Clinical trial NCT05838703: Tiotropium Handihaler vs. Tiotropium Respimat in COPD
Official title: Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler
timeFrame: 1 visit, up to 4 hours
measure: Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking patient while taking Spiriva Respimat
timeFrame: 1 visit, up to 4 hours
measure: Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
timeFrame: 1 visit, up to 4 hours
measure: Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
timeFrame: 1 visit, up to 4 hours
measure: Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
timeFrame: 1 visit, up to 4 hours
measure: Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
timeFrame: 1 visit, up to 4 hours
measure: Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
timeFrame: 1 visit, up to 4 hours
measure: Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
timeFrame: 1 visit, up to 4 hours
measure: Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
timeFrame: 1 visit, up to 4 hours
measure: Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
timeFrame: 1 visit, up to 4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: