Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).

Boehringer Ingelheim8 sites in 1 country196 target enrollmentJuly 2003

ConditionsPulmonary Disease, Chronic Obstructive

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 196
Locations: 8
Primary Endpoint: Trough FEV1 after 12 weeks of treatment
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

March 2004

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Trough FEV1 after 12 weeks of treatment

Time Frame: 12 weeks

Secondary Outcomes

Trough FVC at Visits 3 and 4(week 8 and week 12)
Vital signs(week 8 and week 12)
Trough FEV1 at Visit 3(week 8)
24-hour holter ECG monitoring(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)
Physician's Global Evaluation(week 8 and week 12)
Adverse events(12 weeks)
Physical Exam(week 12)
12-lead ECG(week 8 and week 12)
Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4(week 8 and week 12)