At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,007 enrolled
Drug / intervention
Tiotropium Inhalation Solution +1 moredrug
Likely dose
Tiotropium inhalation solution 5 mg or 10 mg once daily via Respimat deviceAI-extracted
Key inclusion· 2
- ✓Stable moderate to severe COPD
- ✓Smoking history of at least 10 pack years
Key exclusion· 8
- ✕Significant diseases other than COPD
- ✕Recent history of myocardial infarction
- ✕History of malignancy
- ✕Unstable or life-threatening cardiac arrhythmia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Tiotropium Inhalation Solution and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 1,007 participants across 76 sites in 15 countries.
Detailed Summary
To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesAustralia, Austria, Canada, Finland, France, Greece, Ireland, Italy, Netherlands, New Zealand, Russia, South Africa, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2003
Primary CompletionJun 2005
First PostedSep 2005
TodayJul 2026
First PostedSep 15, 2005
Enrollment StartFeb 1, 2003
Primary CompletionJun 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.8 years ago
Interventions
Tiotropium Inhalation Solutiondrug
Placeboother