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

NCT03324607 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00086693
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  2 weeks

• Red Blood Cell (RBC) Uptake

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

  2 weeks

Secondary Outcomes (9)

• Pulmonary Function Test - Forced Vital Capacity (FVC)

  2 weeks

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

  2 weeks

• Pulmonary Function Test - Total Lung Capacity (TLC)

  2 weeks

• Pulmonary Function Test - Residual Volume (RV)

  2 weeks

• Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

  2 weeks

Study Arms (1)

single arm

EXPERIMENTAL

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.

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

Interventions

hyperpolarized 129Xe gas MRI 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.

Also known as: 129Xe MRI

single arm

Bevespi Aerosphere DRUG

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

Also known as: Inhaler

single arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bastiaan Driehuys: lead

Study Sites (1)

Duke Asthma, Allergy, and Airway Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Limitations and Caveats

20 subjects completed the study. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit; thus, a total of 17 subjects (8M 9F) were included in the data analysis.

Results Point of Contact

• Title: Yuh-Chin T. Huang, MD, MHS
• Organization: Duke University Medical Center

huang002@mc.duke.edu

9196843069

Study Officials

• Yuh Chin Huang, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 27, 2017
• Study Start: April 20, 2018
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: January 19, 2021
• Results First Posted: January 19, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)