Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tiotropium bromide inhalation powder (Spiriva HandiHaler)
Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler
干预措施: tiotropium bromide inhalation powder (Spiriva HandiHaler) (Drug)
Tiotropium bromide inhalation powder (Spiriva HandiHaler)
Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler
干预措施: Hyperpolarized 129XeMRI (Drug)
Tiotropium bromide (Spiriva Respimat)
Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat
干预措施: tiotropium bromide (Spiriva Respimat) (Drug)
Tiotropium bromide (Spiriva Respimat)
Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat
干预措施: Hyperpolarized 129XeMRI (Drug)
结局指标
主要结局
Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEF25-75
次要结局
未报告次要终点
研究者
Yuh Chin T Huang, MD, MHS
Principal Investigator
Duke University