Tiotropium Handihaler vs. Tiotropium Respimat in COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05838703
• Other study ID #: Pro00112737
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: June 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler	Perform Pre- and Post-Spirometry with Spiriva HandiHaler to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva HandiHaler	1 visit, up to 4 hours
Primary	Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking patient while taking Spiriva Respimat	Perform Pre- and Post-Spirometry with Spiriva Respimat to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva Respimat	1 visit, up to 4 hours
Primary	Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler	Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC	1 visit, up to 4 hours
Primary	Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler	Perform Pre- and Post-Spirometry to examine the changes in FEV1	1 visit, up to 4 hours
Primary	Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler	Perform Pre- and Post-Spirometry to examine the changes in FVC	1 visit, up to 4 hours
Primary	Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler	Perform Pre- and Post-Spirometry to examine the changes in FEF25-75	1 visit, up to 4 hours
Primary	Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat	Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC	1 visit, up to 4 hours
Primary	Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat	Perform Pre- and Post-Spirometry to examine the changes in FEV1	1 visit, up to 4 hours
Primary	Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat	Perform Pre- and Post-Spirometry to examine the changes in FVC	1 visit, up to 4 hours
Primary	Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat	Perform Pre- and Post-Spirometry to examine the changes in FEF25-75	1 visit, up to 4 hours