At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 2,488 enrolled
Drug / intervention
tiotropium inhalation +3 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.
A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy
In Brief
A Phase 4 clinical trial evaluating tiotropium inhalation, salmeterol xinafoate, and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 2,488 participants across 222 sites in 23 countries.
Detailed Summary
This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesAustralia, Belgium, Brazil, Bulgaria, China, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, New Zealand, Philippines, Poland, Russia, South Africa, Spain, Taiwan, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedSep 2009
Primary CompletionJul 2013
TodayJul 2026
First PostedSep 11, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 16.8 years ago
Interventions
tiotropium inhalationdrug
salmeterol xinafoatedrug
fluticasone propionatedrug
placebo matched for fluticasone propionatedrug