Tiotropium Handihaler vs. Tiotropium Respimat in COPD

NCT ID: NCT05838703

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-05-01

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tiotropium bromide (Spiriva Respimat)

Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat

Group Type: EXPERIMENTAL

tiotropium bromide (Spiriva Respimat)

Intervention Type: DRUG

Spiriva Respimat is a COPD medication that is available for use.

Hyperpolarized 129XeMRI

Intervention Type: DRUG

Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved

Tiotropium bromide inhalation powder (Spiriva HandiHaler)

Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler

Group Type: ACTIVE_COMPARATOR

tiotropium bromide inhalation powder (Spiriva HandiHaler)

Intervention Type: DRUG

Spiriva HandiHaler is a COPD medication that is available for use.

Hyperpolarized 129XeMRI

Intervention Type: DRUG

Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved

Interventions

tiotropium bromide inhalation powder (Spiriva HandiHaler)

Spiriva HandiHaler is a COPD medication that is available for use.

Intervention Type: DRUG

tiotropium bromide (Spiriva Respimat)

Spiriva Respimat is a COPD medication that is available for use.

Intervention Type: DRUG

Hyperpolarized 129XeMRI

Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Yuh Chin T Huang, MD, MHS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Pro00112737

Identifier Type: -

Identifier Source: org_study_id