At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,991 enrolled
Drug / intervention
Tiotropium +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD
In Brief
A Phase 3 clinical trial evaluating Respimat and Tiotropium for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 3,991 participants across 334 sites in 31 countries.
Detailed Summary
The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesAustralia, Brazil, Canada, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Lithuania, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
First PostedOct 2006
Primary CompletionJan 2009
TodayJul 2026
First PostedOct 12, 2006
Enrollment StartSep 1, 2006
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.7 years ago
Interventions
Respimatdevice
Tiotropiumdrug