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

• Sponsor: Bastiaan Driehuys (Other)
• Overall Status: Completed
• CT.gov ID: NCT03324607
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 18.8
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: hyperpolarized 129Xe gas MRI; Drug: Bevespi Aerosphere	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Effects of Glycopyrrolate/Formoterol (Bevespi) on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI
• Actual Study Start Date: Apr 20, 2018
• Actual Primary Completion Date: Nov 12, 2019
• Actual Study Completion Date: Nov 12, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.; Other Names: 129Xe MRI ; Drug: Bevespi Aerosphere; There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.; Other Names: Inhaler

Outcome Measures

Primary Outcome Measures

1. Ventilation Distribution as Measured by Ventilation Defect+Low Percent [Week 2]

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

2. Barrier Uptake. [2 weeks]

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

3. Red Blood Cell (RBC) Uptake [2 weeks]

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

Secondary Outcome Measures

1. Pulmonary Function Test - Forced Vital Capacity (FVC) [2 weeks]

   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.

2. Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1) [2 weeks]

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

3. Pulmonary Function Test - Total Lung Capacity (TLC) [2 weeks]

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

4. Pulmonary Function Test - Residual Volume (RV) [2 weeks]

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

5. Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [2 weeks]

   DLCO measures the ability of oxygen to travel from the air sacs of the lungs to the blood stream.

6. 6-minute Walk Test (6MWT) [2 weeks]

   The 6-minute walk test (6MWT) measures the distance walked at a natural pace for 6 minutes.

7. St. George's Respiratory Questionnaire (SGRQ) Score [2 weeks]

   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.

8. Rating of Perceived Dyspnea (RPD) Scale [2 weeks]

   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).

9. COPD Assessment Test (CAT) Score [2 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Asthma, Allergy, and Airway Center	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Bastiaan Driehuys

Investigators

• Principal Investigator: Yuh Chin Huang, MD, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 20, 2017

More Information

Publications

None provided.

• Responsible Party: Bastiaan Driehuys, Professor of Radiology, Duke University
• ClinicalTrials.gov Identifier: NCT03324607
• Other Study ID Numbers: Pro00086693
• First Posted: Oct 27, 2017
• Last Update Posted: Jan 19, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Congenital Abnormalities

Study Results

Participant Flow

Recruitment Details

Between April 2018 and October 2019, 52 outpatient pulmonary clinic patients were approached about potential participation in the study. Twenty-six participants signed a written informed consent prior to enrollment and the HIPAA-compliant study protocol was approved by the Institutional Review Board of Duke University Medical Center (Pro00086693). Six participants were either withdrawn by the PI or voluntarily withdrew prior to starting the study.

Pre-assignment Detail

All subjects who were on regular inhalation therapies for COPD underwent a wash-out period of 7-14 days, during which time they stopped all inhaled corticosteroids, long-acting beta agonist (LABA), and long-acting muscarinic receptor antagonist (LAMA). The subjects were allowed to use inhaled albuterol as needed.

Arm/Group Title	Treatment
Arm/Group Description	Twenty patients with a pulmonologist's diagnosis of either GOLD II or III COPD and no significant comorbidities were recruited. One patient was excluded from data analysis due to poor image signal-to-noise ratio, and two patients did not have both pre- and post-treatment ventilation images; thus, a total of 17 patients (8M; 9F) were included in the data analysis. The mean age was 64.3 ± 4.9.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment
Arm/Group Description	Twenty 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. Subjects were treated with Bevespi 2 puffs twice a day for 2 weeks.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (5)
Sex: Female, Male (Count of Participants)
Female	9 45%
Male	8 40%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	0 0%
Non-Hispanic	17 85%
Caucasian	17 85%
African-American	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

17 participants were included in the data analysis. 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.

Arm/Group Title	Treatment
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Baseline	57.8 (8.4)
Week 2	52.5 (10.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Paired t-test
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

17 patients with GOLD 2 or 3 COPD 17 participants were included in the data analysis. 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.

Arm/Group Title	Single Arm
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
increase in barrier uptake	13 65%
No increase in barrier uptake	4 20%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

GOLD 2 and 3 COPD 17 participants were included in the data analysis. 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.

Arm/Group Title	Single Arm
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Decrease in red blood cell (RBC) uptake	10 50%
No decrease in red blood cell (RBC) uptake	7 35%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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. 17 participants were included in the data analysis. 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.

Arm/Group Title	Treatment
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Mean (Standard Deviation) [ml]	342 (286)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Mean (Standard Deviation) [ml]	219 (168)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Mean (Standard Deviation) [ml]	183 (411)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Mean (Standard Deviation) [ml]	-108 (508)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Mean (Standard Deviation) [mL/min/mmHg]	0.2 (1.3)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Mean (Standard Deviation) [meters]	16.2 (37.6)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Mean (Standard Deviation) [score on a scale]	-1.2 (5.8)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Mean (Standard Deviation) [score on a scale]	-0.75 (2.33)

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Single Arm
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
Measure Participants	17
Mean (Standard Deviation) [score on a scale]	-3.8 (4.5)

Adverse Events

Time Frame	1 month
Arm/Group Title	Treatment
Arm/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. 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. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
All Cause Mortality
	Treatment
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Serious Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Other (Not Including Serious) Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	0/17 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.