Trial record 2 of 2 for:    b2335

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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00463567
First received: April 19, 2007
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
COPD
Lung Diseases, Obstructive
Drug: Indacaterol
Drug: Formoterol (12 µg b.i.d.)
Drug: Tiotropium (18 µg o.d.)
Drug: Placebo to Indacaterol
Drug: Placebo to Formoterol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
    A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participant's diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of "days of poor control" as well as FEV1 reversibility components as covariates.


Enrollment: 2059
Study Start Date: April 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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

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

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

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.
Experimental: 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.

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

Drug: Indacaterol
In the morning, 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.
Active Comparator: 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.

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463567

  Hide Study Locations
Locations
United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Pulmonary Medicine Associates PC
Homewood, Alabama, United States, 35209
Jasper Summit Research
Jasper, Alabama, United States, 35501
Pulmonary Associate of Mobile, PC
Mobile, Alabama, United States, 36608
United States, Arizona
Pulmonary Associates, PA
Glendale, Arizona, United States, 85306
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
Arizona Pulmonary Specialists, LTD
Scottsdale, Arizona, United States, 85258
Novartis Investigative Center
Scottsdale, Arizona, United States, 85255
Premiere Pharmaceutical Research, LLC
Tempe, Arizona, United States, 85282
SAVAHSC / Pulmonary Section
Tucson, Arizona, United States, 85723
Canyon Clinical Research, LLC
Tucson, Arizona, United States, 85712
United States, Arkansas
Novartis Investigator Site
Pine Bluff, Arkansas, United States, 71603
United States, California
Novartis Investigator Site
Buena Park, California, United States, 90620
USC Rancho Amigos Medical Center
Downey, California, United States, 90242
Encompass Clinical Research - North Coast
Encinitas, California, United States, 92024
California Research
Fullerton, California, United States, 92835
Allergy and Asthma Specialists Medical Group and research Center
Huntington Beach, California, United States, 92647
Interlink Research Institute
Los Alamitos, California, United States, 90720
David Geffen UCLA School of Medicine
Los Angeles, California, United States, 90095
Allergy Research Foundation, Inc
Los Angeles, California, United States, 90025
Novartis Investigator Site
Los Angeles, California, United States, 90033
Southern California Institute for Respiratory Diseases
Los Angeles, California, United States, 90048
Advance Clinical Research Institute
Orange, California, United States, 92869
California Allergy & Asthma Medical Group
Palmdale, California, United States, 93551
Intergrated Research Group
Riverside, California, United States, 92506
Allergy & Asthma Associates of Santa Clara Res. Center
San Jose, California, United States, 95117
Greater Los Angeles Healthcare System
Sepulveda, California, United States, 91343
Encompass Clinical Research
Spring Valley, California, United States, 91978
Bensch Clinical Research Associates
Stockton, California, United States, 95207
Peninsula Pulmonary Medical Associates
Torrance, California, United States, 90505
Progressive Clinical Research
Vista, California, United States, 92083
Allergy and Asthma Clinical Research Inc
Walnut Creek, California, United States, 94598
United States, Colorado
Boulder Medical Center
Boulder, Colorado, United States, 80304
National Jewish Medical & Research Center
Denver, Colorado, United States, 80206
Northern Colorado Pulmonary Consultants, PC
Fort Collins, Colorado, United States, 80528
New West Physicians Clinical research
Golden, Colorado, United States, 80401
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States, 80033
Western States Clinical Research
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Delaware
Lung Health & Sleep Enhancement Center
Newark, Delaware, United States, 19713
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
University of Florida Shands Hospital
Gainesville, Florida, United States, 32610 - 0277
Shands Jacksonville Medical Center
Jacksonville, Florida, United States, 32209
Innovative Research of West Florida
Largo, Florida, United States, 33770
University of Miami School of Medicine
Miami, Florida, United States, 33136
Elite Research Institute
Miami, Florida, United States, 33169
Novartis Investigator Site
Pembroke Pines, Florida, United States, 33029
Integrity Research
Pensacola, Florida, United States, 32514
Pensacola Research Consultants
Pensacola, Florida, United States, 32504
Emerald Coast Clinical Research, LLC
Pensacola, Florida, United States, 32504
Brevard Pulmonary Specialists
Rockledge, Florida, United States, 32955
Asthma & Allergy Research Center
Sarasota, Florida, United States, 34233
South Miami Clinical Research, LLC
South Miami, Florida, United States, 33143
Central Medical Group, PA
Tamarac, Florida, United States, 33321
Clireco, Inc
Tamarac, Florida, United States, 33321
Novartis Investigator Site
Tampa, Florida, United States, 33603
University of South Florida
Tampa, Florida, United States, 33613
United States, Georgia
Neutrotrials Research Inc
Atlanta, Georgia, United States, 30342
Georgia Clinical Research
Austell, Georgia, United States, 30106
Marietta Pulmonary Medicine
Marietta, Georgia, United States, 30060
United States, Illinois
University of Chicago Hospital
Chicago, Illinois, United States, 60637
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States, 61761
Southern Illinois Clinical Research Center
O'Fallon, Illinois, United States, 62269
Novartis Investigator Site
River Forest, Illinois, United States, 60305
United States, Indiana
Community Hospital Anderson
Anderson, Indiana, United States, 46011
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana, United States, 46256
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Iowa
Iowa Clinical Research Corporation
Iowa City, Iowa, United States, 52240
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Heart of America Research Institute
Shawnee Mission, Kansas, United States, 66216
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
United States, Kentucky
Novartis Investigator Site
Crescent Springs, Kentucky, United States, 41017
Kentucky Medical research Center
Lexington, Kentucky, United States, 40504
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536
Family Asthma and Allergy Research Associates
Louisville, Kentucky, United States, 40215
United States, Louisiana
Gulf Coast Research, LLC
Lafayette, Louisiana, United States, 70503
Rx R&D
Metaire, Louisiana, United States, 70002
LSU Health Sciences Center/LSU School of Medicine
New Orleans, Louisiana, United States, 70112
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States, 70119
Louisiana Health Sciences Center
Shreveport, Louisiana, United States, 71103
Northshore Research Associates
Slidell, Louisiana, United States, 70461
United States, Maine
Allergy, Asthma, Immunology, Pharmaceutical Studies
Bangor, Maine, United States, 04401
Primecare Physician Associates
Biddeford, Maine, United States, 04005
United States, Maryland
John Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Miray Medical Center
Brockton, Massachusetts, United States, 02302
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, United States, 01604
United States, Michigan
ClinSite, Inc
Ann Arbor, Michigan, United States, 48106-0525
Novartis Investigator Site
Clarkston, Michigan, United States, 48346
Harper University Hospital; Wayne State University
Detroit, Michigan, United States, 48201
Novartis Investigator Site
Flint, Michigan, United States, 48532
Pulmonary Respiratory Institute of Southwest Michigan
Livonia, Michigan, United States, 48152
Novartis Investigator Site
Port Huron, Michigan, United States, 48060
Synergy Medical Education Alliance
Saginaw, Michigan, United States, 48602 - 5303
Novartis Investigator Site
Troy, Michigan, United States, 48085
United States, Minnesota
Minnesota Lung Center
Edina, Minnesota, United States, 55435
Novartis Investigator Site
Minneapolis, Minnesota, United States, 55402
Minnesota Lung Center
Minneapolis, Minnesota, United States, 55407
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Luke's Cardio-Pulmonary Research
Chesterfield, Missouri, United States, 63017
University of Missouri - Columbia
Columbia, Missouri, United States, 65212
University of Missouri KC/ Truman Medical
Kansas City, Missouri, United States, 64108-2677
Kansas City University of Medicine and Biosciences
Kansas City, Missouri, United States, 64106 - 1453
The Clinical Research Centre
St, Louis, Missouri, United States, 63141
Midwest Chest Consultants
St. Charles, Missouri, United States, 63301
Washington U School of Medicine, Center for Clinical Studies
St. Louis, Missouri, United States, 63110
United States, Montana
Montana Health Research Institute
Billings, Montana, United States, 59102
Novartis Investigator Site
Kalispell, Montana, United States, 59901
Novartis Investigator Site
Missoula, Montana, United States, 59808
United States, Nebraska
Somnos Laboratories, Inc
Lincoln, Nebraska, United States, 68510
Creighton University Centre for Allergy, Asthma & Immunology
Omaha, Nebraska, United States, 68131
Midwest Allergy and Asthma Clinic
Omaha, Nebraska, United States, 68130
Heartland Clinical Research, Inc
Omaha, Nebraska, United States, 68134
Omaha VA Medical Center
Omaha, Nebraska, United States, 68105
Quality Clinical Research
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center - Pulmonary Research
Omaha, Nebraska, United States, 68198 - 5885
Creigton University
Omaha, Nebraska, United States, 68131
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
The Asthma & Allergy Center, PC
Papillion, Nebraska, United States, 68046
United States, Nevada
Lovelace Scientific Resources, Inc.
Henderson, Nevada, United States, 89014
Clinical Research Center of NV
Las Vegas, Nevada, United States, 89131
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Delaware Valley Clinical Research
Cherry Hill, New Jersey, United States, 08003
Pulmonary and Critical Care Associates, PA
East Brunswick, New Jersey, United States, 08816
Novartis Investigator Site
Newark, New Jersey, United States, 7101
Pulmonary and Allergy Associates, PA
Summit, New Jersey, United States, 07901
United States, New York
Pulmonary and Critical Care Services
Albany, New York, United States, 12205
Crescent Medical Associates
Astoria, New York, United States, 11102
Asthma and Allergy Associates
Cortland, New York, United States, 13045
Asthma and Allergy Associates
Elmira, New York, United States, 14905
Nassau Chest Physicians, PC
Massapequa, New York, United States, 11758
North Shore University Hospital
New Hyde Park, New York, United States, 11040
New York Pulmonary Associates, PC
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029
Weill Medical College of Cornell University
New York, New York, United States, 10021
AAIR research Centre
Rochester, New York, United States, 14618
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sensenbrenner Primary Care
Charlotte, North Carolina, United States, 28277
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
Novartis Investigator Site
Shelby, North Carolina, United States, 28150
Cloverdale Research Facility
Winston Salem, North Carolina, United States, 27103
United States, North Dakota
Merit Care Medical Group
Fargo, North Dakota, United States, 58122
United States, Ohio
Community Research Inc
Cincinnati, Ohio, United States, 45245
Bernstein Clinical Research Centre
Cincinnati, Ohio, United States, 45231
Cincinnati VA Hospital
Cincinnati, Ohio, United States, 45220
New Horizons Clinical Research
Cincinnati, Ohio, United States, 452242
Metro Health Medical Center
Cleveland, Ohio, United States, 44109-1998
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Remington-Davis Clinical Research
Columbus, Ohio, United States, 43215
Ohio State University - Davis Heart and Lung Research Institute
Columbus, Ohio, United States, 43210
Novartis Investigator Site
Columbus, Ohio, United States, 43235
Novartis Investigator Site
Columbus, Ohio, United States, 43213
Novartis Investigator Site
Marion, Ohio, United States, 43302
John Winder Associates
Sylvania, Ohio, United States, 43650
Advanced Health Care Specialists
Thornville, Ohio, United States, 43076
The University of Toledo
Toledo, Ohio, United States, 43614
Pharmacotherapy Research Associates, Inc
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Lynne Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Allergy and Asthma Clinic
Oklahoma City, Oklahoma, United States, 73104
Healthcare Research Consultants, Inc
Tulsa, Oklahoma, United States, 74135
United States, Oregon
River Road Medical Group
Eugene, Oregon, United States, 97404
Oregon Clinical Research Associates
Medford, Oregon, United States, 97504
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States, 97504
Allergy Associates Research Center
Portland, Oregon, United States, 97213
Novartis Investigator Site
Portland, Oregon, United States, 97227-1110
United States, Pennsylvania
Tri-State Medical Group
Beaver, Pennsylvania, United States, 15009 - 1957
Novartis Investigator Site
Easton, Pennsylvania, United States, 18045
Chest Diseases of Northwestern PA
Erie, Pennsylvania, United States, 16506
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19107
Asthma Allergy &Pulmonary Associates, PC
Philadelphia, Pennsylvania, United States, 19107
Novartis Investigator Site
Philadelphia, Pennsylvania, United States, 19141
Novartis Investigator Site
Philadelphia, Pennsylvania, United States, 19140
South Hills Pulmonary Associates
Pittsburgh, Pennsylvania, United States, 15243
Pittsburgh Pulmonary Associates
Pittsburgh, Pennsylvania, United States, 15025
United States, Rhode Island
New England Center for Clinical Research
Cranston, Rhode Island, United States, 02920
Partners in Clinical Research
Cumberland, Rhode Island, United States, 02864
United States, South Carolina
Hugh D. Durrence, MD, Family Medicine
Charleston, South Carolina, United States, 29412
Low County Lung and Critical Care, PA
Charleston, South Carolina, United States, 29406-7108
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Med Plus South - Strand Family Practice
Garden City, South Carolina, United States, 29576
Novartis Investigator Site
Greenville, South Carolina, United States, 29615
Spartanburg Pharmaceutical Research
Spartanburg, South Carolina, United States, 29303
Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab
Varnville, South Carolina, United States, 29944
United States, Tennessee
MultiSpeciality Clinical Research
Johnson City, Tennessee, United States, 37601
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Volunteer Research Center
Knoxville, Tennessee, United States, 37920
Dickson Family Medicine Group, PC
Nashville, Tennessee, United States, 37203
Novartis Investigator Site
Nashville, Tennessee, United States, 37208-3599
Heartland Medical, P.C
New Tazewell, Tennessee, United States, 37825-1409
United States, Texas
PharmaTex Research LLC
Amarillo, Texas, United States, 79106
Trinity Clinic - Corsicana
Corsicana, Texas, United States, 75110
Asthma & Allergy Research Associates
Dallas, Texas, United States, 75231
Pharmaceutical Research & Consulting, Inc
Dallas, Texas, United States, 75231-4307
Western Sky Medical Research
El Paso, Texas, United States, 79902
Texas Pulmonary & Critical Care
Ft. Worth, Texas, United States, 76104
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555 - 0561
*Private Practice*
Houston, Texas, United States, 77024
Baylor College of Medicine
Houston, Texas, United States, 77030
Houstons Veteran's Medical Center
Houston, Texas, United States, 77030
West Houston Allergy and Asthma, PA
Katy, Texas, United States, 77450
Central Texas Health Research
New Braunfels, Texas, United States, 78130
Audie L. Murphy VA Hospital
San Antonio, Texas, United States, 78229 - 4404
Allergy and Asthma Research Center, PA
San Antonio, Texas, United States, 78229
Diagnostics Research Group
San Antonio, Texas, United States, 78229
Wellmed Clinical Research
San Antonio, Texas, United States, 78229
Quality Assurance Research Centre
San Antonio, Texas, United States, 78205
United States, Vermont
Vermont Lung Center
Colchester, Vermont, United States, 05446
United States, Virginia
Johnston Memorial Hospital Pulmonary Research
Abingdon, Virginia, United States, 24210
University of Virginia
Charlottesville, Virginia, United States, 22908
Lynchburg Pulmonary Associates
Lynchburg, Virginia, United States, 24501
Novartis Investigator Site
Richmond, Virginia, United States, 23249
United States, Washington
Madrona Medical Group - Clinical Research Dept.
Bellingham, Washington, United States, 98226
William L. Gray Research
Spokane, Washington, United States, 99216
Pulmonary and Research Associates
Spokane, Washington, United States, 99204
Madigan Army medical Center / Dept. of Army
Tacoma, Washington, United States, 98431
Pulmonary Consultants, PLLC
Tacoma, Washington, United States, 98405
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 26304
United States, Wisconsin
Novartis Investigator Site
Milwaukee, Wisconsin, United States, 53209
Argentina
Novartis
Buenos Aires, Argentina
Novartis Investigator Site
Buenos Aires, Argentina
Novartis Investigator Site
Capital Federal, Argentina
Novartis Investigator Site
Santa Fe, Argentina
Canada
Novartis Investigator Site
Ajax, Canada
Novartis Investigator Site
Calgary, Canada
Novartis Investigator Site
Chatham, Canada
Novartis Investigator Site
Gatineau, Canada
Novartis Investigator Site
Moncton, Canada
Novartis Investigator Site
Montreal, Canada
Novartis Investigator Site
Niagara Falls, Canada
Novartis Investigator Site
Ottawa, Canada
Novartis
Quebec, Canada
Novartis Investigator Site
Saskatoon, Canada
Novartis Investigator Site
Sherbrooke, Canada
Novartis Investigator Site
St John, Canada
Novartis Investigator Site
St John's, Canada
Novartis Investigator Site
St Romuald, Canada
Novartis Investigator Site
Ste-Foy, Canada
Novartis Investigator Site
Toronto, Canada
Novartis Investigator Site
Trois-Rivieres, Canada
Novartis Investigator Site
Vancouver, Canada
Novartis Investigator Site
Waterloo, Canada
Novartis Investigator Site
Windsor, Canada
Novartis Investigator Site
Winnipeg, Canada
Germany
Novartis Investigator Site
Augsburg, Germany
Novartis Investigator Site
Bad Segeberg, Germany
Novartis Investigator Site
Berlin, Germany
Novartis Investigator Site
Bielefeld, Germany
Novartis Investigator Site
Bonn, Germany
Novartis Investigator Site
Bruhl, Germany
Novartis Investigator Site
Dachau, Germany
Novartis
Fuerth, Germany
Novartis Investigator Site
Hamburg, Germany
Novartis Investigator Site
Hoyerswerda, Germany
Novartis Investigator Site
Kaufbeuren, Germany
Novartis Investigator Site
Landsberg, Germany
Novartis Investigator Site
Leipzig, Germany
Novartis Investigator Site
Mainz, Germany
Novartis Investigator Site
Muenchen, Germany
Novartis Investigator Site
Oranienburg, Germany
Novartis Investigator Site
Oschersleben, Germany
Novartis Investigator Site
Potsdam, Germany
Novartis Investigator Site
Ratingen, Germany
Novartis Investigator Site
Steinfurt, Germany
Novartis Investigator Site
Wuppertal, Germany
India
Novartis Investigator Site
Bangalore, India
Novartis Investigator Site
Banglore, India
Novartis Investigator Site
Caranazalem, India
Novartis Investigator Site
Chennai, India
Novartis Investigator Site
Coimbatore, India
Novartis Investigator Site
Hyderabaad, India
Novartis Investigator Site
Indore, India
Novartis Investigator Site
Jaipur, India
Novartis Investigator Site
Kolkatta, India
Novartis Investigator Site
Ludhiana, India
Novartis Investigator Site
Mumbai, India
Novartis Investigator Site
Trivandrum, India
Italy
Novartis Investigator Site
Bologna, Italy
Novartis Investigator Site
Busto Arsizio, Italy
Novartis Investigator Site
Catania, Italy
Novartis Investigator Site
Catanzaro, Italy
Novartis Investigator Site
Chioggia, Italy
Novartis Investigator Site
Crema, Italy
Novartis Investigator Site
Ferrara, Italy
Novartis Investigator Site
Firenze, Italy
Novartis Investigator Site
Genova, Italy
Novartis Investigator Site
Messina, Italy
Novartis Investigator Site
Milano, Italy
Novartis
Milano, Italy
Novartis Investigator Site
Pisa, Italy
Novartis Investigator Site
Roma, Italy
Novartis Investigator Site
Rozzano, Italy
Novartis Investigator Site
Siena, Italy
Korea, Republic of
Novartis Investigator Site
Bucheon, Korea, Republic of
Novartis Investigator Site
Busan, Korea, Republic of
Novartis Investigator Site
Chuncheon, Korea, Republic of
Novartis Investigator Site
Daegu, Korea, Republic of
Novartis Investigator Site
Kwangju, Korea, Republic of
Novartis Investigator Site
Seoul, Korea, Republic of
Novartis
Seoul, Korea, Republic of
Novartis Investigator Site
Suwon, Korea, Republic of
Novartis Investigator Site
Wonju, Korea, Republic of
Puerto Rico
Novartis Investigator Site
Ponce, Puerto Rico, 716
Spain
Novartis Investigator Site
Alicante, Spain
Novartis
Barcelona, Spain
Novartis Investigator Site
Barcelona, Spain
Novartis Investigator Site
Burgos, Spain
Novartis Investigator Site
Cadiz, Spain
Novartis Investigator Site
Calde Lugo, Spain
Novartis Investigator Site
Galdakano, Spain
Novartis Investigator Site
Gerona, Spain
Novartis Investigator Site
Gran Canaria, Spain
Novartis Investigator Site
La Coruna, Spain
Novartis Investigator Site
Madrid, Spain
Novartis Investigator Site
Malaga, Spain
Novartis Investigator Site
Orense, Spain
Novartis Investigator Site
Oviedo, Spain
Novartis Investigator Site
Palma de Mallorca, Spain
Novartis Investigator Site
Ponferrada, Spain
Novartis Investigator Site
Pontevedra, Spain
Novartis Investigator Site
Puerto de Sagunto, Spain
Novartis Investigator Site
Sevilla, Spain
Novartis Investigator Site
Valencia, Spain
Novartis Investigator Site
Vic, Spain
Novartis Investigator Site
Vila-Real, Spain
Novartis Investigator Site
Zaragoza, Spain
Sweden
Novartis
Goteborg, Sweden
Novartis Investigator Site
Jonkoping, Sweden
Novartis Investigator Site
Lidingo, Sweden
Novartis Investigator Site
Lulea, Sweden
Novartis Investigator Site
Lund, Sweden
Taiwan
Novartis Investigator Site
Chiayi, Taiwan
Novartis Investigator Site
LinKou, Taiwan
Novartis Investigator Site
Taichung, Taiwan
Novartis Investigator Site
Taipei, Taiwan
Novartis
Taipei, Taiwan
Turkey
Novartis Investigator Site
Anakara, Turkey
Novartis
Istanbul, Turkey
Novartis Investigator Site
Izmir, Turkey
Novartis Investigator Site
Konya, Turkey
Novartis Investigator Site
Manisa, Turkey
Novartis Investigator Site
Mersin, Turkey
Novartis Investigator Site
Yenisehir, Turkey
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: external affairs, Novartis
ClinicalTrials.gov Identifier: NCT00463567     History of Changes
Other Study ID Numbers: CQAB149B2335S
Study First Received: April 19, 2007
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Italy: Direzione Generale di Sanità Veterinaria e degli Alimenti
Korea: Food and Drug Administration
United States: Food and Drug Administration
Taiwan: Department of Health
India: Institutional Review Board
Sweden: Medical Products Agency
Turkey: Ministry of Health
Venezuela: Intituto Nacional de Higiene Rafael Rangel

Keywords provided by Novartis:
indacaterol
long acting beta-2 agonist

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Formoterol
Tiotropium
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on April 17, 2014