At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 519 enrolled
Drug / intervention
tiotropium 18 mcg +1 moredrug
Likely dose
tiotropium 18 mcgfrom 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.
A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)
In Brief
A Phase 4 clinical trial evaluating tiotropium 18 mcg and Placebo for Pulmonary Disease, Chronic Obstructive and Exercise. Completed, enrolled 519 participants across 62 sites in 11 countries.
Detailed Summary
The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive, Exercise
CountriesArgentina, Brazil, Canada, Germany, Italy, Portugal, Russia, Spain, Taiwan, Ukraine, United States
CollaboratorsPfizer
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedSep 2007
Primary CompletionJun 2010
TodayJul 2026
First PostedSep 5, 2007
Enrollment StartAug 1, 2007
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.8 years ago
Interventions
tiotropium 18 mcgdrug
Oral inhalation once daily of 18mcg tiotropium via handihaler
Placebodrug
Oral inhalation of once-daily placebo matching tiotropium via handihaler