drugset / Trial / NCT02172508

Effect of Tiotropium Inhalation Capsules on Exercise Tolerance, Daily Activity and Dyspnoea in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 3 Weeks of Pulmonary Rehabilitation

NCT02172508

Phase 4 Terminated 15 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of the study is to investigate the effect of the combined therapy 18 μg tiotropium q.d. plus pulmonary rehabilitation versus placebo plus pulmonary rehabilitation on 6-minute walking distance (6MWD) after 7 weeks of treatment in patients with moderate to severe COPD. The secondary objective of the study includes assessments of the effects of the combined therapy 18 μg Tiotropium q.d. plus rehabilitation versus placebo plus rehabilitation on dyspnoea, constant work rate exercise endurance, daily activity and lung volumes. The third objective of the study is to investigate the correlation between the results of the 6-minute walking test (6MWT), the constant work rate exercise test (CWR) and daily activity.

Timeline

Start
2004-01
Primary completion
2004-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Tiotropium Other / unclassified 18 ug Inhaled