Tiotropium Handihaler vs. Tiotropium Respimat in COPD
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Hyperpolarized 129XeMRI
- Registration Number
- NCT05838703
- Lead Sponsor
- Duke University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Outpatients of either gender, age > 40.
- Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed)
- Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.
- Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating FEV1/FVC < 0.70 in all GOLD stages (http://www.goldcopd.org/).
- Patients who are tiotropium naïve or whose tiotropium can be withheld for 2 weeks before screening visit/visit 1
- Upper respiratory tract infection within 6 weeks (in this case, we will re-screen the patient after 6 weeks)
- 24/7 oxygen use
- Previous history of pneumothorax
- Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies
- For women of child bearing potential, positive pregnancy test.
- Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
- History of claustrophobia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tiotropium bromide (Spiriva Respimat) tiotropium bromide (Spiriva Respimat) Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat Tiotropium bromide inhalation powder (Spiriva HandiHaler) tiotropium bromide inhalation powder (Spiriva HandiHaler) Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler Tiotropium bromide inhalation powder (Spiriva HandiHaler) Hyperpolarized 129XeMRI Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler Tiotropium bromide (Spiriva Respimat) Hyperpolarized 129XeMRI Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat
- Primary Outcome Measures
Name Time Method 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
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
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
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
- Secondary Outcome Measures
Name Time Method