Overview

Tiotropium Handihaler vs. Tiotropium Respimat in COPD

Status:
Not yet recruiting

Trial end date:
2024-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Duke University

Treatments:

Bromides
Tiotropium Bromide

Criteria

Inclusion Criteria:

1. Outpatients of either gender, age > 40.

2. Willing and able to give informed consent and adhere to visit/protocol schedules.
(Consent must be given before any study procedures are performed)

3. Women of childbearing potential must have a negative urine pregnancy test. This will
be confirmed before participation in this investigational protocol.

4. Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating
FEV1/FVC < 0.70 in all GOLD stages (http://www.goldcopd.org/).

5. Patients who are tiotropium naïve or whose tiotropium can be withheld for 2 weeks
before screening visit/visit 1

Exclusion Criteria:

6. Upper respiratory tract infection within 6 weeks (in this case, we will re-screen the
patient after 6 weeks)

7. 24/7 oxygen use

8. Previous history of pneumothorax

9. Evidence of interstitial, occupational or chronic infectious lung disease by imaging
studies

10. For women of child bearing potential, positive pregnancy test.

11. Major chronic illnesses which in the judgement of the study physician would interfere
with participation in the study

12. History of claustrophobia