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

NCT ID: NCT03324607

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2019-11-12

Brief Summary

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.

Detailed Description

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.

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

single arm

glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study XeMRI. A follow up xeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design.

Group Type: EXPERIMENTAL

hyperpolarized 129Xe gas MRI

Intervention Type: DRUG

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 Aerosphere

Intervention Type: DRUG

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

Interventions

hyperpolarized 129Xe gas MRI

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.

Intervention Type: DRUG

Bevespi Aerosphere

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

Intervention Type: DRUG

Other Intervention Names

129Xe MRI; Inhaler

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bastiaan Driehuys

OTHER

Sponsor Role: lead

Responsible Party

Bastiaan Driehuys

Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yuh Chin Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Asthma, Allergy, and Airway Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00086693

Identifier Type: -

Identifier Source: org_study_id