At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 213 enrolled
Drug / intervention
Tiotropium + olodaterol +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.
A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Compare the Efficacy of Inhaled Tiotropium + Olodaterol, Fixed Dose Combination (5 mcg/5mcg) vs. Placebo Delivered by Respimat Inhaler in Patients With Moderate to Severe COPD, Stratified by Peak Inspiratory Flow Rate [TRONARTO].
In Brief
A Phase 4 clinical trial evaluating Tiotropium + olodaterol and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 213 participants across 26 sites in 2 countries.
Detailed Summary
To demonstrate the efficacy of inhaled tiotropium + olodaterol via Respimat® on lung function in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with optimal and sub-optimal Peak Inspiratory Flow Rate (PIFR). Disease severity (moderate to severe) is based on the Global Initiative for Chronic Lung Disease (GOLD) guidelines (GOLD 2 - 3)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesGermany, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
Enrollment StartJan 2020
First PostedJan 2020
Primary CompletionSep 2020
Study CompletionSep 2020
TodayJul 2026
First PostedJan 10, 2020
Enrollment StartJan 8, 2020
Primary CompletionSep 7, 2020
Study CompletionSep 29, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.5 years ago
Interventions
Tiotropium + olodateroldrug
Oral Inhalation
Placebodrug
Oral Inhalation