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

Bastiaan Driehuys

Status and phase: Completed; Phase 3; Phase 2

Conditions: COPD

Treatments: Drug: hyperpolarized 129Xe gas MRI; Drug: Bevespi Aerosphere

Study type: Interventional

Funder types: Other

Identifiers

NCT03324607

Pro00086693

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

single arm

Experimental group

Description:

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.

Treatment:

Drug: Bevespi Aerosphere

Drug: hyperpolarized 129Xe gas MRI