Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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.
Interventions
DRUGtiotropium bromide inhalation powder (Spiriva HandiHaler)
Spiriva HandiHaler is a COPD medication that is available for use.
Spiriva Respimat is a COPD medication that is available for use.
Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 FEV1/FVC |
| 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 FEV1/FVC |
Outcome results
None listed