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:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00463567
First received: April 19, 2007
Last updated: July 22, 2011
Last verified: July 2011
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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:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Formoterol fumarate
Formoterol
Tiotropium bromide
Arformoterol Tartrate
Indacaterol
U.S. FDA Resources
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
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| 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 May 16, 2013