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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 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-06-24

No results posted yet for this study

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tiotropium Inhalation Capsule

DRUG

Placebo Lactose Capsule

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2004-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02172508 on ClinicalTrials.gov