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

Primary Purpose

COPD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
hyperpolarized 129Xe gas MRI
Bevespi Aerosphere
Sponsored by
Bastiaan Driehuys
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke Asthma, Allergy, and Airway Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.
Red Blood Cell (RBC) Uptake
Amount of Xe gas that enters the blood stream after it diffuses across the lung membrane

Secondary Outcome Measures

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.
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.
Pulmonary Function Test - Total Lung Capacity (TLC)
Total Lung Capacity (TLC) is the volume in the lungs at a maximal inhalation.
Pulmonary Function Test - Residual Volume (RV)
Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation.
Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
DLCO measures the ability of oxygen to travel from the air sacs of the lungs to the blood stream.
6-minute Walk Test (6MWT)
The 6-minute walk test (6MWT) measures the distance walked at a natural pace for 6 minutes.
St. George's Respiratory Questionnaire (SGRQ) Score
The SGRQ is used to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Rating of Perceived Dyspnea (RPD) Scale
A patient reported outcome to measure perceived exertion during physical activity. The RPD scale goes from 0 to 10, where 0 = no shortness of breath at all and 10 = maximal shortness of breath (needing to stop the exercise or activity).
COPD Assessment Test (CAT) Score
Functional measurement for COPD patients. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

Full Information

First Posted
September 29, 2017
Last Updated
December 23, 2020
Sponsor
Bastiaan Driehuys
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1. Study Identification

Unique Protocol Identification Number
NCT03324607
Brief Title
Effects of Bevespi on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI
Acronym
COPD
Official Title
Effects of Glycopyrrolate/Formoterol (Bevespi) on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
November 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bastiaan Driehuys

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
hyperpolarized 129Xe gas MRI
Other Intervention Name(s)
129Xe MRI
Intervention Description
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
Intervention Name(s)
Bevespi Aerosphere
Other Intervention Name(s)
Inhaler
Intervention Description
There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Primary Outcome Measure Information:
Title
Ventilation Distribution as Measured by Ventilation Defect+Low Percent
Description
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
Title
Barrier Uptake.
Description
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
Title
Red Blood Cell (RBC) Uptake
Description
Amount of Xe gas that enters the blood stream after it diffuses across the lung membrane
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Pulmonary Function Test - Forced Vital Capacity (FVC)
Description
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
Title
Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1)
Description
FEV1 is a lung airflow measure to assess the amount of air that can be blown out in one second.
Time Frame
2 weeks
Title
Pulmonary Function Test - Total Lung Capacity (TLC)
Description
Total Lung Capacity (TLC) is the volume in the lungs at a maximal inhalation.
Time Frame
2 weeks
Title
Pulmonary Function Test - Residual Volume (RV)
Description
Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation.
Time Frame
2 weeks
Title
Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Description
DLCO measures the ability of oxygen to travel from the air sacs of the lungs to the blood stream.
Time Frame
2 weeks
Title
6-minute Walk Test (6MWT)
Description
The 6-minute walk test (6MWT) measures the distance walked at a natural pace for 6 minutes.
Time Frame
2 weeks
Title
St. George's Respiratory Questionnaire (SGRQ) Score
Description
The SGRQ is used to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Time Frame
2 weeks
Title
Rating of Perceived Dyspnea (RPD) Scale
Description
A patient reported outcome to measure perceived exertion during physical activity. The RPD scale goes from 0 to 10, where 0 = no shortness of breath at all and 10 = maximal shortness of breath (needing to stop the exercise or activity).
Time Frame
2 weeks
Title
COPD Assessment Test (CAT) Score
Description
Functional measurement for COPD patients. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuh Chin Huang, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Asthma, Allergy, and Airway Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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