26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

2,059

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

Conditions
Pulmonary Disease, Chronic ObstructiveCOPDLung Diseases, Obstructive
Interventions
DRUG

Indacaterol

In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).

DRUG

Formoterol (12 µg b.i.d.)

Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.

DRUG

Tiotropium (18 µg o.d.)

Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.

DRUG

Placebo to Indacaterol

In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).

DRUG

Placebo to Formoterol

In the morning and in the evening, placebo to formoterol delivered via Aerolizer.

Trial Locations (344)

716

Novartis Investigator Site, Ponce

7101

Novartis Investigator Site, Newark

10016

New York Pulmonary Associates, PC, New York

10021

Weill Medical College of Cornell University, New York

10029

Mount Sinai Medical Center, New York

11040

North Shore University Hospital, New Hyde Park

11102

Crescent Medical Associates, Astoria

11758

Nassau Chest Physicians, PC, Massapequa

12205

Pulmonary and Critical Care Services, Albany

13045

Asthma and Allergy Associates, Cortland

14618

AAIR research Centre, Rochester

14905

Asthma and Allergy Associates, Elmira

15025

Pittsburgh Pulmonary Associates, Pittsburgh

15243

South Hills Pulmonary Associates, Pittsburgh

16506

Chest Diseases of Northwestern PA, Erie

18045

Novartis Investigator Site, Easton

19107

Asthma Allergy &Pulmonary Associates, PC, Philadelphia

Drexel University College of Medicine, Philadelphia

19140

Novartis Investigator Site, Philadelphia

19141

Novartis Investigator Site, Philadelphia

19713

Lung Health & Sleep Enhancement Center, Newark

21224

John Hopkins Asthma and Allergy Center, Baltimore

22908

University of Virginia, Charlottesville

23249

Novartis Investigator Site, Richmond

24210

Johnston Memorial Hospital Pulmonary Research, Abingdon

24501

Lynchburg Pulmonary Associates, Lynchburg

26304

Charleston Area Medical Center, Charleston

27103

Cloverdale Research Facility, Winston-Salem

27599

University of North Carolina, Chapel Hill

27607

North Carolina Clinical Research, Raleigh

28150

Novartis Investigator Site, Shelby

28277

Sensenbrenner Primary Care, Charlotte

29303

Spartanburg Pharmaceutical Research, Spartanburg

29412

Hugh D. Durrence, MD, Family Medicine, Charleston

29425

Medical University of South Carolina, Charleston

29576

Med Plus South - Strand Family Practice, Garden City

29615

Novartis Investigator Site, Greenville

29944

Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab, Varnville

30060

Marietta Pulmonary Medicine, Marietta

30106

Georgia Clinical Research, Austell

30342

Neutrotrials Research Inc, Atlanta

32209

Shands Jacksonville Medical Center, Jacksonville

32504

Emerald Coast Clinical Research, LLC, Pensacola

Pensacola Research Consultants, Pensacola

32514

Integrity Research, Pensacola

32955

Brevard Pulmonary Specialists, Rockledge

33029

Novartis Investigator Site, Pembroke Pines

33136

University of Miami School of Medicine, Miami

33143

South Miami Clinical Research, LLC, South Miami

33169

Elite Research Institute, Miami

33321

Central Medical Group, PA, Tamarac

Clireco, Inc, Tamarac

33603

Novartis Investigator Site, Tampa

33613

University of South Florida, Tampa

33765

Clinical Research of West Florida, Clearwater

33770

Innovative Research of West Florida, Largo

34233

Asthma & Allergy Research Center, Sarasota

35209

Pulmonary Medicine Associates PC, Homewood

35249

University of Alabama at Birmingham, Birmingham

35501

Jasper Summit Research, Jasper

36207

Pinnacle Research Group, LLC, Anniston

36608

Pulmonary Associate of Mobile, PC, Mobile

37203

Dickson Family Medicine Group, PC, Nashville

37601

MultiSpeciality Clinical Research, Johnson City

37660

Holston Medical Group, Kingsport

37920

Volunteer Research Center, Knoxville

40215

Family Asthma and Allergy Research Associates, Louisville

40504

Kentucky Medical research Center, Lexington

40536

University of Kentucky Chandler Medical Center, Lexington

41017

Novartis Investigator Site, Crescent Springs

43076

Advanced Health Care Specialists, Thornville

43210

Ohio State University - Davis Heart and Lung Research Institute, Columbus

43213

Novartis Investigator Site, Columbus

43215

Remington-Davis Clinical Research, Columbus

43235

Novartis Investigator Site, Columbus

43302

Novartis Investigator Site, Marion

43614

The University of Toledo, Toledo

43650

John Winder Associates, Sylvania

43701

Pharmacotherapy Research Associates, Inc, Zanesville

44106

University Hospitals of Cleveland, Cleveland

44195

Cleveland Clinic, Cleveland

45220

Cincinnati VA Hospital, Cincinnati

45231

Bernstein Clinical Research Centre, Cincinnati

45245

Community Research Inc, Cincinnati

46011

Community Hospital Anderson, Anderson

46256

Dawes Fretzin Clinical Research Group LLC, Indianapolis

46617

South Bend Clinic, South Bend

48060

Novartis Investigator Site, Port Huron

48085

Novartis Investigator Site, Troy

48152

Pulmonary Respiratory Institute of Southwest Michigan, Livonia

48201

Harper University Hospital; Wayne State University, Detroit

48346

Novartis Investigator Site, Clarkston

48532

Novartis Investigator Site, Flint

52240

Iowa Clinical Research Corporation, Iowa City

52242

University of Iowa, Iowa City

53209

Novartis Investigator Site, Milwaukee

55402

Clinical Research Institute, Minneapolis

Novartis Investigator Site, Minneapolis

55407

Minnesota Lung Center, Minneapolis

55435

Minnesota Lung Center, Edina

55905

Mayo Clinic, Rochester

58122

Merit Care Medical Group, Fargo

59102

Montana Health Research Institute, Billings

59808

Novartis Investigator Site, Missoula

59901

Novartis Investigator Site, Kalispell

60305

Novartis Investigator Site, River Forest

60637

University of Chicago Hospital, Chicago

61761

Sneeze, Wheeze & Itch Associates, LLC, Normal

62269

Southern Illinois Clinical Research Center, O'Fallon

63017

St. Luke's Cardio-Pulmonary Research, Chesterfield

63110

Washington U School of Medicine, Center for Clinical Studies, St Louis

63141

The Clinical Research Centre, St Louis

63301

Midwest Chest Consultants, Saint Charles

65212

University of Missouri - Columbia, Columbia

66216

Heart of America Research Institute, Shawnee Mission

66606

Cotton-O'Neil Clinical Research Center, Topeka

68046

The Asthma & Allergy Center, PC, Papillion

68105

Omaha VA Medical Center, Omaha

68114

Quality Clinical Research, Omaha

68130

Midwest Allergy and Asthma Clinic, Omaha

68131

Creighton University Centre for Allergy, Asthma & Immunology, Omaha

Creigton University, Omaha

68134

Heartland Clinical Research, Inc, Omaha

Meridian Clinical Research, LLC, Omaha

68510

Somnos Laboratories, Inc, Lincoln

70002

Rx R&D, Metaire

70112

LSU Health Sciences Center/LSU School of Medicine, New Orleans

70119

New Orleans Center for Clinical Research, New Orleans

70461

Northshore Research Associates, Slidell

70503

Gulf Coast Research, LLC, Lafayette

71103

Louisiana Health Sciences Center, Shreveport

71603

Novartis Investigator Site, Pine Bluff

73104

Oklahoma Allergy and Asthma Clinic, Oklahoma City

University of Oklahoma Health Science Center, Oklahoma City

73112

Lynne Health Science Institute, Oklahoma City

74135

Healthcare Research Consultants, Inc, Tulsa

75110

Trinity Clinic - Corsicana, Corsicana

75231

Asthma & Allergy Research Associates, Dallas

76104

Texas Pulmonary & Critical Care, Fort Worth

77024

*Private Practice*, Houston

77030

Baylor College of Medicine, Houston

Houstons Veteran's Medical Center, Houston

77450

West Houston Allergy and Asthma, PA, Katy

78130

Central Texas Health Research, New Braunfels

78205

Quality Assurance Research Centre, San Antonio

78229

Allergy and Asthma Research Center, PA, San Antonio

Diagnostics Research Group, San Antonio

Wellmed Clinical Research, San Antonio

79106

PharmaTex Research LLC, Amarillo

79902

Western Sky Medical Research, El Paso

80033

Rocky Mountain Center for Clinical Research, Wheat Ridge

Western States Clinical Research, Wheat Ridge

80206

National Jewish Medical & Research Center, Denver

80304

Boulder Medical Center, Boulder

80401

New West Physicians Clinical research, Golden

80528

Northern Colorado Pulmonary Consultants, PC, Fort Collins

85006

Pulmonary Associates, PA, Phoenix

85255

Novartis Investigative Center, Scottsdale

85258

Arizona Pulmonary Specialists, LTD, Scottsdale

85282

Premiere Pharmaceutical Research, LLC, Tempe

85306

Pulmonary Associates, PA, Glendale

85712

Canyon Clinical Research, LLC, Tucson

85723

SAVAHSC / Pulmonary Section, Tucson

89014

Lovelace Scientific Resources, Inc., Henderson

89131

Clinical Research Center of NV, Las Vegas

90025

Allergy Research Foundation, Inc, Los Angeles

90033

Novartis Investigator Site, Los Angeles

90048

Southern California Institute for Respiratory Diseases, Los Angeles

90095

David Geffen UCLA School of Medicine, Los Angeles

90242

USC Rancho Amigos Medical Center, Downey

90505

Peninsula Pulmonary Medical Associates, Torrance

90620

Novartis Investigator Site, Buena Park

90720

Interlink Research Institute, Los Alamitos

91343

Greater Los Angeles Healthcare System, Sepulveda

91978

Encompass Clinical Research, Spring Valley

92024

Encompass Clinical Research - North Coast, Encinitas

92083

Progressive Clinical Research, Vista

92506

Intergrated Research Group, Riverside

92647

Allergy and Asthma Specialists Medical Group and research Center, Huntington Beach

92835

California Research, Fullerton

92869

Advance Clinical Research Institute, Orange

93551

California Allergy & Asthma Medical Group, Palmdale

94598

Allergy and Asthma Clinical Research Inc, Walnut Creek

95117

Allergy & Asthma Associates of Santa Clara Res. Center, San Jose

95207

Bensch Clinical Research Associates, Stockton

97213

Allergy Associates Research Center, Portland

97404

River Road Medical Group, Eugene

97504

Clinical Research Institute of Southern Oregon, PC, Medford

Oregon Clinical Research Associates, Medford

98226

Madrona Medical Group - Clinical Research Dept., Bellingham

98405

Pulmonary Consultants, PLLC, Tacoma

98431

Madigan Army medical Center / Dept. of Army, Tacoma

99204

Pulmonary and Research Associates, Spokane

99216

William L. Gray Research, Spokane

452242

New Horizons Clinical Research, Cincinnati

06856

Norwalk Hospital, Norwalk

32610 - 0277

University of Florida Shands Hospital, Gainesville

04401

Allergy, Asthma, Immunology, Pharmaceutical Studies, Bangor

04005

Primecare Physician Associates, Biddeford

02302

Miray Medical Center, Brockton

01604

Fallon Clinic at Worcester Medical Center, Worcester

48106-0525

ClinSite, Inc, Ann Arbor

48602 - 5303

Synergy Medical Education Alliance, Saginaw

64106 - 1453

Kansas City University of Medicine and Biosciences, Kansas City

64108-2677

University of Missouri KC/ Truman Medical, Kansas City

68198 - 5885

University of Nebraska Medical Center - Pulmonary Research, Omaha

03756

Dartmouth Hitchcock Medical Center, Lebanon

08003

Delaware Valley Clinical Research, Cherry Hill

08816

Pulmonary and Critical Care Associates, PA, East Brunswick

07901

Pulmonary and Allergy Associates, PA, Summit

44109-1998

Metro Health Medical Center, Cleveland

97227-1110

Novartis Investigator Site, Portland

15009 - 1957

Tri-State Medical Group, Beaver

02920

New England Center for Clinical Research, Cranston

02864

Partners in Clinical Research, Cumberland

29406-7108

Low County Lung and Critical Care, PA, Charleston

37208-3599

Novartis Investigator Site, Nashville

37825-1409

Heartland Medical, P.C, New Tazewell

75231-4307

Pharmaceutical Research & Consulting, Inc, Dallas

77555 - 0561

University of Texas Medical Branch at Galveston, Galveston

78229 - 4404

Audie L. Murphy VA Hospital, San Antonio

05446

Vermont Lung Center, Colchester

Unknown

Novartis Investigator Site, Buenos Aires

Novartis, Buenos Aires

Novartis Investigator Site, Capital Federal

Novartis Investigator Site, Santa Fe

Novartis Investigator Site, Ajax

Novartis Investigator Site, Calgary

Novartis Investigator Site, Chatham

Novartis Investigator Site, Gatineau

Novartis Investigator Site, Moncton

Novartis Investigator Site, Montreal

Novartis Investigator Site, Niagara Falls

Novartis Investigator Site, Ottawa

Novartis, Québec

Novartis Investigator Site, Saint Romuald

Novartis Investigator Site, Saskatoon

Novartis Investigator Site, Sherbrooke

Novartis Investigator Site, St. John's

Novartis Investigator Site, Ste-Foy

Novartis Investigator Site, Toronto

Novartis Investigator Site, Trois-Rivières

Novartis Investigator Site, Vancouver

Novartis Investigator Site, Waterloo

Novartis Investigator Site, Windsor

Novartis Investigator Site, Winnipeg

Novartis Investigator Site, Augsburg

Novartis Investigator Site, Bad Segeberg

Novartis Investigator Site, Berlin

Novartis Investigator Site, Bielefeld

Novartis Investigator Site, Bonn

Novartis Investigator Site, Brühl

Novartis Investigator Site, Dachau

Novartis, Fürth

Novartis Investigator Site, Hamburg

Novartis Investigator Site, Hoyerswerda

Novartis Investigator Site, Kaufbeuren

Novartis Investigator Site, Landsberg

Novartis Investigator Site, Leipzig

Novartis Investigator Site, Mainz

Novartis Investigator Site, München

Novartis Investigator Site, Oranienburg

Novartis Investigator Site, Oschersleben

Novartis Investigator Site, Potsdam

Novartis Investigator Site, Ratingen

Novartis Investigator Site, Steinfurt

Novartis Investigator Site, Wuppertal

Novartis Investigator Site, Bangalore

Novartis Investigator Site, Banglore

Novartis Investigator Site, Caranazalem

Novartis Investigator Site, Chennai

Novartis Investigator Site, Coimbatore

Novartis Investigator Site, Hyderabaad

Novartis Investigator Site, Indore

Novartis Investigator Site, Jaipur

Novartis Investigator Site, Kolkata

Novartis Investigator Site, Ludhiana

Novartis Investigator Site, Mumbai

Novartis Investigator Site, Trivandrum

Novartis Investigator Site, Bologna

Novartis Investigator Site, Busto Arsizio

Novartis Investigator Site, Catania

Novartis Investigator Site, Catanzaro

Novartis Investigator Site, Chioggia

Novartis Investigator Site, Crema

Novartis Investigator Site, Ferrara

Novartis Investigator Site, Florence

Novartis Investigator Site, Genova

Novartis Investigator Site, Messina

Novartis Investigator Site, Milan

Novartis, Milan

Novartis Investigator Site, Pisa

Novartis Investigator Site, Roma

Novartis Investigator Site, Rozzano

Novartis Investigator Site, Siena

Novartis Investigator Site, Bucheon-si

Novartis Investigator Site, Busan

Novartis Investigator Site, Chuncheon

Novartis Investigator Site, Daegu

Novartis Investigator Site, Kwangju

Novartis Investigator Site, Seoul

Novartis, Seoul

Novartis Investigator Site, Suwon

Novartis Investigator Site, Wŏnju

Novartis Investigator Site, A Coruña

Novartis Investigator Site, Alicante

Novartis Investigator Site, Barcelona

Novartis, Barcelona

Novartis Investigator Site, Burgos

Novartis Investigator Site, Cadiz

Novartis Investigator Site, Calde Lugo

Novartis Investigator Site, Galdakano

Novartis Investigator Site, Girona

Novartis Investigator Site, Gran Canaria

Novartis Investigator Site, Madrid

Novartis Investigator Site, Málaga

Novartis Investigator Site, Ourense

Novartis Investigator Site, Oviedo

Novartis Investigator Site, Palma de Mallorca

Novartis Investigator Site, Ponferrada

Novartis Investigator Site, Pontevedra

Novartis Investigator Site, Port de Sagunt

Novartis Investigator Site, Seville

Novartis Investigator Site, Valencia

Novartis Investigator Site, Vic

Novartis Investigator Site, Vila-real

Novartis Investigator Site, Zaragoza

Novartis, Gothenburg

Novartis Investigator Site, Jönköping

Novartis Investigator Site, Lidingö

Novartis Investigator Site, Luleå

Novartis Investigator Site, Lund

Novartis Investigator Site, Chiayi City

Novartis Investigator Site, Linkou District

Novartis Investigator Site, Taichung

Novartis Investigator Site, Taipei

Novartis, Taipei

Novartis Investigator Site, Ankara

Novartis, Istanbul

Novartis Investigator Site, Izmir

Novartis Investigator Site, Konya

Novartis Investigator Site, Manisa

Novartis Investigator Site, Mersin

Novartis Investigator Site, Yenişehir

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