ClinicalTrials.gov record
26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT00463567
Public ClinicalTrials.gov record NCT00463567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00463567
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 2,059 participants
Conditions and interventions
Interventions
- Indacaterol Drug
- Formoterol (12 µg b.i.d.) Drug
- Tiotropium (18 µg o.d.) Drug
- Placebo to Indacaterol Drug
- Placebo to Formoterol Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2007
- Primary completion
- Jul 31, 2008
- Completion
- Jul 31, 2008
- Last update posted
- Aug 17, 2011
2007 – 2008
United States locations
- U.S. sites
- 221
- U.S. states
- 42
- U.S. cities
- 166
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| Pulmonary Medicine Associates PC | Homewood | Alabama | 35209 | — |
| Jasper Summit Research | Jasper | Alabama | 35501 | — |
| Pulmonary Associate of Mobile, PC | Mobile | Alabama | 36608 | — |
| Pulmonary Associates, PA | Glendale | Arizona | 85306 | — |
| Pulmonary Associates, PA | Phoenix | Arizona | 85006 | — |
| Novartis Investigative Center | Scottsdale | Arizona | 85255 | — |
| Arizona Pulmonary Specialists, LTD | Scottsdale | Arizona | 85258 | — |
| Premiere Pharmaceutical Research, LLC | Tempe | Arizona | 85282 | — |
| Canyon Clinical Research, LLC | Tucson | Arizona | 85712 | — |
| SAVAHSC / Pulmonary Section | Tucson | Arizona | 85723 | — |
| Novartis Investigator Site | Pine Bluff | Arkansas | 71603 | — |
| Novartis Investigator Site | Buena Park | California | 90620 | — |
| USC Rancho Amigos Medical Center | Downey | California | 90242 | — |
| Encompass Clinical Research - North Coast | Encinitas | California | 92024 | — |
| California Research | Fullerton | California | 92835 | — |
| Allergy and Asthma Specialists Medical Group and research Center | Huntington Beach | California | 92647 | — |
| Interlink Research Institute | Los Alamitos | California | 90720 | — |
| Allergy Research Foundation, Inc | Los Angeles | California | 90025 | — |
| Novartis Investigator Site | Los Angeles | California | 90033 | — |
| Southern California Institute for Respiratory Diseases | Los Angeles | California | 90048 | — |
| David Geffen UCLA School of Medicine | Los Angeles | California | 90095 | — |
| Advance Clinical Research Institute | Orange | California | 92869 | — |
| California Allergy & Asthma Medical Group | Palmdale | California | 93551 | — |
| Intergrated Research Group | Riverside | California | 92506 | — |
| Allergy & Asthma Associates of Santa Clara Res. Center | San Jose | California | 95117 | — |
| Greater Los Angeles Healthcare System | Sepulveda | California | 91343 | — |
| Encompass Clinical Research | Spring Valley | California | 91978 | — |
| Bensch Clinical Research Associates | Stockton | California | 95207 | — |
| Peninsula Pulmonary Medical Associates | Torrance | California | 90505 | — |
| Progressive Clinical Research | Vista | California | 92083 | — |
| Allergy and Asthma Clinical Research Inc | Walnut Creek | California | 94598 | — |
| Boulder Medical Center | Boulder | Colorado | 80304 | — |
| National Jewish Medical & Research Center | Denver | Colorado | 80206 | — |
| Northern Colorado Pulmonary Consultants, PC | Fort Collins | Colorado | 80528 | — |
| New West Physicians Clinical research | Golden | Colorado | 80401 | — |
| Rocky Mountain Center for Clinical Research | Wheat Ridge | Colorado | 80033 | — |
| Western States Clinical Research | Wheat Ridge | Colorado | 80033 | — |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | — |
| Lung Health & Sleep Enhancement Center | Newark | Delaware | 19713 | — |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | — |
| University of Florida Shands Hospital | Gainesville | Florida | 32610 - 0277 | — |
| Shands Jacksonville Medical Center | Jacksonville | Florida | 32209 | — |
| Innovative Research of West Florida | Largo | Florida | 33770 | — |
| University of Miami School of Medicine | Miami | Florida | 33136 | — |
| Elite Research Institute | Miami | Florida | 33169 | — |
| Novartis Investigator Site | Pembroke Pines | Florida | 33029 | — |
| Emerald Coast Clinical Research, LLC | Pensacola | Florida | 32504 | — |
| Pensacola Research Consultants | Pensacola | Florida | 32504 | — |
| Integrity Research | Pensacola | Florida | 32514 | — |
| Brevard Pulmonary Specialists | Rockledge | Florida | 32955 | — |
| Asthma & Allergy Research Center | Sarasota | Florida | 34233 | — |
| South Miami Clinical Research, LLC | South Miami | Florida | 33143 | — |
| Central Medical Group, PA | Tamarac | Florida | 33321 | — |
| Clireco, Inc | Tamarac | Florida | 33321 | — |
| Novartis Investigator Site | Tampa | Florida | 33603 | — |
| University of South Florida | Tampa | Florida | 33613 | — |
| Neutrotrials Research Inc | Atlanta | Georgia | 30342 | — |
| Georgia Clinical Research | Austell | Georgia | 30106 | — |
| Marietta Pulmonary Medicine | Marietta | Georgia | 30060 | — |
| University of Chicago Hospital | Chicago | Illinois | 60637 | — |
| Sneeze, Wheeze & Itch Associates, LLC | Normal | Illinois | 61761 | — |
| Southern Illinois Clinical Research Center | O'Fallon | Illinois | 62269 | — |
| Novartis Investigator Site | River Forest | Illinois | 60305 | — |
| Community Hospital Anderson | Anderson | Indiana | 46011 | — |
| Dawes Fretzin Clinical Research Group LLC | Indianapolis | Indiana | 46256 | — |
| South Bend Clinic | South Bend | Indiana | 46617 | — |
| Iowa Clinical Research Corporation | Iowa City | Iowa | 52240 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Heart of America Research Institute | Shawnee Mission | Kansas | 66216 | — |
| Cotton-O'Neil Clinical Research Center | Topeka | Kansas | 66606 | — |
| Novartis Investigator Site | Crescent Springs | Kentucky | 41017 | — |
| Kentucky Medical research Center | Lexington | Kentucky | 40504 | — |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | — |
| Family Asthma and Allergy Research Associates | Louisville | Kentucky | 40215 | — |
| Gulf Coast Research, LLC | Lafayette | Louisiana | 70503 | — |
| Rx R&D | Metaire | Louisiana | 70002 | — |
| LSU Health Sciences Center/LSU School of Medicine | New Orleans | Louisiana | 70112 | — |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | — |
| Louisiana Health Sciences Center | Shreveport | Louisiana | 71103 | — |
| Northshore Research Associates | Slidell | Louisiana | 70461 | — |
| Allergy, Asthma, Immunology, Pharmaceutical Studies | Bangor | Maine | 04401 | — |
| Primecare Physician Associates | Biddeford | Maine | 04005 | — |
| John Hopkins Asthma and Allergy Center | Baltimore | Maryland | 21224 | — |
| Miray Medical Center | Brockton | Massachusetts | 02302 | — |
| Fallon Clinic at Worcester Medical Center | Worcester | Massachusetts | 01604 | — |
| ClinSite, Inc | Ann Arbor | Michigan | 48106-0525 | — |
| Novartis Investigator Site | Clarkston | Michigan | 48346 | — |
| Harper University Hospital; Wayne State University | Detroit | Michigan | 48201 | — |
| Novartis Investigator Site | Flint | Michigan | 48532 | — |
| Pulmonary Respiratory Institute of Southwest Michigan | Livonia | Michigan | 48152 | — |
| Novartis Investigator Site | Port Huron | Michigan | 48060 | — |
| Synergy Medical Education Alliance | Saginaw | Michigan | 48602 - 5303 | — |
| Novartis Investigator Site | Troy | Michigan | 48085 | — |
| Minnesota Lung Center | Edina | Minnesota | 55435 | — |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | — |
| Novartis Investigator Site | Minneapolis | Minnesota | 55402 | — |
| Minnesota Lung Center | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| St. Luke's Cardio-Pulmonary Research | Chesterfield | Missouri | 63017 | — |
| University of Missouri - Columbia | Columbia | Missouri | 65212 | — |
| Kansas City University of Medicine and Biosciences | Kansas City | Missouri | 64106 - 1453 | — |
| University of Missouri KC/ Truman Medical | Kansas City | Missouri | 64108-2677 | — |
| Midwest Chest Consultants | Saint Charles | Missouri | 63301 | — |
| Washington U School of Medicine, Center for Clinical Studies | St Louis | Missouri | 63110 | — |
| The Clinical Research Centre | St Louis | Missouri | 63141 | — |
| Montana Health Research Institute | Billings | Montana | 59102 | — |
| Novartis Investigator Site | Kalispell | Montana | 59901 | — |
| Novartis Investigator Site | Missoula | Montana | 59808 | — |
| Somnos Laboratories, Inc | Lincoln | Nebraska | 68510 | — |
| Omaha VA Medical Center | Omaha | Nebraska | 68105 | — |
| Quality Clinical Research | Omaha | Nebraska | 68114 | — |
| Midwest Allergy and Asthma Clinic | Omaha | Nebraska | 68130 | — |
| Creighton University Centre for Allergy, Asthma & Immunology | Omaha | Nebraska | 68131 | — |
| Creigton University | Omaha | Nebraska | 68131 | — |
| Heartland Clinical Research, Inc | Omaha | Nebraska | 68134 | — |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| University of Nebraska Medical Center - Pulmonary Research | Omaha | Nebraska | 68198 - 5885 | — |
| The Asthma & Allergy Center, PC | Papillion | Nebraska | 68046 | — |
| Lovelace Scientific Resources, Inc. | Henderson | Nevada | 89014 | — |
| Clinical Research Center of NV | Las Vegas | Nevada | 89131 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Delaware Valley Clinical Research | Cherry Hill | New Jersey | 08003 | — |
| Pulmonary and Critical Care Associates, PA | East Brunswick | New Jersey | 08816 | — |
| Novartis Investigator Site | Newark | New Jersey | 7101 | — |
| Pulmonary and Allergy Associates, PA | Summit | New Jersey | 07901 | — |
| Pulmonary and Critical Care Services | Albany | New York | 12205 | — |
| Crescent Medical Associates | Astoria | New York | 11102 | — |
| Asthma and Allergy Associates | Cortland | New York | 13045 | — |
| Asthma and Allergy Associates | Elmira | New York | 14905 | — |
| Nassau Chest Physicians, PC | Massapequa | New York | 11758 | — |
| North Shore University Hospital | New Hyde Park | New York | 11040 | — |
| New York Pulmonary Associates, PC | New York | New York | 10016 | — |
| Weill Medical College of Cornell University | New York | New York | 10021 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| AAIR research Centre | Rochester | New York | 14618 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Sensenbrenner Primary Care | Charlotte | North Carolina | 28277 | — |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | — |
| Novartis Investigator Site | Shelby | North Carolina | 28150 | — |
| Cloverdale Research Facility | Winston-Salem | North Carolina | 27103 | — |
| Merit Care Medical Group | Fargo | North Dakota | 58122 | — |
| Cincinnati VA Hospital | Cincinnati | Ohio | 45220 | — |
| New Horizons Clinical Research | Cincinnati | Ohio | 452242 | — |
| Bernstein Clinical Research Centre | Cincinnati | Ohio | 45231 | — |
| Community Research Inc | Cincinnati | Ohio | 45245 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Metro Health Medical Center | Cleveland | Ohio | 44109-1998 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio State University - Davis Heart and Lung Research Institute | Columbus | Ohio | 43210 | — |
| Novartis Investigator Site | Columbus | Ohio | 43213 | — |
| Remington-Davis Clinical Research | Columbus | Ohio | 43215 | — |
| Novartis Investigator Site | Columbus | Ohio | 43235 | — |
| Novartis Investigator Site | Marion | Ohio | 43302 | — |
| John Winder Associates | Sylvania | Ohio | 43650 | — |
| Advanced Health Care Specialists | Thornville | Ohio | 43076 | — |
| The University of Toledo | Toledo | Ohio | 43614 | — |
| Pharmacotherapy Research Associates, Inc | Zanesville | Ohio | 43701 | — |
| Oklahoma Allergy and Asthma Clinic | Oklahoma City | Oklahoma | 73104 | — |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | — |
| Lynne Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Healthcare Research Consultants, Inc | Tulsa | Oklahoma | 74135 | — |
| River Road Medical Group | Eugene | Oregon | 97404 | — |
| Clinical Research Institute of Southern Oregon, PC | Medford | Oregon | 97504 | — |
| Oregon Clinical Research Associates | Medford | Oregon | 97504 | — |
| Allergy Associates Research Center | Portland | Oregon | 97213 | — |
| Novartis Investigator Site | Portland | Oregon | 97227-1110 | — |
| Tri-State Medical Group | Beaver | Pennsylvania | 15009 - 1957 | — |
| Novartis Investigator Site | Easton | Pennsylvania | 18045 | — |
| Chest Diseases of Northwestern PA | Erie | Pennsylvania | 16506 | — |
| Asthma Allergy &Pulmonary Associates, PC | Philadelphia | Pennsylvania | 19107 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19107 | — |
| Novartis Investigator Site | Philadelphia | Pennsylvania | 19140 | — |
| Novartis Investigator Site | Philadelphia | Pennsylvania | 19141 | — |
| Pittsburgh Pulmonary Associates | Pittsburgh | Pennsylvania | 15025 | — |
| South Hills Pulmonary Associates | Pittsburgh | Pennsylvania | 15243 | — |
| New England Center for Clinical Research | Cranston | Rhode Island | 02920 | — |
| Partners in Clinical Research | Cumberland | Rhode Island | 02864 | — |
| Low County Lung and Critical Care, PA | Charleston | South Carolina | 29406-7108 | — |
| Hugh D. Durrence, MD, Family Medicine | Charleston | South Carolina | 29412 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Med Plus South - Strand Family Practice | Garden City | South Carolina | 29576 | — |
| Novartis Investigator Site | Greenville | South Carolina | 29615 | — |
| Spartanburg Pharmaceutical Research | Spartanburg | South Carolina | 29303 | — |
| Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab | Varnville | South Carolina | 29944 | — |
| MultiSpeciality Clinical Research | Johnson City | Tennessee | 37601 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Volunteer Research Center | Knoxville | Tennessee | 37920 | — |
| Dickson Family Medicine Group, PC | Nashville | Tennessee | 37203 | — |
| Novartis Investigator Site | Nashville | Tennessee | 37208-3599 | — |
| Heartland Medical, P.C | New Tazewell | Tennessee | 37825-1409 | — |
| PharmaTex Research LLC | Amarillo | Texas | 79106 | — |
| Trinity Clinic - Corsicana | Corsicana | Texas | 75110 | — |
| Pharmaceutical Research & Consulting, Inc | Dallas | Texas | 75231-4307 | — |
| Asthma & Allergy Research Associates | Dallas | Texas | 75231 | — |
| Western Sky Medical Research | El Paso | Texas | 79902 | — |
| Texas Pulmonary & Critical Care | Fort Worth | Texas | 76104 | — |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 - 0561 | — |
| *Private Practice* | Houston | Texas | 77024 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Houstons Veteran's Medical Center | Houston | Texas | 77030 | — |
| West Houston Allergy and Asthma, PA | Katy | Texas | 77450 | — |
| Central Texas Health Research | New Braunfels | Texas | 78130 | — |
| Quality Assurance Research Centre | San Antonio | Texas | 78205 | — |
| Audie L. Murphy VA Hospital | San Antonio | Texas | 78229 - 4404 | — |
| Allergy and Asthma Research Center, PA | San Antonio | Texas | 78229 | — |
| Diagnostics Research Group | San Antonio | Texas | 78229 | — |
| Wellmed Clinical Research | San Antonio | Texas | 78229 | — |
| Vermont Lung Center | Colchester | Vermont | 05446 | — |
| Johnston Memorial Hospital Pulmonary Research | Abingdon | Virginia | 24210 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Lynchburg Pulmonary Associates | Lynchburg | Virginia | 24501 | — |
| Novartis Investigator Site | Richmond | Virginia | 23249 | — |
| Madrona Medical Group - Clinical Research Dept. | Bellingham | Washington | 98226 | — |
| Pulmonary and Research Associates | Spokane | Washington | 99204 | — |
| William L. Gray Research | Spokane | Washington | 99216 | — |
| Pulmonary Consultants, PLLC | Tacoma | Washington | 98405 | — |
| Madigan Army medical Center / Dept. of Army | Tacoma | Washington | 98431 | — |
| Charleston Area Medical Center | Charleston | West Virginia | 26304 | — |
| Novartis Investigator Site | Milwaukee | Wisconsin | 53209 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 123 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00463567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 17, 2011 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00463567 live on ClinicalTrials.gov.