Effects of Bevespi on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI

Bastiaan Driehuys20 enrolled

Overview

The purpose of this study is to determine whether the new inhaler, Bevespi improves lung function. Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, that can provide useful images of the functioning of the lung will be used as a new measure to determine change in function. The investigator anticipate these images will provide more specific information about lung disease than standard lung function tests in response to treatment.

The study will characterize ventilation and gas transfer distributions in GOLD II and III COPD patients and assess the potential for these physiological parameters as a novel phenotyping method using Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas. The study will additionally quantify regional ventilation and gas transfer response to glycopyrrolate/formoterol in GOLD II and III COPD patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

COPD

Interventions

hyperpolarized 129Xe gas MRIDRUG

There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.

Bevespi AerosphereDRUG

There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating (forced expiratory volume at 1 second(FEV1)/forced vital capacity (FVC) \< 0.70 and forced expiratory volume at 1 second (FEV1) in GOLD 2 or 3 stage (30%≤ (forced expiratory volume at 1 second \[FEV1\] \< 80%) * Willing and able to give informed consent and adhere to visit/protocol schedules * Women of childbearing potential must have a negative urine pregnancy test Exclusion Criteria: * Upper respiratory tract infection within 6 weeks * Chronic systemic corticosteroid use \> 10 mg/day of prednisone * Chronic oxygen use (intermittent or continuous) * Previous lung resection surgery or decortication * Previous history of pneumothorax * Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies * History of exposure to occupational or environmental hazards that are known to cause lung diseases * 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 * Patients who are not willing to withhold COPD inhalers for the run-in period. * MRI is contraindicated based on responses to MRI screening questionnaire * Subject is pregnant or lactating * Respiratory illness of a bacterial or viral etiology within 30 days of MRI * Subject has any form of known cardiac arrhythmia * Subject does not fit into 129Xe vest coil used for MRI * Subject cannot hold his/her breath for 15 seconds * Subject deemed unlikely to be able to comply with instructions during imaging

Locations (1)

Duke Asthma, Allergy, and Airway Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Ventilation Distribution as Measured by Ventilation Defect+Low Percent

The ventilation distribution as measured by ventilation defect+low percent is to measure the area of the lung that has no air.

Time frame: Week 2

Barrier Uptake.

Diffusion of Xe gas across the lung membrane into the blood. This measures how well oxygen goes through the lung into the blood.

Time frame: 2 weeks

Red Blood Cell (RBC) Uptake

Amount of Xe gas that enters the blood stream after it diffuses across the lung membrane

Time frame: 2 weeks

Secondary Outcomes

Pulmonary Function Test - Forced Vital Capacity (FVC)

Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry.

Time frame: 2 weeks

Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1)

FEV1 is a lung airflow measure to assess the amount of air that can be blown out in one second.

Time frame: 2 weeks

Pulmonary Function Test - Total Lung Capacity (TLC)

Total Lung Capacity (TLC) is the volume in the lungs at a maximal inhalation.

Time frame: 2 weeks

Pulmonary Function Test - Residual Volume (RV)

Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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