· gemzel hernandez,2 naitee ting,2 richard zuwallack3 ... mepolizumab vs. ... bromide/fonnoterol...

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MORGANTOWN PULMONARY ASSOCIATES, P.C. Roger A. Abraham.it, M.D .• FCCP 1265 Pineview Drive Morgantown. JW 26505 Andrzej J. Jaworski, M.D., FCCP, D.A.B.S.M. Phone 304-598-2336 Fax J0.4-598-3717 NAME: DATE OF BffiTH: ROME ADDRESS: BUSINESS ADDRESS: GRADUATE TRAINING: PROFESSIONAL EXPERIENCE: Pulmonary Diseases Critical Cure Sleep Medicine Occuputional Lung Disease CURRICULUM VITAE ROGER A. ABRAHAMS, M.D., F.C.C.P. Morgantown Pulmonary Associates, P.C. & Morgantown Pulmonary Clinical Research 1265 Pineview Drive Morgantown, WV 26505 Fellowship in Pulmonary Medicine Saint Vincent Hospital Major Affiliate: University of Massachusetts Medical School ,..,, c:a Cl"\ :JC > ::0 CJ1 :x:a :JC '? N \D 1983-1985 Residency in Internal Medicine 1981-1983 Stamford Hospital, Stamford, Connecticut Major Affiliate: New York Medical College Chief Resident: 8/82 - 1/83 Internship in Internal Medicine 1979-1980 Long Island Jewish Medical Center New Hyde Park, NY Major Affiliate: State University of New York at Stonybrook Private Practice President Morgantown Pulmonary Associates, P.C. 1265 Pineview Drive Morgantown, WV 26505 8/8 7-Present a fgo n:E -fC"') (/) C"l 03'. ::2 C"') C"l fT1

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MORGANTOWN PULMONARY ASSOCIATES, P.C. Roger A. Abraham.it, M.D .• FCCP 1265 Pineview Drive

Morgantown. JW 26505 Andrzej J. Jaworski, M.D., FCCP, D.A.B.S.M.

Phone 304-598-2336 Fax J0.4-598-3717

NAME:

DATE OF BffiTH:

ROME ADDRESS:

BUSINESS ADDRESS:

GRADUATE TRAINING:

PROFESSIONAL EXPERIENCE:

Pulmonary Diseases Critical Cure Sleep Medicine Occuputional Lung Disease

CURRICULUM VITAE

ROGER A. ABRAHAMS, M.D., F.C.C.P.

Morgantown Pulmonary Associates, P.C. & Morgantown Pulmonary Clinical Research 1265 Pineview Drive Morgantown, WV 26505

Fellowship in Pulmonary Medicine Saint Vincent Hospital Major Affiliate: University of Massachusetts Medical School

,..,, c:a Cl"\

:JC > ::0

CJ1

:x:a :JC

'? N \D

1983-1985

Residency in Internal Medicine 1981-1983 Stamford Hospital, Stamford, Connecticut Major Affiliate: New York Medical College Chief Resident: 8/82 - 1/83

Internship in Internal Medicine 1979-1980 Long Island Jewish Medical Center New Hyde Park, NY Major Affiliate: State University of New York at Stonybrook

Private Practice President Morgantown Pulmonary Associates, P.C. 1265 Pineview Drive Morgantown, WV 26505

8/8 7-Present

a

fgo n:E -fC"')

o~ ~o (/) C"l 03'. "'T'I~ ::2 C"') C"l fT1

Clinical Research Morgantown Pulmonary Clinical Research Owner 1265 Pineview Drive Morgantown WV 26505

Speaker for GSK

Clinical Assistant Professor of Medicine West Virginia University Department of Medicine Section of Pulmonary and Critical Care Robert C. Byrd Health Sciences Center Morgantown, WV 26506-9156

NIOSH Certified 8-Reader

1995-Present

2009-2015

7/01-Present

1986-Present

Executive Committee Monongalia General Hospital 1200 J. D. Anderson Drive Morgantown, WV 26505

11/98-10/2009

Chief, Section of Pulmonary Medicine Monongalia General Hospital

President Medical Staff Health South Regional Rehabilitation Hospital 1160 Van Voorhis Road Morgantown, WV 26505

12/00-2010

1/06-1107

Vice President Medical Staff 1/05-1/06 Health South Regional Rehabilitation Hospital

Executive Committee 1994-1998 Health South Regional Rehabilitation Hospital

Chief of Department of Medicine 1/90-1/92 Monongalia General Hospital

Private Practice 4/87-8/87 Pulmonary and Occupational Lung Disease 1197 Van Voorhis Road Morgantown, WV 26505

Medical Director West Virginia Society for Respiratory Therapy, Chapter ll

1987-1988

2

Private Practice Pulmonary and Occupational Lung Disease Internal Medicine Associates, Inc. 99 J. D. Anderson Drive Morgantown, WV 26505

Medical Director Pulmonary Rehabilitation Monongalia General Hospital

Prior to 1986 upon Request

PRESENTATIONS/PUBLICATIONS

(See attachment)

1985-1987

1986-1987

Abstract, ACCP (2014) American College of Chest Physicians -CHEST 2014. Combined Use ofOlodaterol Respimat® and Tiotropium HandiHaler® Shows Additional Lung Function Improvement in COPD Compared with Tiotropium: Results from Two Randomized, Double-blind Studies. Richard ZuWallack, *Lisa Allen, *Gemzel Hernandez-Martinez, *Naitee Ting, Roger Abrahams.

Abstract, ERS (2014) European Respiratory Society - 24th Annual Congress. Safety of once-daily tiotropium and olodaterol fixed­dose combination via the Respimat® in chronic obstructive pulmonary disease in two I-year studies. Roland Buhl, Roger Abrahams, Leif Bjermer, Eric Derom, Matjai Flefar, Jacques Hebert, Antony Veale, *Lars Gronke, *Alan Hamilton, *Kay Tetzlaff *Lawrence Korducki, *Holger Huisman, *Stella Waitere-Wijker, Lorean McGarvey

Abstract, ACCP (2014) American College of Chest Physicians -CHEST 2014. Pooled Safety Analysis of Once-Daily Tiotropium and Olodaterol Fixed-Dose Combination via the Respimat® in Patients with Chronic Obstructive Pulmonary Disease: Two 1-Year Studies. Roland Buhl, Roger Abrahams, Leif Bjermer, Eric Derom, Matjai Flefar, Jacques Hebert, Antony Veale, *Lars Groenke, *Kay Tetzlaff *Lawrence Korducki, *Helger Huisman, *Stella Waitere-Wijker, Lorean McGarvey

3

CLINICAL RESEARCH, PRINCIPAL INVESTIGATOR: Morgantown Pulmonary Clinical Research

Poster, BTS (2014) British Thoracic Society Winter Meeting 2014. Safety of once-daily tiotropium and olodaterol fixed-dose combination via the Respimat in chronic obstructive pulmonary disease in two I-year studies. Roland Buhl, Roger Abrahams, Leif Bjermer, Eric Derom, Matja.z Flezar, Jacques Hebert, Antony Veale, *Lars Groenke, *Alan Hamilton, *Kay Tetzlaff, *Lawrence Korducki, *Holger Huisman, *Stella Waitere-Wijker, Lorean McGarvey

Abstract presentation CHEST 2014, Austin, TX, 10/29/14: Safety of the Combination ofOlodaterol Respimat® and Tiotropium HandiHaler~ Compared with Tiotropium: Results from Two Replicate 12-Week Studies. Roger Abrahams, 1 Lisa Allen,2 Gemzel Hernandez,2 Naitee Ting,2 Richard ZuWallack3

ZuWallack R., Allen L, Hernandez G, Ting N, Abrahams R, Efficacy and safety of combining olodaterol Respimat00 and tiotropium HandiHaler® in patients with COPD: results of two randomized, double-blind, active-controlled studies. /11tematio11al Joumal of Chronic Obstructive P11/11101101y Disease. October 2014, Volume 2014:9, Pages 1133-1144

Oral Abstract presentation at the Asian Pacific Society of Respirology, Hong Kong, China, 12/15/12: Comparison of BEA2/80 to liotropium and placebo via Respirmat in patients with COPD. Roger Abrahams, MD.

Roger Abrahams, Petra Moroni-Zentgraf, Joe Ramsdell, et al. Safety and efficacy of the once-daily anticholinergic BEA2180 compared with tiotropium in patients with COPD. Rejpira101y Medicine. Vol 107, issue 6; June, 2013; p 854-862

2015-Present GSK: "Study MEA 117113: Mepolizumab VS. Placebo as add-on treatment for fequently exacerbating COPD patients characterized by eosinophil level"

2015-Present Boehringer Ingelheim: " A randomised, double­blind, active-controlled parallel group study to elvaluate the effect

4

of 52 weeks of once daily treatment of orally inhled tiotropium ~ olodaterol fixed does combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD. (DYNAGITO) (protocol #1237.19)

2015-Present Pearl: "A Randomized, double-Blind, Multi­Center, Parallel Group Study to Assess the Efficacy and Safety of PTO 10 Relative to PT003 and PT009 on COPD Exacerbation over a 52-week Treatment Period in Subjects With Moderate to Very Severe COPD." (protocol #PT10005-01)

2015-Present Pearl: "A Randomized, Bauble-Blind, Parallel­Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PTO I 0, PT003 and PT009 compared with Symbicort Turbuhaler as and Active Control in subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease." (protocol #PTO 10006-00)

2014-Present AstraZeneca "A randomised, double-blind, double dummy, placebo-controlled, parallel group, multicentre, phase Ill study to evaluate the efficacy and safety of 3 doses of benralizumab (MEDJ-563) in patients with severe to very severe Chronic Obstrutive Pulmonary disease (COPD) with a history of COPD exacerbations" (TERRANOVA) (protocol #03251 C00004)

2014-2015 GSK "A 4-Week Study to Evaluate Four Doses of Umeclidinium Bromide in Combination with Fluticasone Furoate in COPD Subjects with an Asthmatic Component"(protocol # 200699).

2014 Boehringer-lngelheim: "A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat® inhaler) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)" [OTEMT0™2] (protocol# 1237.26).

2013-2014 GSK: "A study to compare the addition of umeclidinium bromide (UMEC) to fluticasone furoate (FF)/vilanterol (VI), with placebo plus FF/VI in subjects with Chronic Obstructive Pulmonary Disease (COPD)" (protocol # 200109).

2012-2014 Coordinating Investigator, Boehringer-Ingelheim:

5

11 A randomize, double-blind, parallel group study to assess efficacy and safety of 12 weeks of once daily treatment of orally inhaled Olodaterol 5 mcg (delivered by the Respimat inhaler) added to tiotropium 18 mcg (delivered by the HandiHaler) compared to placebo (delivered by the Respimat inhaler) added to tiotropium 18 mcg (delivered by the HandiHaler) in patients with chronic obstructive pulmonary disease (COPD)" (protocol #1222.51).

2012- 2013 Forest Research: A phase III, long-tenn, randomize, double blind, extension study of the efficacy, safety and tolerability of2 fixed dose combinations of Aclidinium Bromide/Fonnoterol Fumarate, Aclidinium Bromide, Fonnoterol Fumarate and placebo for 28 weeks treatment in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD)" (protocol #LAC-MD-36).

2012- 2014 Boehringer Ingelheim: "A randomize, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + Olodaterol fixed dose combination (2.5 mcg/5 mcg; 5 mcg/5 mcg) (delivered by the Respimat inhaler) compared with the individual components (2.5 mcg and 5 mcg tiotropium, 5 mcg Olodaterol) (delivered by the Respimat inhaler) in patients with chronic obstructive pulmonary disease (COPD). [TOnado TM 1]11 (protocol #1237.5).

2012 PEARL Therapeutics: "A randomize, double blind, (test products), chronic dosing (7 days), four-period, eight treatment, incomplete block, crossover, multicenter study to assess efficacy and safety of 5 doses of PT 003, one dose of PT 001 and one dose of PT 005 in patients with moderate to severe COPD, compared with Spiriva HandiHaler (tiotropium bromide 18 mcg, open label) as active-controlled" (protocol #PT 003005-00).

2011-2012 Forest Laboratories: "A phase III, randomized, double blind, placebo controlled study evaluating the efficacy, safety, and tolerability of 2 fixed dose combination of Aclidinium Bromide/Fonnoterol Fumarate Compared with Aclidinium Bromide, Formoterol Fumarate and placebo for 24 weeks in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD)" (protocol #LAC-MD-31 ).

2011-2012 GlaxoSmithKline: "A 52 week, multicenter, randomize, double blind, parallel group, placebo controlled study to evaluate the safety and tolerability ofGSK 573719 125 mcg once daily alone and in combination with GW 642444 25 mcg once daily via novel dry powder inhaler (nDPI) in subjects with chronic obstructive pulmonary disease (COPD)" (protocol #DB 2113359).

6

2011-2012 Glaxo SmithKline: 11 A multicenter trial comparing the efficacy and safety ofGSK573719/GW642444 with tiotropium over 24 weeks in subjects with COPD (protocol #DB 211-3374)."

20JO- 2012 GlaxoSmithKline: "A long-tenn safety study of GSK573719 alone and in combination with GW642444 compared with placebo in subjects with COPD (protocol #DB2113359) 11

2009-2010 Boehringer-Ingelheim: "Phase III, one-year, randomized, open-label safety and patient acceptability study of Combivent® Respimat® (ipratropium bromide and albuterol sulfate) (20/100 mcg) Inhalation Spray in comparison to Combivent® Inhalation Aerosol (36/206 mcg) and the free combination of Atrovent® HF A (ipratropium bromide HF A) Inhalation Aerosol (34 mcg) and albuterol HF A inhalation aerosol ( 180 mcg) in adults with chronic obstructive pulmonary disease (COPD) (protocol #BI 1012.62)"

2009-2010 Pifzer: "A Phase 2B, parallel, double blind, double dummy, active comparator and placebo controlled study to investigate the Safety, Toleration and Efficacy of 6-week QD administration of PF-00610355 CRC-749 DPI in patients with moderate COPD (protocol #A 7881013)".

2009-2010 GlaxoSmithKline: "A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared with Placebo in Subjects with Chronic Obstructive Pulmonary Disease (COPD) HZCl 12207".

2009-2010 Boehringer-Ingelheim: 11Randomize, double blind, placebo controlled, parallel group study to assess the efficacy and safety of 48 weeks of once daily treatment of orally inhaled BI 1744 CL (5 mcg [2 actuations of 2.5 mcg] and 10 mcg [2 actuations of 5 mcg]) delivered by the Respimat inhaler, in patients with chronic obstructive pulmonary disease (COPD) (protocol #1222.12)".

2009-2010 Glaxo SmithKline: "A Randomized, Double-Blind, Parallel-Group, 16-Week Study to Evaluate the Effect of Fluticasone Propionate/Salmeterol DISKUS™ 250/50mcg BID and Placebo on Arterial Stiffness in Subjects with Chronic Obstructive Pulmonary Disease (COPD) (protocol #ADCI 12355) ".

2007-2009 GlaxoSmithKline: "A 52-week, Randomized, Double-Blind, Parallel-Group Study ofFluticasone

7

Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 mcg BID and Fluticasone Propionate (FP) DISKUS 250 mcg BID in Treatment of Subjects with Asthma {protocol #ADA109057)11

2007-2009 Coordinating Investigator, Boehringer-Ingelheim: "A multinational, randomized, double-blind, placebo- and active­controlled, parallel group efficacy and safety comparison over 24 weeks of three doses (50 µg, 100 µg, 200 µg) of BEA 2180 to tiotropium 5 µg and placebo delivered by the Respimat® inhaler in patients with chronic obstructive pulmonary disease (COPD) (protocol # 1205. 14 )".

2008-2009 Boehringer-Ingelheim: "Randomize, double blind, parallel group study to assess the efficacy and safety of 4 weeks of once daily treatment of 3 doses of orally inhaled BI 1744CL, each in fixed dose combination with 5 mcg tiotropium bromide (delivered by the Respimat inhaler) compared with 5 mcg tiotropium bromide mono product (delivered by the Respimat inhaler) in patients with COPD (protocol number BI 1237.4)11

2008-2009 GlaxoSmithKline: "A Randomize, Double Blind, Double Dummy, Parallel Group 12 Week Comparison of the Efficacy and Safety of Fluticasone Propionate/Salmeterol Hydrofluoalkane 134 a Metered-Dose Inhaler 230/42 Meg Twice Daily with Fluticasone Propionate/Salmeterol Diskus 250/50 Meg Twice Daily in Subjects with COPD (Protocol #ADC 111117) ".

2007-2008 Boehringer-lngelheim: "A 24 Week (+24 Week Extension), Randomize, Placebo Controlled (Only First 12 Week Period), Double Blind, Parallel Group, Efficacy and Safety Comparison ofTiotropium/Salmeterol (7.5 Mcg/25 Meg) Inhalation Powder in the Morning (PE Capsule Via Tiotropium/Salmeterol HandiHaler), Tiotropium (18 Meg) Inhalation Powder in the Morning (Gelatin Capsule Via Spiriva HandiHaler), Salmeterol Inhalation (25 Meg) Powder in the Morning and Evening (PE Capsule Via Tiotropium/Salmeterol HandiHaler) and Tiotropium/Salmeterol (7.5 Mcg/25 Meg)

Inhalation Powder in the Morning (PE Capsule Via Tiotropium/Salmeterol HandiHaler) Plus Salmeterol (25 Meg) Inhalation Powder in the Evening (PE Capsule Via Tiotropium/Salmeterol HandiHaler) in Patients with COPD (Protocol #1184.15) ".

2007-2008 Novartis: "A 12 Week Treatment, Multicenter, Randomize, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of lndacaterol ( 150 Meg 0. D.) In Patients with Chronic Obstructive Pulmonary Disease (Protocol #CQAB

8

TEACHING APPOINTMENTS:

l 49B 2346) II .

2007 Dey: "A Randomize, Open Label, 2-Way Crossover Trial ofFormoterol Fumarate Inhalation Solution (20 Meg) and Combivent Inhalation Aerosol (lpratropium Bromide 18 Mcg/Albuterol Sulfate 103 Meg) in the Treatment of Patients with Chronic Obstructive Pulmonary Disease (Protocol #201-081 )11

2006-2007 Sepracor: "A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice­Daily, Tiotropium Inhalation Powder Once-Daily, and

Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Inhalation Powder Once-Daily (Dosed Sequentially) in Subjects with Chronic Obstructive Pulmonary Disease."(COPD) (Protocol 091-902).

2006-2007 Boehringer lngelheim: "A comparison of ipratropium bromide/salbutamot delivered by the Respimat® inhaler to COMBIVENT® Inhalation Aerosol and ipratropium bromide delivered by the Respimat® in a 12-week, double-blind, safety and efficacy study in adults with chronic obstructive pulmonary disease." (COPD) (Protocol 1012.56).

2006-2007 Adams: "A Randomized, Double-Blind, Parallel­Group, Multiceneter, Placebo-Controlled Dose-Ranging Study of Erdosteine for the Treatment of Stable Chronic Bronchitis Associated with Chronic Obstructive Pulmonary disease." (Chronic Bronchitis) (Protocol ERD-CB-01-2005).

(Prior Studies Upon Request)

Clinical Assistant Professor Department of Medicine Section of Pulmonary Diseases West Virginia University Medical School Morgantown, WV 26505

Clinical Instructor Department of Medicine Section of Pulmonary Diseases West Virginia University Medical School Morgantown, WV 26505

Visiting Professor Department of Pulmonary Medicine

2001-Present

1987-2001

9/86 & 8/87

9

HONORS/AWARDS:

CERTIFICATIONS:

LICENSURE:

PROFESSIONAL SOCIETIES:

Autonomous University of Guadalajara Medical School, Mexico

Instructor: Department of Medicine 1984-1985 Division of Pulmonary Medicine University of Massachusetts Medical School Worcester, MA

Instructor: Quinsigamond Community College, Department of Respiratory Therapy Worcester, MA

Annual Scientific Essay Contest Long Island Jewish Medical Center and Queens Hospital: Third Prize

"Best Medical Student Award" Class of 1978 Phi Kappa Phi National Honor Society

Blue Key National Honor Society

"WhQ's Who in American Universities and Colleges"

American Board oflntemal Medicine Sub-specialty Board in Pulmonary Diseases

NIOSH Certified 118 11 Reader

American Board of Internal Medicine

Advanced Cardiac Life Support

Federal Licensing Exam - New York

Examination Commission for Foreign Medical Graduates

Pennsylvania West Virginia Massachusetts New York

American Thoracic Society Fellow, American College of Chest Physicians

1984-1985

1979

1978

1973

1973

1973

1988

1986

1983

1980

1979

1977

1988 1985 1984 1979

10

EDUCATION:

Medical:

Pre-Medical:

American College of Physicians West Virginia Thoracic Society West Virginia Medical Society Monongalia County Medical Society Tri State Chest Physicians Association American Medical Association

State University of New York at Stonybrook Queens Hospital Center 5th Pathway

Autonomous University of Guadalajara Mexico; M.D.

Alfred University, NY B.A. Cum Laude - Chemistry

1978-1979

1974-1978

1969-1973

OTHER LANGUAGES: Spanish

PERSONAL INTERESTS:

REFERENCES:

Updated 02-09-2016

Photography: First Place and three honorable mentions in Eastman Kodak and Scholastic Magazine Photography Contest

First Place in New York Coliseum International Photography Show Contest. Scuba Diving Sailing Cycling Backpacking

Available on request

11

Publications--Roger Abrahams, MD, FCCP

ntle Author Type

Roland Buhl, Roger Abrahams, Leif Bjermer, Erle Derom, Matjaf

Safety of once-dallv tlotroplum and olodaterol fixed-dose Flelar, Jacques Hebert, Antony Veale, •tars Groenke, •Alan

combination via the Resplmat in chronic obstructive pulmonary Hamilton, •Kay Tetzlaff, •tawrence Korduckl, *Holger

disease In two 1-year studies Hulsman, •stella Waitere-Wljker, Lorean McGarvey Abstract

Health Status of Patients with COPD Receiving the Combination

of Olodaterol Resplmat• and Tiotroplum HandlHaler• Compared

with Tiotropium: Results from Two Replicate, Randomized, Richard ZuWallack, •usa Allen, •Gemzel Hernandez-Martinez,

Double-Blind Studies *Naltee Ting, Roeer Abrahams Abstract

Combined Use of Olodaterol Resplmat• and Tiotroplum

HandiHaler9 Shows Additional lung Function Improvement In

COPD Compared with Tiotroplum: Results from Two Richard ZuWallack, *Lisa Allen, •Gemzel Hernandez-Martinez,

Randomized, Double-blind Studies *Naltee Ting, Roeer Abrahams Abstract

Safety of the Combination of Olodaterol Resplmat• and

Tlotroplum HandlHaler• Compared with Tlotropium: Results Roger Abrahams, •usa Allen, •Gemzel Hernandez-Martinez,

from Two Replicate 12-Week Studies •Naltee Tlng, Richard ZuWallack Abstract

Roland Buhl, Roger Abrahams, Leif Bjermer, Erle Derom, Matjaf

Pooled Safety Analysis of Once-Dally riotroplum and Olodaterol Flefar, Jacques Hebert, Antony Veale, •tars Groenke, •Kay

Fixed-Dose Combination via the Resplmat• In Patients with Tetzlaff •Lawrence Korduckl, •Holger Hulsman, •stelia Waitere-

Chronic Obstructive Pulmonary Disease: Two l·Year Studies Wljker, Lorean McGarvey Abstract

Roland Buhl, Roger Abrahams, Leif Bjermer, Eric Derom, Matjaf.

Safety of once-dally tlotroplum and olodaterol flxed-dose Flefar, Jacques Hebert, Antony Veale, •tars Groenke, •Alan

combination via the Respimat in chronic obstructive pulmonary Hamilton, •Kay Tetzlaff, •tawrence Korduckl, •Holger

disease In two 1-year studies Hulsman, •stella Waltere-Wljker, Lorean McGarvey Abstract

Analysis of the efficacy and safety of the fixed-dose combination

of tlotroplum + olodaterol In patients with COPD by Initial Stephanie Korn, Roland Buhl, •tars Gronke, •tawrence Korduckl,

disease severity *Valeria c Amato, Gary Ferguson, Roger Abrahams Abstract

Analysis of the efficacy and safety of the fixed-dose combination

of tlotroplum + olodaterol In patients with COPO by previous Stephanie Korn, Roland Buhl, •tars Grenke, •tawrence Korduckl,

usage of Inhaled corticosteroids •valerla C Amato, Gary Ferguson, Roger Abrahams Abstract

Citation

Year Status

2014 Published

2014 Published

2014 Published

2014 Published

2014 Published

2014 Published

2015 Published

2015 Published

Citation Source

European Respiratory Society -

24th Annual Congress

American College of Chest

Physicians - CHEST 2014

American College of Chest

Physicians ·CHEST 2014

American College of Chest

Physicians • CHEST 2014

American College of Chest

Physicians - CHEST 2014

British Thoracic Society Winter

Meeting 2014

Am J Resplf.(;rlt ca~ Med

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Am J Respi~it C:Utalld

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Publications--Roger Abrahams, MD, FCCP

Safety of combining olodaterol Resplmat• and tlotroplum HandiHale~ in African-American patients with COPD: results of pooled data from two randomized, double-blind, active- Roeer Abrahams, •Lisa Allen, •tcay Tetzlaff, *Florian Vo8, Richard American Thoracic Society -controlled studies ZuWallack Abstract 2015 Published llllh International Conference

Tiotropium plus olodaterol fixed-dose combination therapy provides lung function benefits when compared with tiotroplum alone, irrespective of prior treatment with a long-acting Roland Buhl, Roeer Abrahams, •Lars Gronke, •Lawrence bronchodilator: post hoc analyses of two 1-year studies Korducki, Matja! Flefar, Gary T Ferguson Abstract 2015 Published Am J Resplr Crit Care Med

Tiotroplum + olodaterol fixed-dose combination therapy provides lung-function benefits compared with tlotroplum alone in patients with GOLDA/Band C/D chronic obstructive Roland Buhl, Roger Abrahams, •tars Gronke, •Florlan Vo8, pulmonary disease: post hoc analyses of two 1-year studies Matja! Flefar, Gary T Ferguson Abstract 2015 Published Am J Resplr Crlt care Med

Inhaled corticosteroid plus long-acting 82-agonist therapy ls overused in the treatment of patients with chronic obstructive Henrik Watz, Gary T Ferguson, •tars Gronke, *Florian Vo8, R1>1er pulmonary disease: post hoc analyses of two 1-year studies Abrahams, Ronald Buhl Abstract 2015 Published Am J Respir Crlt Care Med

Characteristics of COPD patients with and without maintenance Stephanie Korn, Roger Abrahams, •tars Gronke, •Lawrence treatment at baseline, by GOLD stage: TONADO Korducki, •valerla C Amatto, Roland Buhl Abstract 2015 Published Am J Resplr Crlt Care Med

Michael Chia, Jim Reid, Roland Buhl, Roeer Abrahams, Leif Bjermer, Erle Derom, Matjaf Flefar, Jacques Hebert, Antony

Safety of once-daily tlotroplum and olodaterol fixed-dose Veale, •Lars Groenke, •Afan Hamilton, •Kay Tetzlaff, •Lawrence Thoracic Society of Australia and combination via the Respimat in chronic obstructive pulmonary Korduckl, •Helger Hulsman, •stella Waitere-Wijker, Lorean New Zealand - 2015 Annual disease in two 1-year studies McGarvey Abstract 2015 Published Scientific Meeting

Predictors of response to treatment from two randomized, double-blind, active-controlled studies combining olodaterol Roger Abrahams, •usa Allen, *Emmanuelle Clerlsme-Beaty, American Thorade Society -Respimat• and tiotroplum HandiHaler• In patients with COPD •Naltee Ting, Richard ZuWallack Abstract 2015 Published lllth International Conference

Dave Singh, Gary T. Ferguson, Josef Bolltschek, •tars Gronke, • Tiotroplum + olodaterol fixed-dose combination shows clinically Christoph Hallmann, •Nathan Bennett, Roeer Abrahams, Olaf European Respiratory Society -meaningful Improvements ln quality of life vs placebo Schmidt, Leif Bjermer Abstract 2015 Published 25th Annual Congress

American Association of Nurse Efficacy and safety of once-dally tlotroplum and olodaterol fixed- Practitioners - 2015 National dose combination via Resplmat• 1n COPD Chris Garvey, Roeer Abrahams, Lars Groenke•, Gary Ferguson Abstract 2015 Presented Conference

Tiotropium + Olodaterol Provides Improvements in SGRQ and Gary T. Ferguson; •Emmanuelle Clermise-Beaty; •Lars Gronke; Dyspnea Compared with Monotherapy Components In Patients •Florian VoB; •Lawrence Korduckl; •Nathan Bennett; Roger American College of Chest with COPD: Results from Four Randomized, Double-Bllnd Studies Abrahams Abstract 2015 Published Physicians - CHEST 2015

Publications--Roger Abrahams, MD, FCCP

Effect of Tlotroplum + Olodaterol on the Use of NlghtTime Racer Abrahams; Gary T. Ferguson; •Emmanuelle Clermlse-Rescue Medication in Patients with COPD: Results from Four Beaty,• Lars Gr6nke; •Florian VoB; •Lawrence Korduckl; •Nathan American College of Chest

Randomized, Double-Bllnd Studies Bennett; Roland Buhl Abstract 2015 Published Physicians ·CHEST 2015

Roland Buhl, Roeer Abrahams, Leif Bjermer, Eric Derom, Matja.i Deutsche Gesellschaft fur Safety of once-dally tiotroplum and olodaterol fixed-dose Flefar, Jacques Hebert, Antony Veale, •Lars Gronke, •Alan Pneumologie und combination via the Respimat• In chronic obstructive pulmonary Hamllton, •Kay Tetzlaff, •Lawrence Korduckl, •Holger Huisman, Beatmungsmedizln • 56th disease In two 1-year studies •stella Waltere-Wljker, Lorean McGarvey Abstract 2015 Published Kongress

Characteristics of COPD patients with and without maintenance Stephanie Korn, RoCer Abrahams, •Lars Gronke, •Lawrence British Thoracic Society Winter treatment at baseline, by GOLD stage: TONADO Korduckl, •valeria C Amatto, Roland Buhl Abstract 2015 Published Meeting 2015

Analysis of the efficacy and safety of the fixed-dose combination of tlotroplum + olodaterol in patients with COPD by previous Stephanie Korn, Roland Buhl, •Lars Gronke, •Lawrence Korducki, British Thoracic Society Winter usage of Inhaled corticosteroids •valeria C Amato, Gary Ferguson, Racer Abrahams Abstract 2015 Published Meeting 2015

Inhaled corticosteroid plus long-acting R2-agonlst therapy Is overused In the treatment of patients with chronic obstructive Henrik Watz, Gary T Ferguson, •Lars Gronke, •Florian VoB, RoCer British Thoracic Society Winter pulmonary disease: post hoc analyses of two 1-year studies Abrahams, Ronald Buhl Abstract 2015 Published Meeting 2015

Tlotropium plus olodaterol fixed-dose combination therapy provides lung function benefits when compared with tiotroplum alone, Irrespective of prior treatment with a long-acting Roland Buhl, Roger Abrahams, •Lars Gronke, •Lawrence British Thoracic Society Winter bronchodilator: post hoc analyses of two l·year studies Korduckl, Matjal Flefar, Gary T Ferguson Abstract 2015 Published Meeting 2015

R Buhl, F Maltais, R Abrahams, L Bjermer, E Derom, G Ferguson, M Flefar, J Hebert, L McGarvey, E Plzzichini, J Reid, A Veale, •L

Tlotroplum and olodaterol fixed-dose combination versus mono- Gronke, •A Hamilton, •t Korduckl, •K Tetzlaff, •s Waltere-Wljker, Primary components In COPD (GOLD 2-4) H Watz, E Bateman Manuscript 2015 Published Eur Resplr J

Efficacy and safety of combining olodaterol Resplmat• and tiotroplum Hand1Haler9 in patients with COPD: results of two Richard ZuWallack, •usa Allen, •Gemzel Hernandez- Primary randomized, double-blind, active-controlled studies Martinez, •Naltee Ting, Racer Abrahams Manuscript 2014 Published Int J Chron Obstruct Pulmon Dis

Dave Singh, Gary T Ferguson, Josef Bolltschek, •Lars Gronke, Tlotroplum + olodaterol shows cllnlcally meaningful •chrlstoph Hallman, •Nathan Bennett, Roeer Abrahams, Olaf Primary improvements In quality of life Schmidt, Leif Bjermer Manuscript 2015 Published ResplrMed

Efficacy and safety of lpratroplum bromide/albuteroll inhaled via ZuWallack R, De Salvo M, Kaelin T, Bateman E, Parle C, Abrahams Primary Resplmat(R) or MDI R, Faisal F, Sachs P, Pudi K, •zhao V, •wood C Manuscript 2010 Completed RespirMed

Publications--Roger Abrahams, MD, FCCP

Efficacy of Tiotroplum + Olodaterol in Patients with Chronic

Obstructive Pulmonary Disease by Initial Disease Severity and Ferguson GT, Flezar M, Korn S, •Korduckl L, •Groenke L, Secondary

Treatment Intensity: A Post Hoc Analysis Abrahams R, Buhl R Manuscript 2015 Published AdvTher

Roland Buhl, Roter Abrahams, Leif Bjermer, Eric Derom, Matjaf

Safety of once-dally tiotropium and olodaterol fixed-dose Fleiar, Jacques Hebert, Antony Veale, •tars Groenke, •Alan

combination via the Respimat in chronic obstructive pulmonary Hamilton, •Kay Tetzlaff, •tawrence Korduckl, •Holger European Respiratory Society·

disease In two !·year studies Hulsman, •stella Waitere·Wijker, Lorean McGarvey Poster 2014 Presented 24th Annual Congress

Safety of the Combination of Olodaterol Resplmat• and

Tiotroplum HandlHaler• Compared with Tiotroplum: Results Roger Abrahams, •usa Allen, •Gemzel Hernandez-Martinez, American College of Chest from Two Replicate 12-Week Studies *Naltee Ting, Richard ZuWallack Poster 2014 Presented Physicians· CHEST 2014

Health Status of Patients with COPD Receiving the Combination

of Olodaterol Respimat• and Tiotropium Hand1Haler9 Compared

with Tiotropium: Results from Two Replicate, Randomized, Richard ZuWallack, *Lisa Allen, •Gemzel Hernandez-Martinez, American College of Chest Double-Blind Studies •Naitee Ting, Roger Abrahams Poster 2014 Presented Physicians - CHEST 2014

Roland Buhl, Roter Abrahams, Leif Bjermer, Eric Derom, Matjaf

Pooled Safety Analysis of Once-Dally Tiotroplum and Olodaterol Fleiar, Jacques Hebert, Antony Veale, •tars Groenke, •Kay

Fixed-Dose Combination via the Resplmat• in Patients with Tetzlaff •tawrence Korducki, •Holger Huisman, •stella Waltere- American College of Chest

Chronic Obstructive Pulmonary Disease: Two l·Year Studies Wijker, Lorean McGarvey Poster 2014 Presented Physicians ·CHEST 2014

Roland Buhl, R0&er Abrahams, Leif Bjermer, Eric Derom, Matjaf

Safety of once-dally tlotroplum and olodaterol fixed-dose Flefar, Jacques Hebert, Antony Veale, •tars Grenke, •Alan

combination via the Respimat• In chronic obstructive pulmonary Hamilton, *Kay Tetzlaff *Lawrence Korducki, *Holger Hulsman, British Thoracic Society Winter disease In two 1-year studies •stella Waltere-Wijker, Lorean McGarvey Poster 2014 Presented Meeting 2014 Analysis of the efficacy and safety of the fixed-dose comb I nation

of tiotropium + olodaterol in patients with COPO by initial Stephanie Korn, Roland Buhl, •tars Gronke, *Lawrence Korducki, American Thoracic Society -disease severity *Valeria C Amato, Gary Ferguson, Roger Abrahams Poster 2015 Presented 111th International Conference

Analysis of the efficacy and safety of the fixed-dose combination

of tlotroplum + olodaterol in patients with COPD by previous Stephanie Korn, Roland Buhl, •tars Gronke, •tawrence Korducki, American Thoracic Society -usage of Inhaled corticosteroids *Valeria C Amato, Gary Ferguson, Roter Abrahams Poster 2015 Presented 111th International Conference

Tiotroplum + olodaterol fixed-dose combination therapy

provides lung function benefits when compared with tlotropium

alone, Irrespective of prior treatment with a long-acting Roland Buhl, Roger Abrahams, •tars Gronke, *Lawrence American Thoracic Society -bronchodllatbr: post hoc analyses of two l·year studies Korduckl, Matjaf Flefar, Gary T Ferguson Poster 2015 Presented lllth International Conference

Publications--Roger Abrahams, MD, FCCP

Tlotroplum + olodaterol fixed-dose combination therapy provides lung-function benefits compared with tiotropium alone In patients with GOLD A/B and C/D chronic obstructive Roland Buhl, Roger Abrahams, *Lars Gronke, • Florian VoB, American Thoracic Society • pulmonary disease: post hoc analyses of two l·year studies Matjaf Flefar, Gary T Ferguson Poster 2015 Presented lllth International Conference

Inhaled corticosteroid plus long-acting 1!2-agonlst therapy Is overused in the treatment of patients with chronic obstructive Henrik Watz, Gary T Ferguson, *Lars Gronke, •Florian VoB, Roeer American Thoracic Society • pulmonary disease: post hoc analyses of two 1-year studies Abrahams, Ronald Buhl Poster 2015 Presented lllth International Conference

Characteristics of COPD patients with and without maintenance Stephanie Korn, Roeer Abrahams, *Lars Gronke, *Lawrence American Thoracic Society· treatment at baseline, by GOLD stage: TONADO Korducki, *Valeria c Amatto, Roland Buhl Poster 2015 Presented lllth International Conference

Michael Chia, Roland Buhl, Roeer Abrahams, Leif Bjermer, Erle safety of once-dally tiotropium and olodaterol fixed-dose Derom, Matjaf Flefar, Jacques Hebert, Antony Veale, •Lars Thoracic Society of Australia and combination via the Respimat In chronic obstructive pulmonary Groenke, •Alan Hamllton, •Kay Tetzlaff, •Lawrence Korduckl, New Zealand • 2015 Annual disease In two 1-year studies •Holger Hulsman, •stella Waltere·Wljker, Lorean McGarvey Poster 2015 Presented Scientific Meeting

Safety of combining olodaterol Resplmat• and tlotroplum HandiHaler• in African-American patients with COPD: results of pooled data from two randomized, double-blind, active- Roeer Abrahams, •lfsa Allen, •Kay Tetzlaff, •Florian VoB, Richard American Thoracic Society· controlled studies ZuWallack Poster 2015 Presented lllth International Conference

Predictors of response to treatment from two randomized, double-blind, active-controlled studies combining olodaterol Roeer Abrahams, •usa Allen, •Emmanuelle Clerlsme·Beaty, American Thoracic Society -Respimat• and tlotroplum HandiHaler• In patients with COPD •Naltee Ting, Richard ZuWallack Poster 2015 Presented lllth International Conference

Roland Buhl, Roeer Abrah1ms, Leif Bjermer, Eric Oerom, Matjaf Deutsche Gesellschaft fur Safety of once-dally tiotroplum and olodaterol fixed-dose Flefar, Jacques Hebert, Antony Veale, •Lars Gronke, •Alan Pneumologle und combination via the Respimat• In chronic obstructive pulmonary Hamilton, •Kay Tetzlaff, •Lawrence Korduckl, •Holger Hulsman, Beatmungsmedlzln • 56th disease In two 1-year studies •stella Waltere-Wljker, Lorean McGarvey Poster 2015 Presented Kongress

American Association of Nurse Efficacy and safety of once-dally tlotroplum and olodaterol fixed- Practitioners - 2015 National dose combination via Resplmat• In COPO Chris Garvey, Roeer Abrahams, Lars Groenke•, Gary Ferguson Poster 2015 Presented Conference

Dave Singh, Gary T Ferguson, Josef Bolitschek, •Lars Gronke, Tlotroplum + olodaterol fixed-dose combination shows clinically •chrlstoph Hallmann, •Nathan Bennett, Ro1er Abrahams, Olaf European Respiratory Society • meaningful Improvements In quality of life versus placebo Schmidt, Leif Bjermer Poster 2015 Presented 25th Annual Congress

Tlotroplum + Olodaterol Provides Improvements in SGRQ and Dyspnea Compared with Monotherapy Components In Patients Gary T. Ferguson; •emmanuelle Clermlse-Beaty; •Lars Gronke; American College of Chest with COPD: Results from Four Randomized, Double-Blind Studies •Florian Vo8; •Nathan Bennett; Roeer Abrahams Poster 2015 Presented Physicians • CHEST 2015

Publications--Roger Abrahams, MD, FCCP

Effect ofTJotropium + Olodaterol on the Use of Night-Time Raser Abrahams; Gary T. Ferguson; •Emmanuelle Clermlse-

Rescue Medication in Patients with COPD: Results from Four Beaty,• Lars Gronke; •Florian VoB; •Lawrence Korducki; •Nathan American College of Chest

Randomized, Double-Blind Studies Bennett; Roland Buhl Poster 2015 Presented Physicians· CHEST 2015

Characteristics of COPD patients with and without maintenance Stephanie Korn, Roter Abrahams, Lars Gronke, Lawrence British Thoracic Society Winter

treatment at baseline, by GOLD stage: TONADO Korducki, Valeria C Amatto, Roland Buhl Poster 2015 Presented Meeting 2015

Inhaled corticosteroid plus long-acting 82-agonist therapy Is

overused In the treatment of patients with chronic obstructive Henrik Watz, Gary T Ferguson, Lars Gronke, Florian VoB, Roger British Thoracic Society Winter

pulmonary disease: post hoc analyses of two 1-year studies Abrahams, Ronald Buhl Poster 2015 Presented Meeting 2015

Tlotroplum plus olodaterol fixed-dose combination therapy

provides lung function benefits when compared with tlotroplum

alone, Irrespective of prior treatment with a long-acting Roland Buhl, Rcser Abrahams, Lars GrOnke, Lawrence Korduckl, British Thoracic Society Winter

bronchodilator: post hoc analyses of two 1-year studies Matjaf Flefar, Gary T Ferguson Poster 2015 Presented Meeting 2015

Characteristics of COPD patients with and without maintenance Stephanie Korn, RD1er Abrahams, Lars Gronke, Lawrence British Thoracic Society Winter

treatment at baseline, by GOLD stage: TONADO Korduckl, Valeria C Amatto, Roland Buhl Poster 2015 Presented Meeting 2015

Inhaled corticosteroid plus long-acting 82-agonlst therapy Is

overused In the treatment of patients with chronic obstructive Henrik Watz, Gary T Ferguson, Lars Gronke, Florian VoB, Raser British Thoracic Society Winter

pulmonary disease: post hoc analyses of two 1-year studies Abrahams, Ronald Buhl Poster 2015 Presented Meeting 2015

Tlotropium plus olodaterol fixed-dose combination therapy

provides lung function benefits when compared with tlotroplum

alone, Irrespective of prior treatment with a long-acting Roland Buhl, Ro1er Abrahams, Lars Gronke, Lawrence Korduckl, British Thoracic Society Winter bronchodilator: post hoc analyses of two l ·year studies Matjaf Flefar, Gary T Ferguson Poster 2015 Presented Meeting 2015

Combined Use of Olodaterol Resplmat• and Tlotropium

HandiHalei4 Shows Additional lung Function Improvement in

COPD Compared with Tlotroplum: Results from Two Richard ZuWallack, •Lisa Allen, •Gemzel Hernandez-Martinez, American College of Chest Randomized, Double-blind Studies •Naltee Ting. Raser Abrahams Presentation 2014 Presented Physicians ·CHEST 2014

Analysis of the efficacy and safety of the fixed-dose combination Lorean McGarvey, Stephanie Korn, Roland Buhl, •Lars Groenke,

of tiotropium + olodaterol In patients with COPD by previous •Lawrence Korduckl, •Valeria C Amatto, Gary T Ferguson, Roger British Thoracic Society Winter usage of Inhaled corticosteroids Abrahams Presentation 2015 Presented Meeting 2015