NCT05838703

Tiotropium Handihaler vs. Tiotropium Respimat in COPD

Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if tiotropium Respimat will result in better ventilation distribution of the lung in COPD participants quantified by hyperpolarized XeMRI. This study is designed to simulate the real-life clinical setting where patients receive one-time instruction on the inhaler use.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	tiotropium bromide inhalation powder (Spiriva HandiHaler)	Spiriva HandiHaler is a COPD medication that is available for use.
DRUG	tiotropium bromide (Spiriva Respimat)	Spiriva Respimat is a COPD medication that is available for use.
DRUG	Hyperpolarized 129XeMRI	Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2023-05-01
• Last updated: 2023-06-15

Regulatory

• FDA-regulated drug study