Tiotropium Handihaler vs. Tiotropium Respimat in COPD

Duke University

Status and phase: Withdrawn; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: tiotropium bromide (Spiriva Respimat); Drug: Hyperpolarized 129XeMRI; Drug: tiotropium bromide inhalation powder (Spiriva HandiHaler)

Study type: Interventional

Funder types: Other

Identifiers

NCT05838703

Pro00112737

Details and patient eligibility

About

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.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Tiotropium bromide (Spiriva Respimat)

Experimental group

Description:

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

Treatment:

Drug: Hyperpolarized 129XeMRI

Drug: tiotropium bromide (Spiriva Respimat)

Tiotropium bromide inhalation powder (Spiriva HandiHaler)

Active Comparator group

Description:

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

Treatment:

Drug: tiotropium bromide inhalation powder (Spiriva HandiHaler)

Drug: Hyperpolarized 129XeMRI