Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD
1 other identifier
interventional
196
1 country
12
Brief Summary
The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 17, 2005
CompletedNovember 1, 2013
October 1, 2013
8 months
October 14, 2005
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Trough FEV1 after 12 weeks of treatment
12 weeks
Secondary Outcomes (12)
Trough FEV1 at Visit 3
week 8
Trough FVC at Visits 3 and 4
week 8 and week 12
FEV1 and FVC 90 min post study drug inhalation at all visits
90 minutes post-medication
Use of rescue medication
12 weeks
Patient's Global Evaluation
week 8 and week 12
- +7 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70%
- Smoking history greater than or equal to 10 pack years
- Not history of clinical diagnosis of asthma and/or atopy
- A history of thoracotomy with pulmonary resection
- Patients requiring the use of supplemental oxygen therapy for \>12 hours per day
- Chronic use of systemic corticosteroids in an unstable daily dose
- Patients with a recent history of myocardial infarction
- A known hypersensitivity to anticholinergic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Attn: William C. Bailey, M.D.
Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
Olive View UCLA Medical Center
Sylmar, California, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States
Respiratory Diseases (111A)
Bay Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
LSU Health Sciences Center
Shreveport, Louisiana, United States
Pulmonary and Critical Care Services, PC
Albany, New York, United States
The Oregon Clinic
Portland, Oregon, United States
Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
Boehringer Ingelheim Investigational Site
Houston, Texas, United States
Related Publications (1)
Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.
PMID: 25496316DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 17, 2005
Study Start
July 1, 2003
Primary Completion
March 1, 2004
Last Updated
November 1, 2013
Record last verified: 2013-10