At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,134 enrolled
Drug / intervention
Tiotropium +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, Parallel Group Study to Assess the Efficacy and Safety of 12 Weeks of Once Daily, Orally Inhaled, Co-administration of Olodaterol 5µg (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) Compared to Once Daily, Orally Inhaled, Co-administration of Placebo (Delivered by the Respimat® Inhaler) and Tiotropium 18µg (Delivered by the HandiHaler®) in Patients With Chronic Obstructive Pulmonary Disease (COPD)[ANHELTO TM 1]
In Brief
A Phase 3 clinical trial evaluating Tiotropium, Placebo matching Olodaterol, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 1,134 participants across 90 sites.
Detailed Summary
The overall objective of this study is to assess efficacy and safety of 12 weeks, once daily, orally inhaled co-administration of olodaterol 5 µg (delivered by the Respimat® Inhaler) and tiotropium (delivered by the Handihaler® as Spiriva Handihaler®), compared to tiotropium (Spiriva Handihaler®) monotherapy on lung function in patients with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
First PostedSep 2012
Primary CompletionAug 2013
TodayJul 2026
First PostedSep 27, 2012
Enrollment StartSep 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.8 years ago
Interventions
Tiotropiumdrug
Marketed dose
Placebo matching Olodateroldrug
One dose
Olodateroldrug
One dose
Tiotropiumdrug
Marketed dose