26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg b.i.d.) and Open Label Tiotropium (18 µg o.d.) as Active Controls
1 other identifier
interventional
2,059
12 countries
344
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2007
Shorter than P25 for phase_2
344 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 19, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
August 18, 2011
CompletedAugust 18, 2011
July 1, 2011
1.3 years
April 19, 2007
July 22, 2011
July 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.
after 12 weeks of treatment
Secondary Outcomes (1)
The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period
up to 26 weeks
Other Outcomes (2)
Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment
Day 15, After 2 Weeks of treatment in Stage 1
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment
Day 14, After 2 Weeks of treatment in Stage 1
Study Arms (7)
Indacaterol 150 µg (Continued Into Stage 2)
EXPERIMENTALIn 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.
Indacaterol 300 µg (Continued Into Stage 2)
EXPERIMENTALIn 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.
Tiotropium 18 µg (Continued Into Stage 2)
ACTIVE COMPARATORTiotropium 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.
Placebo (Continued Into Stage 2)
PLACEBO COMPARATORIn 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.
Indacaterol 75 µg (Not Continued into Stage 2)
EXPERIMENTALIn 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.
Indacaterol 600 µg (Not Continued Into Stage 2)
EXPERIMENTALIn 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.
Formoterol 12 µg (Not Continued Into Stage 2)
ACTIVE COMPARATORIn 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.
Interventions
In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.
Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.
In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (344)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Pulmonary Medicine Associates PC
Homewood, Alabama, 35209, United States
Jasper Summit Research
Jasper, Alabama, 35501, United States
Pulmonary Associate of Mobile, PC
Mobile, Alabama, 36608, United States
Pulmonary Associates, PA
Glendale, Arizona, 85306, United States
Pulmonary Associates, PA
Phoenix, Arizona, 85006, United States
Novartis Investigative Center
Scottsdale, Arizona, 85255, United States
Arizona Pulmonary Specialists, LTD
Scottsdale, Arizona, 85258, United States
Premiere Pharmaceutical Research, LLC
Tempe, Arizona, 85282, United States
Canyon Clinical Research, LLC
Tucson, Arizona, 85712, United States
SAVAHSC / Pulmonary Section
Tucson, Arizona, 85723, United States
Novartis Investigator Site
Pine Bluff, Arkansas, 71603, United States
Novartis Investigator Site
Buena Park, California, 90620, United States
USC Rancho Amigos Medical Center
Downey, California, 90242, United States
Encompass Clinical Research - North Coast
Encinitas, California, 92024, United States
California Research
Fullerton, California, 92835, United States
Allergy and Asthma Specialists Medical Group and research Center
Huntington Beach, California, 92647, United States
Interlink Research Institute
Los Alamitos, California, 90720, United States
Allergy Research Foundation, Inc
Los Angeles, California, 90025, United States
Novartis Investigator Site
Los Angeles, California, 90033, United States
Southern California Institute for Respiratory Diseases
Los Angeles, California, 90048, United States
David Geffen UCLA School of Medicine
Los Angeles, California, 90095, United States
Advance Clinical Research Institute
Orange, California, 92869, United States
California Allergy & Asthma Medical Group
Palmdale, California, 93551, United States
Intergrated Research Group
Riverside, California, 92506, United States
Allergy & Asthma Associates of Santa Clara Res. Center
San Jose, California, 95117, United States
Greater Los Angeles Healthcare System
Sepulveda, California, 91343, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Bensch Clinical Research Associates
Stockton, California, 95207, United States
Peninsula Pulmonary Medical Associates
Torrance, California, 90505, United States
Progressive Clinical Research
Vista, California, 92083, United States
Allergy and Asthma Clinical Research Inc
Walnut Creek, California, 94598, United States
Boulder Medical Center
Boulder, Colorado, 80304, United States
National Jewish Medical & Research Center
Denver, Colorado, 80206, United States
Northern Colorado Pulmonary Consultants, PC
Fort Collins, Colorado, 80528, United States
New West Physicians Clinical research
Golden, Colorado, 80401, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033, United States
Western States Clinical Research
Wheat Ridge, Colorado, 80033, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Lung Health & Sleep Enhancement Center
Newark, Delaware, 19713, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
University of Florida Shands Hospital
Gainesville, Florida, 32610 - 0277, United States
Shands Jacksonville Medical Center
Jacksonville, Florida, 32209, United States
Innovative Research of West Florida
Largo, Florida, 33770, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Elite Research Institute
Miami, Florida, 33169, United States
Novartis Investigator Site
Pembroke Pines, Florida, 33029, United States
Emerald Coast Clinical Research, LLC
Pensacola, Florida, 32504, United States
Pensacola Research Consultants
Pensacola, Florida, 32504, United States
Integrity Research
Pensacola, Florida, 32514, United States
Brevard Pulmonary Specialists
Rockledge, Florida, 32955, United States
Asthma & Allergy Research Center
Sarasota, Florida, 34233, United States
South Miami Clinical Research, LLC
South Miami, Florida, 33143, United States
Central Medical Group, PA
Tamarac, Florida, 33321, United States
Clireco, Inc
Tamarac, Florida, 33321, United States
Novartis Investigator Site
Tampa, Florida, 33603, United States
University of South Florida
Tampa, Florida, 33613, United States
Neutrotrials Research Inc
Atlanta, Georgia, 30342, United States
Georgia Clinical Research
Austell, Georgia, 30106, United States
Marietta Pulmonary Medicine
Marietta, Georgia, 30060, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, 61761, United States
Southern Illinois Clinical Research Center
O'Fallon, Illinois, 62269, United States
Novartis Investigator Site
River Forest, Illinois, 60305, United States
Community Hospital Anderson
Anderson, Indiana, 46011, United States
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana, 46256, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Iowa Clinical Research Corporation
Iowa City, Iowa, 52240, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Heart of America Research Institute
Shawnee Mission, Kansas, 66216, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Novartis Investigator Site
Crescent Springs, Kentucky, 41017, United States
Kentucky Medical research Center
Lexington, Kentucky, 40504, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Family Asthma and Allergy Research Associates
Louisville, Kentucky, 40215, United States
Gulf Coast Research, LLC
Lafayette, Louisiana, 70503, United States
Rx R&D
Metaire, Louisiana, 70002, United States
LSU Health Sciences Center/LSU School of Medicine
New Orleans, Louisiana, 70112, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Louisiana Health Sciences Center
Shreveport, Louisiana, 71103, United States
Northshore Research Associates
Slidell, Louisiana, 70461, United States
Allergy, Asthma, Immunology, Pharmaceutical Studies
Bangor, Maine, 04401, United States
Primecare Physician Associates
Biddeford, Maine, 04005, United States
John Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224, United States
Miray Medical Center
Brockton, Massachusetts, 02302, United States
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, 01604, United States
ClinSite, Inc
Ann Arbor, Michigan, 48106-0525, United States
Novartis Investigator Site
Clarkston, Michigan, 48346, United States
Harper University Hospital; Wayne State University
Detroit, Michigan, 48201, United States
Novartis Investigator Site
Flint, Michigan, 48532, United States
Pulmonary Respiratory Institute of Southwest Michigan
Livonia, Michigan, 48152, United States
Novartis Investigator Site
Port Huron, Michigan, 48060, United States
Synergy Medical Education Alliance
Saginaw, Michigan, 48602 - 5303, United States
Novartis Investigator Site
Troy, Michigan, 48085, United States
Minnesota Lung Center
Edina, Minnesota, 55435, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Novartis Investigator Site
Minneapolis, Minnesota, 55402, United States
Minnesota Lung Center
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
St. Luke's Cardio-Pulmonary Research
Chesterfield, Missouri, 63017, United States
University of Missouri - Columbia
Columbia, Missouri, 65212, United States
Kansas City University of Medicine and Biosciences
Kansas City, Missouri, 64106 - 1453, United States
University of Missouri KC/ Truman Medical
Kansas City, Missouri, 64108-2677, United States
Midwest Chest Consultants
Saint Charles, Missouri, 63301, United States
Washington U School of Medicine, Center for Clinical Studies
St Louis, Missouri, 63110, United States
The Clinical Research Centre
St Louis, Missouri, 63141, United States
Montana Health Research Institute
Billings, Montana, 59102, United States
Novartis Investigator Site
Kalispell, Montana, 59901, United States
Novartis Investigator Site
Missoula, Montana, 59808, United States
Somnos Laboratories, Inc
Lincoln, Nebraska, 68510, United States
Omaha VA Medical Center
Omaha, Nebraska, 68105, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Midwest Allergy and Asthma Clinic
Omaha, Nebraska, 68130, United States
Creighton University Centre for Allergy, Asthma & Immunology
Omaha, Nebraska, 68131, United States
Creigton University
Omaha, Nebraska, 68131, United States
Heartland Clinical Research, Inc
Omaha, Nebraska, 68134, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
University of Nebraska Medical Center - Pulmonary Research
Omaha, Nebraska, 68198 - 5885, United States
The Asthma & Allergy Center, PC
Papillion, Nebraska, 68046, United States
Lovelace Scientific Resources, Inc.
Henderson, Nevada, 89014, United States
Clinical Research Center of NV
Las Vegas, Nevada, 89131, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Delaware Valley Clinical Research
Cherry Hill, New Jersey, 08003, United States
Pulmonary and Critical Care Associates, PA
East Brunswick, New Jersey, 08816, United States
Novartis Investigator Site
Newark, New Jersey, 7101, United States
Pulmonary and Allergy Associates, PA
Summit, New Jersey, 07901, United States
Pulmonary and Critical Care Services
Albany, New York, 12205, United States
Crescent Medical Associates
Astoria, New York, 11102, United States
Asthma and Allergy Associates
Cortland, New York, 13045, United States
Asthma and Allergy Associates
Elmira, New York, 14905, United States
Nassau Chest Physicians, PC
Massapequa, New York, 11758, United States
North Shore University Hospital
New Hyde Park, New York, 11040, United States
New York Pulmonary Associates, PC
New York, New York, 10016, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
AAIR research Centre
Rochester, New York, 14618, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Sensenbrenner Primary Care
Charlotte, North Carolina, 28277, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Novartis Investigator Site
Shelby, North Carolina, 28150, United States
Cloverdale Research Facility
Winston-Salem, North Carolina, 27103, United States
Merit Care Medical Group
Fargo, North Dakota, 58122, United States
Cincinnati VA Hospital
Cincinnati, Ohio, 45220, United States
New Horizons Clinical Research
Cincinnati, Ohio, 452242, United States
Bernstein Clinical Research Centre
Cincinnati, Ohio, 45231, United States
Community Research Inc
Cincinnati, Ohio, 45245, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Metro Health Medical Center
Cleveland, Ohio, 44109-1998, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University - Davis Heart and Lung Research Institute
Columbus, Ohio, 43210, United States
Novartis Investigator Site
Columbus, Ohio, 43213, United States
Remington-Davis Clinical Research
Columbus, Ohio, 43215, United States
Novartis Investigator Site
Columbus, Ohio, 43235, United States
Novartis Investigator Site
Marion, Ohio, 43302, United States
John Winder Associates
Sylvania, Ohio, 43650, United States
Advanced Health Care Specialists
Thornville, Ohio, 43076, United States
The University of Toledo
Toledo, Ohio, 43614, United States
Pharmacotherapy Research Associates, Inc
Zanesville, Ohio, 43701, United States
Oklahoma Allergy and Asthma Clinic
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Lynne Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Healthcare Research Consultants, Inc
Tulsa, Oklahoma, 74135, United States
River Road Medical Group
Eugene, Oregon, 97404, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504, United States
Oregon Clinical Research Associates
Medford, Oregon, 97504, United States
Allergy Associates Research Center
Portland, Oregon, 97213, United States
Novartis Investigator Site
Portland, Oregon, 97227-1110, United States
Tri-State Medical Group
Beaver, Pennsylvania, 15009 - 1957, United States
Novartis Investigator Site
Easton, Pennsylvania, 18045, United States
Chest Diseases of Northwestern PA
Erie, Pennsylvania, 16506, United States
Asthma Allergy &Pulmonary Associates, PC
Philadelphia, Pennsylvania, 19107, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19107, United States
Novartis Investigator Site
Philadelphia, Pennsylvania, 19140, United States
Novartis Investigator Site
Philadelphia, Pennsylvania, 19141, United States
Pittsburgh Pulmonary Associates
Pittsburgh, Pennsylvania, 15025, United States
South Hills Pulmonary Associates
Pittsburgh, Pennsylvania, 15243, United States
New England Center for Clinical Research
Cranston, Rhode Island, 02920, United States
Partners in Clinical Research
Cumberland, Rhode Island, 02864, United States
Low County Lung and Critical Care, PA
Charleston, South Carolina, 29406-7108, United States
Hugh D. Durrence, MD, Family Medicine
Charleston, South Carolina, 29412, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Med Plus South - Strand Family Practice
Garden City, South Carolina, 29576, United States
Novartis Investigator Site
Greenville, South Carolina, 29615, United States
Spartanburg Pharmaceutical Research
Spartanburg, South Carolina, 29303, United States
Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab
Varnville, South Carolina, 29944, United States
MultiSpeciality Clinical Research
Johnson City, Tennessee, 37601, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Volunteer Research Center
Knoxville, Tennessee, 37920, United States
Dickson Family Medicine Group, PC
Nashville, Tennessee, 37203, United States
Novartis Investigator Site
Nashville, Tennessee, 37208-3599, United States
Heartland Medical, P.C
New Tazewell, Tennessee, 37825-1409, United States
PharmaTex Research LLC
Amarillo, Texas, 79106, United States
Trinity Clinic - Corsicana
Corsicana, Texas, 75110, United States
Pharmaceutical Research & Consulting, Inc
Dallas, Texas, 75231-4307, United States
Asthma & Allergy Research Associates
Dallas, Texas, 75231, United States
Western Sky Medical Research
El Paso, Texas, 79902, United States
Texas Pulmonary & Critical Care
Fort Worth, Texas, 76104, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555 - 0561, United States
*Private Practice*
Houston, Texas, 77024, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houstons Veteran's Medical Center
Houston, Texas, 77030, United States
West Houston Allergy and Asthma, PA
Katy, Texas, 77450, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Quality Assurance Research Centre
San Antonio, Texas, 78205, United States
Audie L. Murphy VA Hospital
San Antonio, Texas, 78229 - 4404, United States
Allergy and Asthma Research Center, PA
San Antonio, Texas, 78229, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Wellmed Clinical Research
San Antonio, Texas, 78229, United States
Vermont Lung Center
Colchester, Vermont, 05446, United States
Johnston Memorial Hospital Pulmonary Research
Abingdon, Virginia, 24210, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Lynchburg Pulmonary Associates
Lynchburg, Virginia, 24501, United States
Novartis Investigator Site
Richmond, Virginia, 23249, United States
Madrona Medical Group - Clinical Research Dept.
Bellingham, Washington, 98226, United States
Pulmonary and Research Associates
Spokane, Washington, 99204, United States
William L. Gray Research
Spokane, Washington, 99216, United States
Pulmonary Consultants, PLLC
Tacoma, Washington, 98405, United States
Madigan Army medical Center / Dept. of Army
Tacoma, Washington, 98431, United States
Charleston Area Medical Center
Charleston, West Virginia, 26304, United States
Novartis Investigator Site
Milwaukee, Wisconsin, 53209, United States
Novartis Investigator Site
Buenos Aires, Argentina
Novartis
Buenos Aires, Argentina
Novartis Investigator Site
Capital Federal, Argentina
Novartis Investigator Site
Santa Fe, Argentina
Novartis Investigator Site
Ajax, Canada
Novartis Investigator Site
Calgary, Canada
Novartis Investigator Site
Chatham, Canada
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Gatineau, Canada
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Moncton, Canada
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Montreal, Canada
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Niagara Falls, Canada
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Ottawa, Canada
Novartis
Québec, Canada
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Saint Romuald, Canada
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Saskatoon, Canada
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Sherbrooke, Canada
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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
Novartis
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
Novartis
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, 716, Puerto Rico
Novartis Investigator Site
Bucheon-si, South Korea
Novartis Investigator Site
Busan, South Korea
Novartis Investigator Site
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)
Related Publications (5)
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.
PMID: 22206353DERIVEDYelensky 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.
PMID: 22158330DERIVEDJones 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.
PMID: 21397482DERIVEDWorth 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.
PMID: 21227674DERIVEDDonohue 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.
PMID: 20463178DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 19, 2007
First Posted
April 20, 2007
Study Start
April 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
August 18, 2011
Results First Posted
August 18, 2011
Record last verified: 2011-07