RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative
Who is this study for? Patients with Chronic Obstructive Pulmonary Disease
What treatments are being studied? Indacaterol/Glycopyrrolate
Status: Completed
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study hypothesis is that symptomatic current and former smokers with spirometric values within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC ≥ 70% predicted will still derive symptomatic benefit from long-acting bronchodilator therapy even though they are excluded from current GOLD guideline recommendations.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:
• Subject must be able to understand and provide informed consent
• Age 40-80
• ≥10 pack-year smoking history
• Post-bronchodilator FEV1/FVC ratio ≥0.70
• Baseline CAT≥10
Locations
United States
Alabama
Universityof Alabama
Birmingham
California
University of California
Los Angeles
University of California
San Francisco
LABIOMED at Harbor-UCLA Medical Center
Torrance
Iowa
University of Iowa
Iowa City
Illinois
Northwestern University
Chicago
University of Illinois
Chicago
Maryland
Johns Hopkins University
Baltimore
Michigan
University of Michigan
Ann Arbor
Minnesota
Minneapolis VA Medical Center
Minneapolis
Minnesota Health partners
Saint Paul
North Carolina
Duke University
Durham
New York
Cornell University
New York
Pennsylvania
Temple University
Philadelphia
University of Pittsburgh
Pittsburgh
Utah
University of Utah
Salt Lake City
Time Frame
Start Date: 2017-08-29
Completion Date: 2021-07-07
Participants
Target number of participants: 780
Treatments
Active_comparator: Indacaterol/Glycopyrrolate
indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily for 12 weeks
Placebo_comparator: Placebo
Placebo 27.5/15.6 mcg inhaled twice daily for 12 weeks
Authors
Related Therapeutic Areas
Sponsors
Leads: University of Michigan
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)