Dear Healthcare Professional,

In the practice of medicine, the clinician has to make daily decisions on what is the best treatment for the

individual patient sitting in front of the clinician. The clinician usually relies on knowledge which has been gained from

training, previous experience as well as new clinical trial results in this decision-making process.

The randomised controlled trial is considered to be the highest level of scientific evidence, although these

trials are not without their own flaws and do not fill all the evidence gaps. For example, a clinical trial may

only address a few objectives in a specific patient population, which may or may not reflect clinical practice.

As a result, many clinical decisions are made based on observational data or even personal experience.

AstraZeneca, together with Professor James Ker, have developed a series of articles to enhance the clinician’s ability to

not only read an article on a new treatment but also to make a judgement call whether or not to treat their patients with

this new drug.

The articles will enable clinicians to read and evaluate not only randomised trials but also other sources of

evidence such as observational trials. This knowledge should enable clinicians to draw their own conclusions as to

whether a specific treatment is worthwhile or not. The series will keep to simple statistics and practical examples to en-

rich the clinician’s ability to make their own decisions.

For more information on the CLINICAL TRIAL INTERPRETATION series of articles, please speak to the AstraZeneca

Respiratory Representative in your area or contact Nina Nel at (011) 797-6000.

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S4 SYMBICORD® TURBUHALER® 80:4,5 µg/dose and 160:4,5 µg/dose (inhaler). Each delivered dose contains active constituents: Budesonide 80 micrograms and formoterol fumarate dihydrate 4,5 micrograms; Budesonide 160 micrograms and formoterol fumarate dihydrate 4,5 micrograms. S4 SYMBICORD® TURBUHALER® 320:9 µg/dose (inhaler). Each delivered dose contains active constituents: Budesonide 320 micrograms and formoterol fumarate dihydrate 9 micrograms. PHARMACOLOGICAL CLASSIFICATION: A.21.5.1 Corticosteroids and analogues. INDICATIONS: Asthma & COPD. SYMBICORD® TURBUHALER® 80:4,5 µg/dose, 160:4,5 µg/dose and 320:9 µg/dose are indicated in the treatment of asthma in adolescents and adults where use of a combination (inhaled corticosteroid and long-acting beta-2-agonist) is appropriate. SYMBICORD® TURBUHALER® 160:4,5 µg/dose and 320:9 µg/dose are indicated in the treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD), with frequent symptoms and history of exacerbations. Reg. No. SYMBICORD® TURBUHALER® 80:4,5 µg/dose: 35/21.5.1/0404. Reg. No. SYMBICORD® TURBUHALER® 160:4,5 µg/dose: 35/21.5.1/0405. Reg. No. SYMBICORD® TURBUHALER® 320:9 µg/dose: 38/21.5.1/0187. Symbicord® and Turbuhaler® are registered trademarks of the AstraZeneca group of companies. For full details relating to any information mentioned above please refer to the package inserts.

References:

1. Global Initiative for Asthma. (GINA). Global Strategy for Asthma Management and Prevention. 2012. http://www.ginasthma.com/GuidelinesResources.asp 2. Lalloo U, Ainslie G, Wong M, et al. Guidelines for the management of chronic asthma in adolescents and adults. SA Fam Pract 2007;49(5):19-31. 3. Abdool-Gaffar MS, Ambaram A, Ainslie GM, et al. Guideline for the management of chronic obstructive pulmonary disease – 2011 update. S Afr Med J 2011;101(1):61-73. 4. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2013. http://www.goldcopd.org/ 5. Sommers DeK. Allergic rhinitis. SA Fam Pract 2005;47(9):22-26. 6. ISAAC. Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) steering committee. Lancet 1998;351(9111):1225-1232. 7. History of the Turbuhaler® - A Swedish Invention and a global success. Available from www.symbicort Accessed 21/11/2013. 8. Green RJ, Hockman N, Friedman E, et al. Allergic rhinitis in South Africa: 2012 guidelines. S Afr Med J 2012;102(8):693-696. 9. Bricanyl® Turbuhaler package insert. 18 April 2008. 10. Oxis® Turbuhaler package insert. 15 January 2009. 11. Buhl R. Budesonide/formoterol for the treatment of asthma. Expert Opin Pharmacother. 2003;4;(8):1393-1406. 12. Pulmicort® Turbuhaler package insert. April 2004. 13. Rabe KF, Pizzichini E, Ställberg B, et al. Budesonide/formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma. Chest 2006;129:246-256. 14. Lalloo UG, Malolepszy J, Kozma D, et al. Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroid in adults with mild-to-moderate asthma. Chest 2003;123:1480-1487. 15. Bateman ED Harrison TW, Quince S, et al. Overall asthma control achieved with budesonide/formoterol maintenance and reliever therapy for patients on different treatment steps. Respir Res 2011;12:38. 16. Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007;61(5):725-736. 17. Symbicord® Turbuhaler 80(160)/4,5 Inhaler package insert. 14 September 2012. 18. Symbicord® Turbuhaler 320/9 Inhaler package insert. 14 September 2012. 19. Calverley PM, Boonsawat W, Cseke Z, et al. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J 2003;22:912-919. 20. Welte T, Miravitlles M, Hernandez P, et al.to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2009;180:741-750. 21. Larsson K, Janson C, Lisspers K, et al.salmeterol in preventing exacerbations in chronic obstructive pulmonary disease. J Intern Med 2013;doi:10.1111/joim.12067. 22. Rhinocort® Aqueous Nasal Spray package insert. 23. Dewar MH, Jamieson A, McLean A, et al. Peak

Resp Med 1999;93:342-344. 24. Pharmacy Update Feb 11. Astrazeneca’s Turbuhaler recognized at international Good Design Award. http://www.edoc.co.za/modules (Accessed 20/5/2011). 25. Borgström L, Derom E, Stähl E, et al Am J Respir Crit Care Med 1996;153:1636-1640. 26. Fitzgerald DA, Kilham HA. Croup: assessment and evidence-based management. Med J Aust 2003;179(7):372-377. 27. Borgström L, Asking L, Thorsson L. Idealhalers or realhalers? A comparison of Diskus and Turbuhaler. Int J Clin Pract Archives Dis Childhood 1990;65:309-319. 29. Cetinkaya F, Tüfekçi BS, Kutluk G. A comparison of nebulized budesonide, and intramuscular, and oral dexamethasone for treatment of croup. Int J Pediatr Otorhinolaryngol 2004;68(4):453-456. 30. Croup. http://www.patient.co.uk (Accessed 9/11/2011. 31. ISAAC. Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) steering committee. Lancet 1998;351(9111):1225-1232. 32. Klassen TP, Feldman ME, Watters LK, et al. Nebulized budesonide for children with mild-to-moderate croup. New Engl J Med 1994;331(5):285-289. 33. Godden CW, Campbell MJ, Hussey M, Cogswell JJ. Double blind placebo controlled trial of nebulised budesonide for croup. Arch Dis Childhood 1997;76:155-158. 34. Husby S, Agertoft L, Mortensen S, Pedersen S. Treatment of croup with nebulised steroid (budesonide): a double blind, placebo controlled study. Arch Dis Childhood 1993;68:352-355. 35. Pulmicort Nebulising Suspension package insert. 2007.

S3 Pulmicort® Turbuhaler® 100 µg/dose (Inhaler). Reg. No: Y/21.5.1/171. S3 Pulmicort® Turbuhaler® 200 µg/dose (Inhaler). Reg. No: Y/21.5.1/172. S3 Pulmicort® Turbuhaler® 400 µg/dose (Inhaler). Reg. No: Z/21.5.1/266. Each metered dose contains 100 µg, 200 µg or 400 µg budesonide. Free from propellants, lubricants, preservatives, carrier substances or other additives. PHARMACOLOGICAL CLASSIFICATION: A 21.5.1 Corticosteroids and analogues. INDICATIONS: Prophylaxis of the symptoms of asthma. For full prescribing information, kindly refer to the approved package insert.

S4 Oxis® Turbuhaler® 9 (Inhaler). Reg. No: 32/10.2.1/0168. Each dose delivers: formoterol fumarate dihydrate 9 µg. The corresponding metered dose contains 12 µg formoterol fumarate dihydrate. PHARMACOLOGICAL CLASSIFICATION: A 10.2.1. Bronchodilators (inhalants). INDICATIONS: Add on therapy to maintenance treatment with inhaled corticosteroids for the prophylaxis and treatment of reversible airways obstruction in asthma, chronic bronchitis and emphysema and prevention of bronchospasm in exercise-induced asthma, when adequate treatment with corticosteroids is not sufficient. For full prescribing information, kindly refer to the approved package insert.

S2 Bricanyl® Turbuhaler® 0,5 mg/dose (Inhaler). Reg. No: X/10.2/155. Each dose contains: terbutaline sulphate 0,5 mg. PHARMACOLOGICAL CLASSIFICATION: A 10.2 Bronchodilators. INDICATIONS: Bronchial asthma, chronic bronchitis, emphysema and other lung diseases where bronchospasm is a complicating factor. For full prescribing information, kindly refer to the approved package insert.

S3 Rhinocort® Aqua 32 (Nasal Spray). Reg. No: 32/21.5.1/0608. S3 Rhinocort® Aqua 64 (Nasal Spray). Reg. No: 32/21.5.1/0609. Each metered dose contains budesonide 32 µg or 64 µg. Contains potassium sorbate 0,12 % m/v as preservative. PHARMACOLOGICAL CLASSIFICATION: A 21.5.1 Corticosteroids and analogues INDICATIONS: Seasonal and perennial allergic rhinitis in adults and in children 6 years and older. For full prescribing information, kindly refer to the approved package insert.

AstraZeneca Pharmaceuticals (Pty) Ltd. Reg. No. 1992/005854/07. Building 2, Northdowns Office Park, 17 Georgian Crescent West, Bryanston, 2191. Private Bag X23, Bryanston, 2021. Tel: 011 797-6000. Fax: 011 797-6001. www.astrazeneca.co.za. Expiry date: June 2015. Log. No:

S3 Pulmicort® Nebulising Suspension 0,25 mg/ml (Suspension). Reg. No: 30/21.5.1/0017. S3 Pulmicort® Nebulising Suspension 0,5 mg/ml (Suspension). Reg. No: 30/21.5.1/0016. PULMICORT Nebulising Suspension is an aqueous suspension of budesonide adjusted to a pH of 4,5 with buffer. Each ml contains 0,25 mg or 0,5 mg budesonide. PHARMACOLOGICAL CLASSIFICATION: A 21.5.1 Corticosteroids and analogues. INDICATIONS: Indicated for the management of asthma in patients inadequately controlled by bronchodilators, thus necessitating additional treatment with steroids and who are unable to use a pressurised metered dose inhaler or unable to inhale the medicine in powder form. Also recommended for use in infants and children with acute laryngotracheobronchitis-croup. For full prescribing information, kindly refer to the approved package insert.

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Clinical Trial Interpretation Programme -How to Read and Evaluate Clinical Trials

Activity ID: 108417

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