COPD Clinical Trial
Official title:
Dose-Ranging Study in Patients With COPD
| Verified date | October 2011 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The trial is designed to identify an appropriate dose of QAB149 for delivery via a multiple dose inhaler for use in the COPD Phase III program.
| Status | Completed |
| Enrollment | 686 |
| Est. completion date | December 2004 |
| Est. primary completion date | December 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of COPD - Age 40-75 years - Smoking history Exclusion Criteria: - Other serious disease - Allergy to QAB149 - Respiratory tract infection |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | ClinSite, Inc. | Ann Arbor | Michigan |
| United States | University of Michigan Health System | Ann Arbor | Michigan |
| United States | University Medical Associates, LLP | Augusta | Georgia |
| United States | Radiant Research - Atlanta West | Austell | Georgia |
| United States | Madrona Medical Group | Bellingham | Washington |
| United States | UAB Pulmonary Research | Birmingham | Alabama |
| United States | St. Elizabeth's Medical Center | Brighton | Massachusetts |
| United States | University of Noth Carolina--Pulmonary Division | Chapel Hill | North Carolina |
| United States | Low Country Lung and Critical Care | Charleston | South Carolina |
| United States | Asthma & Allergy Res. Associates | Dallas | Texas |
| United States | USC Rancho Amigos Medical Center | Downey | California |
| United States | Radiant Research | Encinitas | California |
| United States | River Road Medical Group | Eugene | Oregon |
| United States | Physician's Research Center | Hartford | Connecticut |
| United States | Pulmonary Respiratory Institute of Southeast Michigan | Livonia | Michigan |
| United States | Allergy Research Foundation , Inc | Los Angeles | California |
| United States | David Geffin UCLA School of Medicine | Los Angeles | California |
| United States | University of Miami School of Medicine | Miami | Florida |
| United States | Clinical Research Institute | Minneapolis | Minnesota |
| United States | Minnesota Lung Center | Minneapolis | Minnesota |
| United States | Southern California Research | Mission Viejo | California |
| United States | Diagnostic & Medical Clinic | Mobile | Alabama |
| United States | The University of South Alabama Medical Center | Mobile | Alabama |
| United States | Central Texas Health Research | New Baunfels | Texas |
| United States | New Orleans Center for Clinical Research | New Orleans | Louisiana |
| United States | Sneeze, Wheeze & Itch Associates, LLC | Normal | Illinois |
| United States | New England Clinical Research | North Dartmouth | New Hampshire |
| United States | Oklahoma Allergy and Asthma Clinic | Oklahoma City | Oklahoma |
| United States | VA Medical Center | Oklahoma City | Oklahoma |
| United States | Creigton University | Omaha | Nebraska |
| United States | Univ. of Nebraska Medical Center--Pulmonary Research | Omaha | Nebraska |
| United States | California Allergy & Asthma Medical Group | Palmdale | California |
| United States | Cordova Medical Center | Pensacola | Florida |
| United States | Crescent Clinical Research | Pensacola | Florida |
| United States | Pulmonary Associates | Phoenix | Arizona |
| United States | Allergy Associates Research Center | Portland | Oregon |
| United States | North Carolina Clinical Research | Raleigh | North Carolina |
| United States | Asthma and Allergy Center of Chicago S.C. | River Forest | Illinois |
| United States | AAIR Reseach Center | Rochester | New York |
| United States | Sylvana Research | San Antonio | Texas |
| United States | Allergy Associates Medical Group, Inc | San Diego | California |
| United States | Allergy & Asthma Associates of Santa Clara Research Center | San Jose | California |
| United States | Upstate Pharmaceutical Research | Simpsonville | South Carolina |
| United States | Princeton Center for Clinical Research | Skillman | New Jersey |
| United States | Pulmonary & Allergy Associates | Springfield | New Jersey |
| United States | The Clinical Research Center | St. Louis | Missouri |
| United States | Bensch Clinical Research Associates | Stockton | California |
| United States | Pulmonary Consultants, PLLC | Tacoma | Washington |
| United States | USF Asthma, Allergy & Immunology, Clinical Research Unit | Tampa | Florida |
| United States | Center for Clinical Research | Tauton | Massachusetts |
| United States | Healthcare Research Consultants Inc. | Tulsa | Oklahoma |
| United States | Trinity Clinic Office of Research Admin. | Tyler | Texas |
| United States | Rocky Mountain Center for Clinical Research | Wheat Ridge | Colorado |
| United States | Cloverdale Research Facility | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pulmonary function measured between 22 and 24 hours after dosing on Day 1 | |||
| Secondary | Pulmonary function measured on days 1 and 7 at various intervals after dosing | |||
| Secondary | Safety measurements |
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