Trial Outcomes & Findings for Effects of Bevespi on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI (NCT NCT03324607)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

20 participants

Primary outcome timeframe

Week 2

Results posted on

2021-01-19

Participant Flow

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 Six participants were either withdrawn by the PI or voluntarily withdrew prior to starting the study.

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.

Participant milestones

Participant milestones
Measure	Treatment 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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

3 subjects were excluded due to incomplete data or poor data quality

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=20 Participants 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.
Age, Continuous	64 years STANDARD_DEVIATION 5 • n=17 Participants • 3 subjects were excluded due to incomplete data or poor data quality
Sex: Female, Male Female	9 Participants n=17 Participants • 3 subjects were excluded due to incomplete data or poor data quality
Sex: Female, Male Male	8 Participants n=17 Participants • 3 subjects were excluded due to incomplete data or poor data quality
Race/Ethnicity, Customized Hispanic	0 Participants n=20 Participants
Race/Ethnicity, Customized Non-Hispanic	17 Participants n=20 Participants
Race/Ethnicity, Customized Caucasian	17 Participants n=20 Participants
Race/Ethnicity, Customized African-American	0 Participants n=20 Participants

PRIMARY outcome

Timeframe: Week 2

Population: 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.

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

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants 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.
Ventilation Distribution as Measured by Ventilation Defect+Low Percent Baseline	57.8 percentage of total ventilation Standard Deviation 8.4
Ventilation Distribution as Measured by Ventilation Defect+Low Percent Week 2	52.5 percentage of total ventilation Standard Deviation 10.6

PRIMARY outcome

Timeframe: 2 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants 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.
Barrier Uptake. increase in barrier uptake	13 Participants
Barrier Uptake. No increase in barrier uptake	4 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Treatment n=17 Participants 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.
Red Blood Cell (RBC) Uptake Decrease in red blood cell (RBC) uptake	10 Participants
Red Blood Cell (RBC) Uptake No decrease in red blood cell (RBC) uptake	7 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: 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.

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.