Tiotropium Handihaler vs. Tiotropium Respimat in COPD

• Sponsor: Duke University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05838703
• Collaborator: (none)
• Enrollment: 25
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: tiotropium bromide inhalation powder (Spiriva HandiHaler); Drug: tiotropium bromide (Spiriva Respimat); Drug: Hyperpolarized 129XeMRI	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tiotropium bromide (Spiriva Respimat) Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat	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
Active Comparator: Tiotropium bromide inhalation powder (Spiriva HandiHaler) Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler	Drug: tiotropium bromide inhalation powder (Spiriva HandiHaler); Spiriva HandiHaler 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

Outcome Measures

Primary Outcome Measures

1. Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler [1 visit, up to 4 hours]

   Perform Pre- and Post-Spirometry with Spiriva HandiHaler to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva HandiHaler

2. Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking patient while taking Spiriva Respimat [1 visit, up to 4 hours]

   Perform Pre- and Post-Spirometry with Spiriva Respimat to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva Respimat

3. Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler [1 visit, up to 4 hours]

   Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC

4. Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler [1 visit, up to 4 hours]

   Perform Pre- and Post-Spirometry to examine the changes in FEV1

5. Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler [1 visit, up to 4 hours]

   Perform Pre- and Post-Spirometry to examine the changes in FVC

6. Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler [1 visit, up to 4 hours]

   Perform Pre- and Post-Spirometry to examine the changes in FEF25-75

7. Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat [1 visit, up to 4 hours]

   Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC

8. Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat [1 visit, up to 4 hours]

   Perform Pre- and Post-Spirometry to examine the changes in FEV1

9. Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat [1 visit, up to 4 hours]

   Perform Pre- and Post-Spirometry to examine the changes in FVC

10. Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat [1 visit, up to 4 hours]

    Perform Pre- and Post-Spirometry to examine the changes in FEF25-75

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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

2. 24/7 oxygen use

3. Previous history of pneumothorax

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

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

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

7. History of claustrophobia

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuh Chin T Huang, MD, MHS, Principal Investigator, Duke University
• ClinicalTrials.gov Identifier: NCT05838703
• Other Study ID Numbers: Pro00112737
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bromides; Tiotropium Bromide

Study Results

No Results Posted as of May 1, 2023