Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
686
1 country
54
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
Shorter than P25 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 3, 2004
CompletedFirst Posted
Study publicly available on registry
December 6, 2004
CompletedOctober 25, 2011
October 1, 2011
5 months
December 3, 2004
October 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulmonary function measured between 22 and 24 hours after dosing on Day 1
Secondary Outcomes (2)
Pulmonary function measured on days 1 and 7 at various intervals after dosing
Safety measurements
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD
- Age 40-75 years
- Smoking history
You may not qualify if:
- Other serious disease
- Allergy to QAB149
- Respiratory tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
UAB Pulmonary Research
Birmingham, Alabama, 35294-0012, United States
Diagnostic & Medical Clinic
Mobile, Alabama, 36607, United States
The University of South Alabama Medical Center
Mobile, Alabama, 36688, United States
Pulmonary Associates
Phoenix, Arizona, 85006, United States
USC Rancho Amigos Medical Center
Downey, California, 90242, United States
Radiant Research
Encinitas, California, 92024, United States
Allergy Research Foundation , Inc
Los Angeles, California, 90025, United States
David Geffin UCLA School of Medicine
Los Angeles, California, 90095, United States
Southern California Research
Mission Viejo, California, 92691, United States
California Allergy & Asthma Medical Group
Palmdale, California, 93551, United States
Allergy Associates Medical Group, Inc
San Diego, California, 921120, United States
Allergy & Asthma Associates of Santa Clara Research Center
San Jose, California, 95117-1780, United States
Bensch Clinical Research Associates
Stockton, California, 95207, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033, United States
Physician's Research Center
Hartford, Connecticut, 06106, United States
University of Miami School of Medicine
Miami, Florida, 33101, United States
Crescent Clinical Research
Pensacola, Florida, 32503, United States
Cordova Medical Center
Pensacola, Florida, 32504, United States
USF Asthma, Allergy & Immunology, Clinical Research Unit
Tampa, Florida, 33613, United States
University Medical Associates, LLP
Augusta, Georgia, 30901, United States
Radiant Research - Atlanta West
Austell, Georgia, 30106, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, 61761, United States
Asthma and Allergy Center of Chicago S.C.
River Forest, Illinois, 60305, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70118, United States
St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
Center for Clinical Research
Tauton, Massachusetts, 02780, United States
ClinSite, Inc.
Ann Arbor, Michigan, 48106-0525, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Pulmonary Respiratory Institute of Southeast Michigan
Livonia, Michigan, 48152, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Minnesota Lung Center
Minneapolis, Minnesota, 55407, United States
The Clinical Research Center
St Louis, Missouri, 63141, United States
Creigton University
Omaha, Nebraska, 68131, United States
Univ. of Nebraska Medical Center--Pulmonary Research
Omaha, Nebraska, 68198, United States
New England Clinical Research
North Dartmouth, New Hampshire, 02747, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
Pulmonary & Allergy Associates
Springfield, New Jersey, 07081, United States
AAIR Reseach Center
Rochester, New York, 14518, United States
University of Noth Carolina--Pulmonary Division
Chapel Hill, North Carolina, 27599, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Cloverdale Research Facility
Winston-Salem, North Carolina, 27157, United States
Oklahoma Allergy and Asthma Clinic
Oklahoma City, Oklahoma, 73104, United States
VA Medical Center
Oklahoma City, Oklahoma, 73104, United States
Healthcare Research Consultants Inc.
Tulsa, Oklahoma, 74135, United States
River Road Medical Group
Eugene, Oregon, 97404, United States
Allergy Associates Research Center
Portland, Oregon, 97213, United States
Low Country Lung and Critical Care
Charleston, South Carolina, 29406-7108, United States
Upstate Pharmaceutical Research
Simpsonville, South Carolina, 29681, United States
Asthma & Allergy Res. Associates
Dallas, Texas, 75231, United States
Central Texas Health Research
New Baunfels, Texas, 78130, United States
Sylvana Research
San Antonio, Texas, 78229, United States
Trinity Clinic Office of Research Admin.
Tyler, Texas, 75702, United States
Madrona Medical Group
Bellingham, Washington, 98226, United States
Pulmonary Consultants, PLLC
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
Novartis East Hanover
862-778-8300
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 3, 2004
First Posted
December 6, 2004
Study Start
July 1, 2004
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
October 25, 2011
Record last verified: 2011-10