (XXX) as a ReferenceStandard.

134. A Placebo Controlled, Double Blind, Double-Dummy, Multicenter, 6 Weeks Study of OrallyAdministered 60mg XXX in the Treatment of Adult Patients with Asthma Compared to Treatment with176 g XXX.

135. A Phase II Study Designed as a Double-Blind, Randomized, Parallel Group, Placebo Controlled Studyof Three Different Maintenance Doses of Orally Administered Microencapsulated Ragweed PollenExtract.

136. A Pilot Study of the Effect of XXX on Nasal Congestion in a Subset of Subjects with Seasonal AllergicRhinitis.

137. A Phase III Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Efficacy, Safety and DoseResponse Study of XXX Metered Dose Inhaler 100 g/Day, 200 g/Day, and 400 g/Day (Ex-Valve)Administered Once Daily For 12-Weeks In The Treatment of Mild To Moderate Persistent Asthma InAdolescents and Adults.

138. A 12-week randomized, multicenter, double-blind, placebo controlled, parallel group study in children(aged 5 - 12, inclusive) with persistent asthma evaluating the safety, efficacy, and pharmacokinetics ofXXX 10 g b.i.d. delivered by the multi-dose dry powder inhaler (MDDPI) versus placeb.

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139. A double-blind, double-dummy, parallel-group multi-center, randomized, study of XXX HCl 180 mg vsXXX HCl mg in subjects with moderate to severe seasonal allergic rhinitis (SAR) during the fall allergyseason.

140. A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effects ofXXX in Patients with Seasonal Allergic Rhinitis Over a 4-Week Treatment Period-Fall 2001.

141. Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of Once-Daily XXXHFA Inhaler System in Patients with Asthma Currently Treated with Inhaled Steroids.

142. Placebo Controlled Efficacy and Safety Study of XXX Administered Via Dry Powder Inhaler in theTreatment of Asthma in Children Previously Maintained on Inhaled Corticosteroids.

143. A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, Multicenter Study to Assess theSafety and Efficacy of XXXNasal Spray 1.042% in Adolescent and Adult Patients With Seasonal AllergicRhinitis.

144. A Randomized, Open-Label, Cross-Over Trial, Assessing Correct Use and Patient Preference of XXXInhalation Powder (100mcg BID) via the DISKUS versus XXX Aerosol via the Metered Dose Inhaler(88 mcg BID) in Subjects at Least 12 Years of Age with Persistent Asthma Currently Receiving ShortActing Beta Agonists Alone.

145. A Multi-center, Randomized, Double-Blind, Double-Dummy, Parallel Group, 16-Week Comparison ofAsthma Control in Adolescents and Adults Receiving Either XXX DISKUS Combination Product100/50mcg BID, XXX DISKUS 100mcg BID, XXX DISKUS 50 mcg BID, or Oral XXX 10mg QD.

146. A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, MulticenterStudy to Examine the Effect of Glucose Control (HbA1c) of XXX Given Two Times a Day in Subjectswith Type 2 Diabetes Mellitus Treated with XXX Alone.

147. A Multicenter, Double-Blind, Placebo Controlled, Randomized Clinical Trial to Compare the Efficacyand Safety of XXX 20mg, XXX 10mg and Placebo All Given Once Daily for Four Weeks in theTreatment of Seasonal Allergic Rhinitis.

148. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating theEfficacy and Safety of the XXX DISKUS Combination Product 250/50mcg Once Daily versus XXXDISKUS Combination Product 100/50mcg Twice Daily versus XXX DISKUS 250mcg Once Dailyversus Placebo in Symptomatic Adolescent and Adult Subjects with Asthma That is Not Controlled onShort Acting Beta2agaonists alone.

149. A Randomized, Double-Blind 36-Week Trial Comparing Impact of Breakthrough Bleeding inPostmenopausal Women on femhrt or Prempro in a Managed Care Setting.

150. A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 12-week Trial of Inhaled XXX 88mcg BID versus Placebo in Propellant XXX in Pediatric Subjects 4 to 11 Years of Age with Asthma.

151. 12 weeks treatment with 250ug XXX versus placebo in patients with asthma.

152. A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Study to Assess the Safety andTolerability of XXX 15mg in Children with Allergic Rhinitis.

153. A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of XXXversus Placebo in Patients with Seasonal Allergic Rhinitis and Concomitant Mild to Moderate Asthma.

154. A 12-week randomized, multicenter, double-blind, double-dummy, placebo and active controlled,parallel group study evaluating the safety and efficacy of XXX (ug b.i.d.) delivered by the multi-dose drypowder inhaler (MDDPI) versus placebo versus XXX pMDI q.i.d. in patients with persistent asthma.

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155. A Repeat-Dose, Placebo-and-Active-Controlled Multicenter Efficacy and Safety Study of a TabletContaining XXX 200mg, XXX 30mg, and XXX 15mg in Subjects with Symptoms of Cold or Flu.

156. A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluatingthe Safety & Efficacy of the XXX DISKUS Combination Product 100/50mcg Once Daily versus XXXDISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4 - 11 Years WithAsthma).

157. A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter, Pilot Efficacyand Safety study of XXX Administered by Inhalation Twice Daily for Twelve Weeks in Adults with Mildto Moderate Persistent Asthma.

158. A Study to Determine the Efficacy and Safety of XXX in the Symptomatic Treatment of ChronicUrticaria.

159. A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating theClinical Effects of XXX in Patients with Perennial Allergic Rhinitis.

160. A Double-Blind, Placebo Controlled Study of the Effect of XXX in Subjects with Perennial AllergicRhinitis.

161. A Randomized (2:1), Stratified, Double-Blind, Parallel-Group, Placebo-Controlled, 12-week, Multi-Center Trial of XXX HFA Inhalation Aerosol 88mcg BID versus Placebo HFA Delivered via an MDIand a Valved Holding Chamber with Facemask in Pediatric Subjects 1 to <4 Years of Age with Asthma.

162. A Phase IIIA, Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study onthe Efficacy and Safety of XXX 180 mg Once Daily in Chronic Idiopathic Urticaria.

163. A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, MulticenterStudy to Examine the Effect of Glucose Control (HbA1c) of XXX Given Two Times a Day in Subjectswith Type 2 Diabetes Mellitus Treated with XXX Alone.

164. A Double-Blind, Randomized, Placebo Controlled, Multi-Center, Phase Ii Study with Five ParallelGroups, Comparing the Efficacy and Safety of Oral XXX Immediate Release (IR) 7mg, 10 mg. and 15mg Tablets Administered Twice a Day and Oral XXX Extended Release (ER) 35 mg TabletsAdministered Once A Day in the Morning for Two Weeks versus Placebo in Adult Subjects SufferingFrom Seasonal Allergic Rhinitis to Grass and Weed Pollen.

165. A Multicenter, Open-Label, Long-Term (1 year) Safety Study of XXX 100 g/Day (Ex-Valve) MeteredDose Inhaler Administered ONCE Daily For The Treatment of Mild to Moderate Persistent Asthma inAdolescents and Adults.

166. A Randomized, Double-Blind, 12-Week Trial Evaluating the Safety of the XXX DISKUS CombinationProduct 100/50 mcg BID versus XXX DISKUS 100 mcg BID in Symptomatic Pediatric Subjects (4-11Years) with Asthma.

167. A Multicenter, Open-Label, Randomized, Parallel Groups Study to Assess the Long Term SafetyPerformance of XXX Compared to XXX in Subjects with Asthma.

168. A Multicenter, Double-Blind, Randomized, Parallel Groups Placebo-Controlled Study to Assess theEfficacy and Safety of XXX 120 mg BID in Subjects with Mild to Moderate Persistent Asthma.

169. A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of XXX versusits Mono-Products XXX in Adolescents ( 12 Years of Age) and Adults with Asthma.

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170. A Twelve-Week, Randomized, Double-Blind, Double-Dummy Trial of XXX Versus its Mono-ProductsXXX in Asthmatic Children Aged Six to Fifteen Years.

171. Children’s XXX Allergy Sinus Suspension Multiple Dose Safety Study in Children 6 to <12 Years of Agewith Symptoms Consistent with Allergic Rhinitis.

172. An Efficacy and Safety Study of XXX, XXX and Placebo in Subjects Twelve Years of Age and Olderwith Asthma.

173. Dose-ranging Study of XXX in Patients with Persistent Asthma Not Treated with InhaledCorticosteroids.

174. A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel Group, four-Week Study Assessing the Efficacy of XXX Aqueous Nasal Spray 200 mcg QD versus XXX 10 mg QDin Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who Are ReceivingConcurrent Open-Label XXX 100/50mcg BID.

175. A Multicenter, Double-Blind, Randomized, Parallel Study Comparing the Efficacy and Safety of XXX120 mg BID, XXX 240 mg QD, and Placebo in Subjects with Perennial Allergic Rhinitis.

176. A Multicenter, Randomized, Double-Blind, Crossover Study Comparing the Effect of XXX and Placeboin Adult Patients with Chronic Asthma.

177. A Placebo-and Active-Controlled Efficacy and Safety Study of a Once-Daily Fixed Combination Tabletof XXX 5 mg/XXX 120 mg in subjects with Seasonal Allergic Rhinitis.

178. A Multicenter, Double-Blind, Randomized, Parallel Study Comparing the Efficacy and Safety of XXX120 mg BID, XXX 240 mg QD, and Placebo in Subjects with Perennial Allergic Rhinitis.

179. A Randomized, DoubleBlind, Placebo Controlled, Parallel Group Study to Assess the Safety andEfficacy of Three Dose Levels of XXX in the Treatment of Chronic Plaque Psoriasis.

180. A Double-Blind, Placebo Controlled Study of the Efficacy and Tolerability of Once Daily XXX vs.Placebo in the Treatment of Subjects with Osteoarthritis of the Knee Non-Responsive to XXX andXXX.

181. Randomized, Double-Blind, Placebo-Controlled Trial of XXX Nasal Spray, XXX and XXX Nasal Sprayplus XXX in Patients with Seasonal Allergic Rhinitis

182. A Placebo-Controlled, Efficacy and Safety Study of XXX Nasal Spray for the Treatment of SeasonalAllergic Rhinitis.

183. Double Blind Study of the Efficacy, Safety and Pharmacoeconomics of XXX Inhaler System asCompared to XXX Aerosol in Patients with Asthma.

184. A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of XXXAdministered Once Daily in Children and Adolescents 6 to 15 Years of Age with Asthma - SPROUT,

185. A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-and-Active Controlled Study ofXXX Administered Once Daily in Adults and Adolescents with Asthma - STEM.

186. A Phase IV Safety Trial in Pediatric Patients (Ages 2 - 5) with Rhinorrhea Associated with a CommonCold or Allergy

187. A Randomized, Double-Blind, Parallel-Group Multicentre Efficacy and Safety Phase IIB Pilot Study ofXXX twice daily versus placebo twice daily in Adult Asthmatics treated for 4 Months.

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188. A Multi-Center, Randomized, Double-Blind, Parallel Group, 40-Week, Comparison of Asthma ControlUsing Bronchial Hyperresponsiveness as an Additional Guide to Long Term Treatment in Adolescentsand Adults Receiving Either XXX or XXX or Placebo if Asymptomatic.

189. A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of XXX NasalSpray versus Placebo in Subjects with Perennial Allergic Rhinitis.

190. A Randomized, Partly Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of XXX at0.5 mg QD, 1.0 mg QD, 1.0 mg BID, 2.0 mg BID and XXX at 400 mcg BID in Adolescents (12 Years ofAge and Older) and Adults with Moderate to Severe Asthma.

191. A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess the Efficacyand Safety of a Modified Release Formulation of XXX in Adult Primary Insomnia Patient with SleepMaintenance Difficulties.

192. Multiple-Dose Safety and Tolerance Study of XXX in Atopic Pediatric Subjects and Pediatric Subjectswith Chronic Idiopathic Urticaria, Ages 2 to < 12 Years, Who are Poor Metabolizers of XXX.

193. A Phase III, Open-Label, Outpatient Extension Study to Assess the Long-Term Safety of a ModifiedRelease Formulation of XXX in Adult Primary Insomnia Patients with Sleep Maintenance Difficulties.

194. A 52-week, randomized, double-blind, single-dummy, parallel-group, multicenter Phase III studycomparing the long-term safety of XXX wtice daily to XXX twice daily and XXX twice daily in adult andadolescent subjects with asthma.

195. The Safety and Efficacy of XXX Extended-Release Tablets in Migraine Prophylaxis: A Double-Blind,Placebo-Controlled Study in Adolescents.

196. A Randomized, Double Blind, Placebo Controlled Trial of XXX Nasal Spray 137 mcg and XXX NasalSpray 137 mcg plus XXX 60 mg. in Patients with Seasonal Allergic Rhinitis.

197. A Randomized, Double-Blind, Placebo-Controlled Trial of XXX Nasal Spray 137 mcg at a Dosage ofOne Spray per Nostril Twice Daily in Patients with Seasonal Allergic Rhinitis.

198. A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of XXX on AllergicRhinitis in Patients with Seasonal Allergic Rhinitis and Chronic Asthma.

199. Long Term Safety Study of XXX Nasal Spray.

200. A Twelve Week, Randomized, Double-Blind, Parallel Group Trial Comparing the Efficacy, Safety andTolerability of a 20 mg Daily Dose of XXX Oral Tablets to Placebo in Subjects with Mild to ModeratePersistent Asthma.

201. A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy andSafety of Oral XXX(250 mcg or 500 mcg) Daily in Patients with Asthma.

202. A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect ofXXX in Patients with Seasonal Allergic Rhinitis - a Pilot Study During the Fall Season.

203. A Phase III, Long Term, Open Label Study to Evaluate the Safety of Once Daily XXX in the treatmentof Psoriasis.

204. A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Four-Week Efficacy and SafetyEvaluation of XXX 110ug QD, followed by Six-Month Open-Label Safety in Children Ages 2-5 Yearswith Perennial Allergic Rhinitis.

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205. A Multi-Center, Multinational, Randomized, Double-Blind, Parallel Group Study of the Effects of XXX640 ug/Day and XXX 640 ug/Day on Lens Opacification in Adult Subjects with Moderate to SeverePersistent Asthma.

206. A Randomized, Double Blind, Placebo Controlled, Parallel Group Study of the Safety and Efficacy ofTwo Concentrations of XXX Applied Twice Daily in Adults with Mild to Moderate Atopic Dermatitis.

207. A Multicenter-Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating theClinical Effects of XXX in Patients with Perennial Allergic Rhinitis.

208. A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of XXXcombination product 100/50mcg BID versus XXX 100mcg BID in Pediatric and Adolescent Subjectswith Activity-Induced Bronchospasm.

209. Two-Stage Randomized, Open-Label, Parallel Group, Phase iii, Multicenter, 7-month Study to Assessthe Efficacy and Safety of XXX Administered either as Fixed or as an Adjustable Regimen versus a FixedRegimen of XXX in Subjects 12 Years and Older with Asthma.

210. Efficacy and Safety of 200 mcg QD or 200 mcg BID XXX Nasal Spray vs. XXX vs. Placebo as PrimaryTreatment of Subjects with Acute Rhinosinusitis

211. A Randomized, Controlled Study of XXX versus Placebo in Patients with Asthma.

212. A Double-Blind, Placebo Controlled Study of the Efficacy and Tolerability of Once Daily XXX vs.Placebo in the Treatment of Subjects with Osteoarthritis of the Knee Non-Responsive to XXX andXXX.

213. A Comparative Double-Blind, Double-Dummy Study of XXX 5 mg. Once Daily, XXX 10 mg OnceDaily, and Placebo Once Daily in Patients with Chronic Idiopathic Urticaria (CIU).

215. A Randomized, Double Blind, Placebo-Controlled Study Evaluating XXX in the Treatment ofOsteoarthritis of the Hip or Knee.

216. A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of XXX vs.XXX in Pediatric Subjects with Activity-Induced Bronchospasm.

217. A 1 Year, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter, Evaluation ofEfficacy, Safety, Pharmacokinetics and Pharmacodynamics of XXX in Children (6 - <12 years) withModerate-Severe, Persistent, Inadequately Controlled Allergic Asthma.

218. An Open-Label, Treatment Continuation Study of 1% XXX Cream Applied Twice Daily in Adults withAtopic Dermatitis Who Previously Completed a Double-Blind, Placebo-Controlled Study of XXX

219. A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate theClinical Effect of Oral XXX Versus Placebo During the Allergy Season in Patients with SeasonalAeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season.

220. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed toAssess the Efficacy and Safety of XXX Applied as a Nasal Spray at Three Dose Levels (200ug, 100ug, or25 ug, once daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 years of age.

221. A Randomized, Evaluator-Blinded Comparison of the Efficacy and Safety of XXX Otic Solution 0.2%with XXX and XXX and XXX Otic Solution in the Treatment of Acute Diffuse Otitis Externa inChildren, Adolescents, and Adults.

222. Safety and Efficacy Evaluation of Two Doses of XXX vs Placebo by Breath Operated and MeteredDose Inhalers in Moderate Asthmatic Adolescents and Adults on a Stable Regimen of Inhaled

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223. A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Phase II Study toAssess the Efficacy and Safety of XXX Nasal Spray, 16ug, 32ug, and 64ug per day versus placebo inPediatric Subjects, Ages 2-5 years Old With Allergic Rhinitis.

224. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center, Multiple Dose (7 days)Dose-Ranging Study to Assess the Efficacy and Safety of 4 Doses of XXX delivered via a Multiple DoseInhaler and 1 dose of XXX, Delivered via a Single Dose Inhaler in Adult and Adolescent Patients (12 -75 Years Old Inclusive) With Stable Persistent Asthma.

225. The Safety of XXX Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Studyin Adolescents.

226. A Placebo Controlled Study of the Efficacy and Safety of XXX vs. XXX in the Treatment of Subjectswith Symptomatic Seasonal Allergic Rhinitis.

227. Randomized, Double-Blind Trail of XXX Nasal Spray Compared to XXX in Patients with SeasonalAllergic Rhinitis.

228. A Multicenter, Randomized, Double-Blind, Crossover Study Comparing the Effect of XXX withPlacebo and Concomitant Administration of XXX Plus XXX in Adult Patients with Chronic Asthma.

229. Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control andMeasures of Airway Inflammation in Subject of African Descent Receiving XXX BID or XXX BIDAlone.

230. A Phase III, Investigator-Blind, Randomized, Parallel-Group, Multicenter Study to Evaluate the Safetyand Efficacy of XXX for 7 Days Compared to XXX for 10 days in the Treatment of Tonsillitis and orPharyngitis Secondary to Streptococcus Pyogenes in Pediatric Patients.

231. A placebo-and active-controlled XXX, randomized, parallel-group, dose-range finding study of XXXadministered by dry powder inhaler (Ultrahaler) in adult and adolescent patients with persistent asthma.

232. Safety and Efficacy of XXX Nasal Spray in Pediatric Patients.

233. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate theEfficacy and Safety of Once-Daily, Intranasal Administration of XXX Aqueous Nasal Spray 50mcg and100mcg for 12 Weeks in Pediatric Subjects Ages 2 <12 Years with Perennial Allergic Rhinitis (PAR).

234. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate theSafety and Efficacy of Once-Daily, Intranasal Administration of XXX Aqueous Nasal Spray 50mcg and100mcg for 12 Weeks in Pediatric Subjects Ages 2 <12 Years with Seasonal Allergic Rhinitis (SAR).

235. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate theEfficacy and Safety of Once-Daily, Intranasal Administration of XXX Aqueous Nasal Spray 100 mcg for4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) with Vasomotor/IdiopathicRhinitis.

236. A Pilot Efficacy and Safety Field Trial of XXX Administered Concomitantly with XXX , in Subjectswith Seasonal Allergic Rhinitis and Post-Nasal Drip.

237. A Double-Blind, Placebo–Controlled Evaluation of the Safety and Efficacy of Three Doses of TopicallyApplied XXX in Comparison to Oral XXX for the Treatment of the Signs and Symptoms ofOsteoarthritis of the Knee.

238. A Double-Blind, Long-Term Evaluation of the Safety of Topically Applied XXX in Comparison to OralXXX for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee.

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239. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess theEfficacy of XXX Metered-Dose Inhaler as a Daily Dose of 160 ug Administered for 12 Weeks Either ina Once-Daily Regimen in the Morning (10 ug qd AM) or in a Twice-Daily Regimen (80 ug bid) in Adultsand Adolescents with Mild to Moderate Persistent Asthma Treated Previously with InhaledCorticosteroids.

240. Safety and Efficacy Study of XXX Nasal Spray 665 mcg versus XXX Nasal Spray Vehicle versusXXX in Treatment of Seasonal Allergic Rhinitis. 9/2005

241. A multicenter, randomized, double-blind, triple-dummy, placebo-controlled, parallel group, four-weekstudy assessing the efficacy of XXX vs XXX in adolescent and adult subjects with asthma and seasonalallergic rhinitis who are receiving XXX or placebo. 3/2006

242. A multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study toassess the efficacy of XXX metered-dose inhaler at a daily dose of 160 ug qd administered either in aonce-daily in the morning regimen (160 ug qd AM) for 16 weeks or in a 160 ug qd AM regimen for 12weeks preceded by a twice-daily regimen (80 ug bid) for 4 weeks, or in an 80 ug bid regimen for 16weeks, in adults and adolescents with mild to moderate persistent asthma not treated with steroids.11/2005

243. A Randomized, Parallel Group, Double-Blind, Comparative Trail Assessing Lung Function and OtherMeasures of Asthma Control in Adults and Adolescents, at least 12 years of Age, with Persistent Asthma,Who Have Either a B16Arg/Arg, a B16- Gly/Gly or a B-16Arg-Gly Genotype and are treated with XXXor XXX. 11/2005

244. A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of XXX in Subjects with Persistent Asthma. 11/2005

245. Efficacy and Safety of Combination XXX vs. XXX and Placebo in the Treatment of Subjects withSeasonal Allergic Rhinitis.

246. Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of XXX in Patientswith Seasonal Allergic Rhinitis.

247. A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate theClinical Effect of oral XXX versus Placebo in Persistent Asthma Which is Also Active During AllergySeasons in Pediatric Patients with Seasonal Aeroallergen Sensitivity.

248. A Multicenter, Randomized, Open-Label Study to Assess the Functionality of XXX with an ActuationCounter during use by Children, Adolescents, and Adults with Stable, Inhaled Corticosteroid-DependentAsthma.

249. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess theSafety and Efficacy of XXX Appled as a Nasal Spray for Two Weeks in the Treatment of SeasonalAllergic Rhinitis (SAR) in Patients 6 to 11 Years of Age.

250. A 6-month Randomized, Double-Blind, Parallel-Group, Multicentre, Placebo-Controlled Phase II Studyto Compare Anti-Asthmatic Effect and Safety of XXX 40 mg twice daily or 40 mg. once daily withPlacebo in Adults with Asthma.

251. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 8-Week Study toEvaluate the Efficacy and Safety of Chewable XXX When Initiated at the Start of the School Year inPediatric Patients with Asthma”

252. A 21 Week Single-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XXX as aTreatment for Chronic Autoimmune Urticaria.

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Double-Blind, Placebo-Controlled, Comparative, Multi-Center, Parallel Groups Study.

254. Double-Blind Multi-Centre, Placebo-Controlled, Clinical Study to Evaluate the Clinical Equivalence of128 mcg of XXX Nasal Spray (Apotex, Inc., Canada) vs. 128 mcg of XXX Nasal Spray (AstraZeneca,USA) for the Indication of Seasonal Allergic Rhinitis.

255. A Placebo-Controlled Study of the Effects of XXX Nasal Spray on Common Cold Symptoms andAsthma Exacerbations Following Rhinovirus Exposure.

Updated 4/2007