Tiotropium Handihaler vs. Tiotropium Respimat in COPD

Duke University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

tiotropium bromide inhalation powder (Spiriva HandiHaler)DRUG

Spiriva HandiHaler is a COPD medication that is available for use.

tiotropium bromide (Spiriva Respimat)DRUG

Spiriva Respimat is a COPD medication that is available for use.

Hyperpolarized 129XeMRIDRUG

Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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