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

NCT ID: NCT00463567

Last Updated: 2011-08-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2059 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-08-31

Brief Summary

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Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive COPD Lung Diseases, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Indacaterol 150 µg (Continued Into Stage 2)

In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.

Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

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

Placebo to Indacaterol

Intervention Type DRUG

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

Placebo to Formoterol

Intervention Type DRUG

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

Indacaterol 300 µg (Continued Into Stage 2)

In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.

Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

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

Placebo to Indacaterol

Intervention Type DRUG

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

Placebo to Formoterol

Intervention Type DRUG

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

Tiotropium 18 µg (Continued Into Stage 2)

Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.

Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

Group Type ACTIVE_COMPARATOR

Tiotropium (18 µg o.d.)

Intervention Type DRUG

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

Placebo (Continued Into Stage 2)

In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.

Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

Group Type PLACEBO_COMPARATOR

Placebo to Indacaterol

Intervention Type DRUG

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

Placebo to Formoterol

Intervention Type DRUG

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

Indacaterol 75 µg (Not Continued into Stage 2)

In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.

Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

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

Placebo to Indacaterol

Intervention Type DRUG

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

Placebo to Formoterol

Intervention Type DRUG

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

Indacaterol 600 µg (Not Continued Into Stage 2)

In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.

Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

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

Placebo to Formoterol

Intervention Type DRUG

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

Formoterol 12 µg (Not Continued Into Stage 2)

In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.

Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

Group Type ACTIVE_COMPARATOR

Formoterol (12 µg b.i.d.)

Intervention Type DRUG

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

Placebo to Indacaterol

Intervention Type DRUG

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

Interventions

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Indacaterol

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

Intervention Type 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.

Intervention Type DRUG

Tiotropium (18 µg o.d.)

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

Intervention Type DRUG

Placebo to Indacaterol

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

Intervention Type DRUG

Placebo to Formoterol

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:

* Smoking history of at least 20 pack years
* Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value.
* Post-bronchodilator FEV1/FVC \< 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)

Exclusion Criteria

* Pregnant or lactating females
* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
* Patients requiring long term oxygen therapy (\> 15 h a day)
* Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)
* Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
* Patients with a history of asthma (with further criteria)
* Patients with Type I or uncontrolled Type II diabetes
* Patients with contraindications for tiotropium
* Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
* Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
* Patients with a history of long QT syndrome or whose QTc interval is prolonged
* Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures
* Patients who have had treatment with the investigational drug (with further criteria)
* Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period
* Patients with known history of non compliance to medication
* Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Pinnacle Research Group, LLC

Anniston, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Pulmonary Medicine Associates PC

Homewood, Alabama, United States

Site Status

Jasper Summit Research

Jasper, Alabama, United States

Site Status

Pulmonary Associate of Mobile, PC

Mobile, Alabama, United States

Site Status

Pulmonary Associates, PA

Glendale, Arizona, United States

Site Status

Pulmonary Associates, PA

Phoenix, Arizona, United States

Site Status

Novartis Investigative Center

Scottsdale, Arizona, United States

Site Status

Arizona Pulmonary Specialists, LTD

Scottsdale, Arizona, United States

Site Status

Premiere Pharmaceutical Research, LLC

Tempe, Arizona, United States

Site Status

Canyon Clinical Research, LLC

Tucson, Arizona, United States

Site Status

SAVAHSC / Pulmonary Section

Tucson, Arizona, United States

Site Status

Novartis Investigator Site

Pine Bluff, Arkansas, United States

Site Status

Novartis Investigator Site

Buena Park, California, United States

Site Status

USC Rancho Amigos Medical Center

Downey, California, United States

Site Status

Encompass Clinical Research - North Coast

Encinitas, California, United States

Site Status

California Research

Fullerton, California, United States

Site Status

Allergy and Asthma Specialists Medical Group and research Center

Huntington Beach, California, United States

Site Status

Interlink Research Institute

Los Alamitos, California, United States

Site Status

Allergy Research Foundation, Inc

Los Angeles, California, United States

Site Status

Novartis Investigator Site

Los Angeles, California, United States

Site Status

Southern California Institute for Respiratory Diseases

Los Angeles, California, United States

Site Status

David Geffen UCLA School of Medicine

Los Angeles, California, United States

Site Status

Advance Clinical Research Institute

Orange, California, United States

Site Status

California Allergy & Asthma Medical Group

Palmdale, California, United States

Site Status

Intergrated Research Group

Riverside, California, United States

Site Status

Allergy & Asthma Associates of Santa Clara Res. Center

San Jose, California, United States

Site Status

Greater Los Angeles Healthcare System

Sepulveda, California, United States

Site Status

Encompass Clinical Research

Spring Valley, California, United States

Site Status

Bensch Clinical Research Associates

Stockton, California, United States

Site Status

Peninsula Pulmonary Medical Associates

Torrance, California, United States

Site Status

Progressive Clinical Research

Vista, California, United States

Site Status

Allergy and Asthma Clinical Research Inc

Walnut Creek, California, United States

Site Status

Boulder Medical Center

Boulder, Colorado, United States

Site Status

National Jewish Medical & Research Center

Denver, Colorado, United States

Site Status

Northern Colorado Pulmonary Consultants, PC

Fort Collins, Colorado, United States

Site Status

New West Physicians Clinical research

Golden, Colorado, United States

Site Status

Rocky Mountain Center for Clinical Research

Wheat Ridge, Colorado, United States

Site Status

Western States Clinical Research

Wheat Ridge, Colorado, United States

Site Status

Norwalk Hospital

Norwalk, Connecticut, United States

Site Status

Lung Health & Sleep Enhancement Center

Newark, Delaware, United States

Site Status

Clinical Research of West Florida

Clearwater, Florida, United States

Site Status

University of Florida Shands Hospital

Gainesville, Florida, United States

Site Status

Shands Jacksonville Medical Center

Jacksonville, Florida, United States

Site Status

Innovative Research of West Florida

Largo, Florida, United States

Site Status

University of Miami School of Medicine

Miami, Florida, United States

Site Status

Elite Research Institute

Miami, Florida, United States

Site Status

Novartis Investigator Site

Pembroke Pines, Florida, United States

Site Status

Emerald Coast Clinical Research, LLC

Pensacola, Florida, United States

Site Status

Pensacola Research Consultants

Pensacola, Florida, United States

Site Status

Integrity Research

Pensacola, Florida, United States

Site Status

Brevard Pulmonary Specialists

Rockledge, Florida, United States

Site Status

Asthma & Allergy Research Center

Sarasota, Florida, United States

Site Status

South Miami Clinical Research, LLC

South Miami, Florida, United States

Site Status

Central Medical Group, PA

Tamarac, Florida, United States

Site Status

Clireco, Inc

Tamarac, Florida, United States

Site Status

Novartis Investigator Site

Tampa, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Neutrotrials Research Inc

Atlanta, Georgia, United States

Site Status

Georgia Clinical Research

Austell, Georgia, United States

Site Status

Marietta Pulmonary Medicine

Marietta, Georgia, United States

Site Status

University of Chicago Hospital

Chicago, Illinois, United States

Site Status

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, United States

Site Status

Southern Illinois Clinical Research Center

O'Fallon, Illinois, United States

Site Status

Novartis Investigator Site

River Forest, Illinois, United States

Site Status

Community Hospital Anderson

Anderson, Indiana, United States

Site Status

Dawes Fretzin Clinical Research Group LLC

Indianapolis, Indiana, United States

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South Bend Clinic

South Bend, Indiana, United States

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Iowa Clinical Research Corporation

Iowa City, Iowa, United States

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University of Iowa

Iowa City, Iowa, United States

Site Status

Heart of America Research Institute

Shawnee Mission, Kansas, United States

Site Status

Cotton-O'Neil Clinical Research Center

Topeka, Kansas, United States

Site Status

Novartis Investigator Site

Crescent Springs, Kentucky, United States

Site Status

Kentucky Medical research Center

Lexington, Kentucky, United States

Site Status

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Site Status

Family Asthma and Allergy Research Associates

Louisville, Kentucky, United States

Site Status

Gulf Coast Research, LLC

Lafayette, Louisiana, United States

Site Status

Rx R&D

Metaire, Louisiana, United States

Site Status

LSU Health Sciences Center/LSU School of Medicine

New Orleans, Louisiana, United States

Site Status

New Orleans Center for Clinical Research

New Orleans, Louisiana, United States

Site Status

Louisiana Health Sciences Center

Shreveport, Louisiana, United States

Site Status

Northshore Research Associates

Slidell, Louisiana, United States

Site Status

Allergy, Asthma, Immunology, Pharmaceutical Studies

Bangor, Maine, United States

Site Status

Primecare Physician Associates

Biddeford, Maine, United States

Site Status

John Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

Site Status

Miray Medical Center

Brockton, Massachusetts, United States

Site Status

Fallon Clinic at Worcester Medical Center

Worcester, Massachusetts, United States

Site Status

ClinSite, Inc

Ann Arbor, Michigan, United States

Site Status

Novartis Investigator Site

Clarkston, Michigan, United States

Site Status

Harper University Hospital; Wayne State University

Detroit, Michigan, United States

Site Status

Novartis Investigator Site

Flint, Michigan, United States

Site Status

Pulmonary Respiratory Institute of Southwest Michigan

Livonia, Michigan, United States

Site Status

Novartis Investigator Site

Port Huron, Michigan, United States

Site Status

Synergy Medical Education Alliance

Saginaw, Michigan, United States

Site Status

Novartis Investigator Site

Troy, Michigan, United States

Site Status

Minnesota Lung Center

Edina, Minnesota, United States

Site Status

Clinical Research Institute

Minneapolis, Minnesota, United States

Site Status

Novartis Investigator Site

Minneapolis, Minnesota, United States

Site Status

Minnesota Lung Center

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

St. Luke's Cardio-Pulmonary Research

Chesterfield, Missouri, United States

Site Status

University of Missouri - Columbia

Columbia, Missouri, United States

Site Status

Kansas City University of Medicine and Biosciences

Kansas City, Missouri, United States

Site Status

University of Missouri KC/ Truman Medical

Kansas City, Missouri, United States

Site Status

Midwest Chest Consultants

Saint Charles, Missouri, United States

Site Status

Washington U School of Medicine, Center for Clinical Studies

St Louis, Missouri, United States

Site Status

The Clinical Research Centre

St Louis, Missouri, United States

Site Status

Montana Health Research Institute

Billings, Montana, United States

Site Status

Novartis Investigator Site

Kalispell, Montana, United States

Site Status

Novartis Investigator Site

Missoula, Montana, United States

Site Status

Somnos Laboratories, Inc

Lincoln, Nebraska, United States

Site Status

Omaha VA Medical Center

Omaha, Nebraska, United States

Site Status

Quality Clinical Research

Omaha, Nebraska, United States

Site Status

Midwest Allergy and Asthma Clinic

Omaha, Nebraska, United States

Site Status

Creighton University Centre for Allergy, Asthma & Immunology

Omaha, Nebraska, United States

Site Status

Creigton University

Omaha, Nebraska, United States

Site Status

Heartland Clinical Research, Inc

Omaha, Nebraska, United States

Site Status

Meridian Clinical Research, LLC

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center - Pulmonary Research

Omaha, Nebraska, United States

Site Status

The Asthma & Allergy Center, PC

Papillion, Nebraska, United States

Site Status

Lovelace Scientific Resources, Inc.

Henderson, Nevada, United States

Site Status

Clinical Research Center of NV

Las Vegas, Nevada, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Delaware Valley Clinical Research

Cherry Hill, New Jersey, United States

Site Status

Pulmonary and Critical Care Associates, PA

East Brunswick, New Jersey, United States

Site Status

Novartis Investigator Site

Newark, New Jersey, United States

Site Status

Pulmonary and Allergy Associates, PA

Summit, New Jersey, United States

Site Status

Pulmonary and Critical Care Services

Albany, New York, United States

Site Status

Crescent Medical Associates

Astoria, New York, United States

Site Status

Asthma and Allergy Associates

Cortland, New York, United States

Site Status

Asthma and Allergy Associates

Elmira, New York, United States

Site Status

Nassau Chest Physicians, PC

Massapequa, New York, United States

Site Status

North Shore University Hospital

New Hyde Park, New York, United States

Site Status

New York Pulmonary Associates, PC

New York, New York, United States

Site Status

Weill Medical College of Cornell University

New York, New York, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

AAIR research Centre

Rochester, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Sensenbrenner Primary Care

Charlotte, North Carolina, United States

Site Status

North Carolina Clinical Research

Raleigh, North Carolina, United States

Site Status

Novartis Investigator Site

Shelby, North Carolina, United States

Site Status

Cloverdale Research Facility

Winston-Salem, North Carolina, United States

Site Status

Merit Care Medical Group

Fargo, North Dakota, United States

Site Status

Cincinnati VA Hospital

Cincinnati, Ohio, United States

Site Status

New Horizons Clinical Research

Cincinnati, Ohio, United States

Site Status

Bernstein Clinical Research Centre

Cincinnati, Ohio, United States

Site Status

Community Research Inc

Cincinnati, Ohio, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Metro Health Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Ohio State University - Davis Heart and Lung Research Institute

Columbus, Ohio, United States

Site Status

Novartis Investigator Site

Columbus, Ohio, United States

Site Status

Remington-Davis Clinical Research

Columbus, Ohio, United States

Site Status

Novartis Investigator Site

Columbus, Ohio, United States

Site Status

Novartis Investigator Site

Marion, Ohio, United States

Site Status

John Winder Associates

Sylvania, Ohio, United States

Site Status

Advanced Health Care Specialists

Thornville, Ohio, United States

Site Status

The University of Toledo

Toledo, Ohio, United States

Site Status

Pharmacotherapy Research Associates, Inc

Zanesville, Ohio, United States

Site Status

Oklahoma Allergy and Asthma Clinic

Oklahoma City, Oklahoma, United States

Site Status

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Site Status

Lynne Health Science Institute

Oklahoma City, Oklahoma, United States

Site Status

Healthcare Research Consultants, Inc

Tulsa, Oklahoma, United States

Site Status

River Road Medical Group

Eugene, Oregon, United States

Site Status

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, United States

Site Status

Oregon Clinical Research Associates

Medford, Oregon, United States

Site Status

Allergy Associates Research Center

Portland, Oregon, United States

Site Status

Novartis Investigator Site

Portland, Oregon, United States

Site Status

Tri-State Medical Group

Beaver, Pennsylvania, United States

Site Status

Novartis Investigator Site

Easton, Pennsylvania, United States

Site Status

Chest Diseases of Northwestern PA

Erie, Pennsylvania, United States

Site Status

Asthma Allergy &Pulmonary Associates, PC

Philadelphia, Pennsylvania, United States

Site Status

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigator Site

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigator Site

Philadelphia, Pennsylvania, United States

Site Status

Pittsburgh Pulmonary Associates

Pittsburgh, Pennsylvania, United States

Site Status

South Hills Pulmonary Associates

Pittsburgh, Pennsylvania, United States

Site Status

New England Center for Clinical Research

Cranston, Rhode Island, United States

Site Status

Partners in Clinical Research

Cumberland, Rhode Island, United States

Site Status

Low County Lung and Critical Care, PA

Charleston, South Carolina, United States

Site Status

Hugh D. Durrence, MD, Family Medicine

Charleston, South Carolina, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Med Plus South - Strand Family Practice

Garden City, South Carolina, United States

Site Status

Novartis Investigator Site

Greenville, South Carolina, United States

Site Status

Spartanburg Pharmaceutical Research

Spartanburg, South Carolina, United States

Site Status

Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab

Varnville, South Carolina, United States

Site Status

MultiSpeciality Clinical Research

Johnson City, Tennessee, United States

Site Status

Holston Medical Group

Kingsport, Tennessee, United States

Site Status

Volunteer Research Center

Knoxville, Tennessee, United States

Site Status

Dickson Family Medicine Group, PC

Nashville, Tennessee, United States

Site Status

Novartis Investigator Site

Nashville, Tennessee, United States

Site Status

Heartland Medical, P.C

New Tazewell, Tennessee, United States

Site Status

PharmaTex Research LLC

Amarillo, Texas, United States

Site Status

Trinity Clinic - Corsicana

Corsicana, Texas, United States

Site Status

Pharmaceutical Research & Consulting, Inc

Dallas, Texas, United States

Site Status

Asthma & Allergy Research Associates

Dallas, Texas, United States

Site Status

Western Sky Medical Research

El Paso, Texas, United States

Site Status

Texas Pulmonary & Critical Care

Fort Worth, Texas, United States

Site Status

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Site Status

*Private Practice*

Houston, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Houstons Veteran's Medical Center

Houston, Texas, United States

Site Status

West Houston Allergy and Asthma, PA

Katy, Texas, United States

Site Status

Central Texas Health Research

New Braunfels, Texas, United States

Site Status

Quality Assurance Research Centre

San Antonio, Texas, United States

Site Status

Audie L. Murphy VA Hospital

San Antonio, Texas, United States

Site Status

Allergy and Asthma Research Center, PA

San Antonio, Texas, United States

Site Status

Diagnostics Research Group

San Antonio, Texas, United States

Site Status

Wellmed Clinical Research

San Antonio, Texas, United States

Site Status

Vermont Lung Center

Colchester, Vermont, United States

Site Status

Johnston Memorial Hospital Pulmonary Research

Abingdon, Virginia, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Lynchburg Pulmonary Associates

Lynchburg, Virginia, United States

Site Status

Novartis Investigator Site

Richmond, Virginia, United States

Site Status

Madrona Medical Group - Clinical Research Dept.

Bellingham, Washington, United States

Site Status

Pulmonary and Research Associates

Spokane, Washington, United States

Site Status

William L. Gray Research

Spokane, Washington, United States

Site Status

Pulmonary Consultants, PLLC

Tacoma, Washington, United States

Site Status

Madigan Army medical Center / Dept. of Army

Tacoma, Washington, United States

Site Status

Charleston Area Medical Center

Charleston, West Virginia, United States

Site Status

Novartis Investigator Site

Milwaukee, Wisconsin, United States

Site Status

Novartis Investigator Site

Buenos Aires, , Argentina

Site Status

Novartis

Buenos Aires, , Argentina

Site Status

Novartis Investigator Site

Capital Federal, , Argentina

Site Status

Novartis Investigator Site

Santa Fe, , Argentina

Site Status

Novartis Investigator Site

Ajax, , Canada

Site Status

Novartis Investigator Site

Calgary, , Canada

Site Status

Novartis Investigator Site

Chatham, , Canada

Site Status

Novartis Investigator Site

Gatineau, , Canada

Site Status

Novartis Investigator Site

Moncton, , Canada

Site Status

Novartis Investigator Site

Montreal, , Canada

Site Status

Novartis Investigator Site

Niagara Falls, , Canada

Site Status

Novartis Investigator Site

Ottawa, , Canada

Site Status

Novartis

Québec, , Canada

Site Status

Novartis Investigator Site

Saint Romuald, , Canada

Site Status

Novartis Investigator Site

Saskatoon, , Canada

Site Status

Novartis Investigator Site

Sherbrooke, , Canada

Site Status

Novartis Investigator Site

St. John's, , Canada

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Ste-Foy, , Canada

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Toronto, , Canada

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Trois-Rivières, , Canada

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Vancouver, , Canada

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Waterloo, , Canada

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Windsor, , Canada

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Winnipeg, , Canada

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Augsburg, , Germany

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Bad Segeberg, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bonn, , Germany

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Brühl, , Germany

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Dachau, , Germany

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Fürth, , Germany

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Hamburg, , Germany

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Hoyerswerda, , Germany

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Kaufbeuren, , Germany

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Landsberg, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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München, , Germany

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Oranienburg, , Germany

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Oschersleben, , Germany

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Potsdam, , Germany

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Ratingen, , Germany

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Steinfurt, , Germany

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Wuppertal, , Germany

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Bangalore, , India

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Banglore, , India

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Caranazalem, , India

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Chennai, , India

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Coimbatore, , India

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Hyderabaad, , India

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Indore, , India

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Jaipur, , India

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Kolkata, , India

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Ludhiana, , India

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Mumbai, , India

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Trivandrum, , India

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Bologna, , Italy

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Busto Arsizio, , Italy

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Catania, , Italy

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Catanzaro, , Italy

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Chioggia, , Italy

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Crema, , Italy

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Ferrara, , Italy

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Florence, , Italy

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Genova, , Italy

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Messina, , Italy

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Milan, , Italy

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Milan, , Italy

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Pisa, , Italy

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Roma, , Italy

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Rozzano, , Italy

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Siena, , Italy

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Ponce, , Puerto Rico

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Bucheon-si, , South Korea

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Busan, , South Korea

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Chuncheon, , South Korea

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Daegu, , South Korea

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Kwangju, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Wŏnju, , South Korea

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A Coruña, , Spain

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Alicante, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Burgos, , Spain

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Cadiz, , Spain

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Calde Lugo, , Spain

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Galdakano, , Spain

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Girona, , Spain

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Gran Canaria, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Ourense, , Spain

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Oviedo, , Spain

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Palma de Mallorca, , Spain

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Ponferrada, , Spain

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Pontevedra, , Spain

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Port de Sagunt, , Spain

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Seville, , Spain

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Valencia, , Spain

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Vic, , Spain

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Vila-real, , Spain

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Zaragoza, , Spain

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Gothenburg, , Sweden

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Jönköping, , Sweden

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Lidingö, , Sweden

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Luleå, , Sweden

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Lund, , Sweden

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Chiayi City, , Taiwan

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Linkou District, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Konya, , Turkey (Türkiye)

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Manisa, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Yenişehir, , Turkey (Türkiye)

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Countries

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United States Argentina Canada Germany India Italy Puerto Rico South Korea Spain Sweden Taiwan Turkey (Türkiye)

References

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Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.

Reference Type DERIVED
PMID: 22206353 (View on PubMed)

Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.

Reference Type DERIVED
PMID: 22158330 (View on PubMed)

Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.

Reference Type DERIVED
PMID: 21397482 (View on PubMed)

Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.

Reference Type DERIVED
PMID: 21227674 (View on PubMed)

Donohue JF, Fogarty C, Lotvall J, Mahler DA, Worth H, Yorgancioglu A, Iqbal A, Swales J, Owen R, Higgins M, Kramer B; INHANCE Study Investigators. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010 Jul 15;182(2):155-62. doi: 10.1164/rccm.200910-1500OC. Epub 2010 May 12.

Reference Type DERIVED
PMID: 20463178 (View on PubMed)

Other Identifiers

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CQAB149B2335S

Identifier Type: -

Identifier Source: org_study_id

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