Status:
COMPLETED
Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the effect of a 9-month treatment of tiotropium (SPIRIVA®) 18 mcg once daily on Health Related Quality of Life and lung function in patients with a Chronic ...
Detailed Description
This was a multicentre, randomised, double blind, parallel group, placebo-controlled, 9 month study. It was designed to determine the effect of inhaled tiotropium treatment on quality of life in patie...
Eligibility Criteria
Inclusion
- Diagnosis of COPD and matching the following criteria:
- Baseline 20 % \< FEV1 \< 70 % of European Community of Coal and Steel (ECCS) predicted values .
- Baseline FEV1/SVC\< 70 %. Smoking history \> 10 pack-years (p.y.). A p.y. was defined as the equivalent of smoking one pack of cigarettes per day for one year.
Exclusion
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
555 Patients enrolled
Trial Details
Trial ID
NCT00274053
Start Date
April 1 2002
End Date
April 1 2004
Last Update
November 1 2013
Active Locations (27)
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1
Boehringer Ingelheim Investigational Site
Aix-les-Bains, France, 73100
2
Hôpital Privé Antony
Antony, France, 92166
3
Boehringer Ingelheim Investigational Site
Bordeaux, France, 33100
4
Boehringer Ingelheim Investigational Site
Cambo-les-Bains, France, 64250