Status:
COMPLETED
A Randomised, Double-blind, Placebo-controlled, 12 Week Trial to Evaluate the Effect of Tiotropium Inhalation Capsules (Spiriva) on the Magnitude of Exercise, Measured Using an Accelerometer, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine if tiotropium (Spiriva, Bromuro de Tiotropio) 18 mcg once daily by oral inhalation compared to placebo increases the magnitude of daily physical activity ob...
Detailed Description
This is a 3 month, multicentre, randomised, double-blind, placebo controlled, parallel group study to compare with placebo the long-term effect of tiotropium inhalation capsules on daily physical acti...
Eligibility Criteria
Inclusion
- All patients must sign an Informed Consent Form consistent with ICH-GPC guidelines prior to participation in the trial
- Diagnosis of COPD and meets the following spirometric criteria:
- The patients must present with relatively stable\* airway obstruction
- An FEV1 \<= 65% of the predicted normal value and an FEV1 \<= 70% of the FVC, at visit 1 (screening). This must be confirmed at visit 2 (baseline).
- Male or female patients of 40 years of age or older.
- The patients must be smokers or ex-smokers with a history of having smoked at least 10 pack-years.
- The patients must be able to carry out all the tests related to the study, including the slow and forced spirometry and the 6 minute walk test, exactly as required in the protocol.
- The patients must be able to inhale the medication by means of the HandiHaler.
Exclusion
- Those patients with significant diseases other than COPD will be excluded.
- Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during the study.
- Patients with any respiratory tract infection in the past six weeks prior to the screening visit (Visit 1) or during the run-in period, prior to Visit 2 (baseline).
- Patients with a past history of asthma, allergic rhinitis or atopy, or who present a total eosinophil count \>= 600 mm3. No new eosinophil count will be undertaken in these patients.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00144326
Start Date
July 1 2003
End Date
October 1 2005
Last Update
November 1 2013
Active Locations (27)
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1
1796 Summer Street
Halifax, Nova Scotia, Canada, B3H 3A7
2
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V6
3
Respiratory/ Research Lab
Toronto, Ontario, Canada, M5T 2S8
4
Montreal Chest Institute of the Royal Victoria Hospital
Montreal, Quebec, Canada, H2X 1P4