NCT04223843

A Study to Test the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler in People With Chronic Obstructive Pulmonary Disease (COPD) Who Have Different Abilities to Inhale

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].

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Tiotropium + olodaterol	Oral Inhalation
DRUG	Placebo	Oral Inhalation

Timeline

• Start date: 2020-01-08
• Primary completion: 2020-09-07
• Completion: 2020-09-29
• First posted: 2020-01-10
• Last updated: 2021-11-18
• Results posted: 2021-11-18

Locations

26 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study