Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 1
Recruiting in Palo Alto (17 mi)
+49 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Boehringer Ingelheim
Prior Safety Data
Trial Summary
What is the purpose of this trial?
A randomized, placebo-controlled, double-blind, parallel group, multi center study to assess the safety and efficacy of tiotropium bromide (18 µg) delivered via the HandiHaler® in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation (Hospital Discharge 1)
Research Team
BI
Boehringer Ingelheim
Principal Investigator
Boehringer Ingelheim
Eligibility Criteria
Inclusion Criteria
Discharged from the hospital =10 days from date of randomization.
All subjects must sign an informed consent consistent with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial and conducting any study procedures.
Male or female subjects 40 years of age or older.
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Treatment Details
Interventions
- Placebo (Drug)
- Tiotropium Bromide (Anticholinergic)
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: 18 mcg tiotropiumActive Control1 Intervention
Patient to receive one tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
Group II: PlaceboPlacebo Group1 Intervention
Patient to receive one placebo capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
205.477.001001 Boehringer Ingelheim Investigational SiteSaint Petersburg, FL
205.477.001038 Boehringer Ingelheim Investigational SiteMuncie, IN
205.477.001064 Boehringer Ingelheim Investigational SiteBelleville, IL
205.477.001018 Boehringer Ingelheim Investigational SiteLivonia, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor
Trials
2566
Patients Recruited
16,150,000+