Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients
Overview
- Phase
- Phase 2
- Intervention
- tiotropium bromide inhalation powder (Spiriva HandiHaler)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- Duke University
- Primary Endpoint
- Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Yuh Chin T Huang, MD, MHS
Principal Investigator
Duke University
Eligibility Criteria
Inclusion Criteria
- •Outpatients of either gender, age \>
- •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
Exclusion Criteria
- •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
Arms & Interventions
Tiotropium bromide inhalation powder (Spiriva HandiHaler)
Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler
Intervention: 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
Intervention: Hyperpolarized 129XeMRI
Tiotropium bromide (Spiriva Respimat)
Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat
Intervention: tiotropium bromide (Spiriva Respimat)
Tiotropium bromide (Spiriva Respimat)
Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat
Intervention: Hyperpolarized 129XeMRI
Outcomes
Primary Outcomes
Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEF25-75