Tiotropium Handihaler vs. Tiotropium Respimat in COPD

Study 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.

Official Title
-----------------
Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: tiotropium bromide inhalation powder (Spiriva HandiHaler)
* Drug: tiotropium bromide (Spiriva Respimat)
* Drug: Hyperpolarized 129XeMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tiotropium bromide (Spiriva Respimat)<br>Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat | Drug: tiotropium bromide (Spiriva Respimat)<br>* Spiriva Respimat is a COPD medication that is available for use.<br>Drug: Hyperpolarized 129XeMRI<br>* Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved<br>|
| Active Comparator: Tiotropium bromide inhalation powder (Spiriva HandiHaler)<br>Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler | Drug: tiotropium bromide inhalation powder (Spiriva HandiHaler)<br>* Spiriva HandiHaler is a COPD medication that is available for use.<br>Drug: Hyperpolarized 129XeMRI<br>* Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler | Perform Pre- and Post-Spirometry with Spiriva HandiHaler to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva HandiHaler | 1 visit, up to 4 hours | 
| Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking patient while taking Spiriva Respimat | Perform Pre- and Post-Spirometry with Spiriva Respimat to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva Respimat | 1 visit, up to 4 hours | 
| Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler | Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC | 1 visit, up to 4 hours | 
| Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler | Perform Pre- and Post-Spirometry to examine the changes in FEV1 | 1 visit, up to 4 hours | 
| Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler | Perform Pre- and Post-Spirometry to examine the changes in FVC | 1 visit, up to 4 hours | 
| Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler | Perform Pre- and Post-Spirometry to examine the changes in FEF25-75 | 1 visit, up to 4 hours | 
| Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat | Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC | 1 visit, up to 4 hours | 
| Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat | Perform Pre- and Post-Spirometry to examine the changes in FEV1 | 1 visit, up to 4 hours | 
| Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat | Perform Pre- and Post-Spirometry to examine the changes in FVC | 1 visit, up to 4 hours | 
| Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat | Perform Pre- and Post-Spirometry to examine the changes in FEF25-75 | 1 visit, up to 4 hours |