Trial Outcomes & Findings for The Effect of BEVESPI AEROSPHERE ® Therapy on Exercise Tolerance in COPD (NCT NCT03081156)

Last Updated: 2025-10-21

Results Overview

To determine the magnitude of exercise time improvement (seconds) with BEVESPI AEROSPHERE ® (Glycopyrrolate/Formeterol) relative to placebo during high intensity, constant work rate cycle ergometer exercise in COPD patients.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

8-12 weeks

Results posted on

2025-10-21

Participant Flow

Sixty participants were screened for eligibility.

52 of the 60 participants signed informed consent., however, only 48 were randomized. 4 participants withdrew consent in the pre-randomization period.

Participant milestones

Participant milestones
Measure	Glycopyrrolate/Formoterol Inhaler First, Then Placebo First Intervention: Bevespi Aerosphere (Glycopyrrolate/Formoterol) twice daily for 14 days, then washout for 14 days, then Second Intervention: Placebo Inhaler twice daily for 14 days.	Placebo First, Then Glycopyrrolate/Formoterol Inhaler First Intervention: Placebo Inhaler twice daily for 14 days, then washout for 14 days, then Second Intervention: .Bevespi Aerosphere (glycopyrrolate/Formoterol) twice daily for 14 days
Overall Study STARTED	25	23
Overall Study COMPLETED	25	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of BEVESPI AEROSPHERE ® Therapy on Exercise Tolerance in COPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Received Glycopyrrolate/Formoterol Inhaler Then Placebo Inhaler n=25 Participants Participants received 14 days of the the Glycopyrrolate/Formoterol Inhaler. They They then washed out for 14 days, then received a placebo Inhaler for 14 days. At the end of the first and second 14 day intervention period, the participants performed a constant work rate bicycle ergometer exercise test to determine the effect on exercise tolerance. The outcome is time in seconds compared to their baseline value.	Participants Received Placebo Inhaler Then Glycopyrrolate/Formoterol Inhaler n=23 Participants Participants received 14 days of the a placebo inhaler. They then washed out for 14 days, then received 14 days of a Glycopyrrolate/Formoterol Inhaler	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants	15 Participants n=107 Participants	29 Participants n=206 Participants
Age, Categorical >=65 years	11 Participants n=99 Participants	8 Participants n=107 Participants	19 Participants n=206 Participants
Age, Continuous	63.4 years STANDARD_DEVIATION 7.7 • n=99 Participants	62.3 years STANDARD_DEVIATION 8.1 • n=107 Participants	62.9 years STANDARD_DEVIATION 7.81 • n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	8 Participants n=107 Participants	15 Participants n=206 Participants
Sex: Female, Male Male	18 Participants n=99 Participants	15 Participants n=107 Participants	33 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	10 Participants n=99 Participants	11 Participants n=107 Participants	21 Participants n=206 Participants
Race (NIH/OMB) White	14 Participants n=99 Participants	12 Participants n=107 Participants	26 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	25 participants n=99 Participants	23 participants n=107 Participants	48 participants n=206 Participants

PRIMARY outcome

Timeframe: 8-12 weeks

Outcome measures

Outcome measures
Measure	Glycopyrrolate/Formoterol Inhaler n=48 Participants Treatment for 2 weeks with Bevespi Aerosphere (Glycopyrrolate/Formoterol) inhaler to determine the effect on exercise tolerance using a constant work rate bicycle ergometer exercise test. The outcome is time in seconds compared to their baseline value. Glycopyrrolate / Formoterol: Exercise Tolerance	Placebo n=48 Participants Treatment for 2 weeks with a placebo Bevespi Aerosphere (Glycopyrrolate/Formoterol) inhaler to determine the effect on exercise tolerance using a constant work rate bicycle ergometer exercise test. The outcome is time in seconds compared to their baseline value. Glycopyrrolate / Formoterol: Exercise Tolerance
Change in Exercise Time (Seconds) During Cycle Ergometer Exercise.	382.50 seconds Standard Deviation 184.17	328 seconds Standard Deviation 115.45

SECONDARY outcome

Timeframe: 8 to 12 weeks

To determine if the VD/VT can be reliably assessed during constant work rate exercise using transcutaneous CO2 measurement (tcpCO2) and, if so, if BEVESPI AEROSPHERE ® (Glycopyrrolate/Formeterol) results in a reduction in VD/VT relative to placebo at isotime during high intensity constant work rate exercise in COPD patients.

Outcome measures

Outcome measures
Measure	Glycopyrrolate/Formoterol Inhaler n=48 Participants Treatment for 2 weeks with Bevespi Aerosphere (Glycopyrrolate/Formoterol) inhaler to determine the effect on exercise tolerance using a constant work rate bicycle ergometer exercise test. The outcome is time in seconds compared to their baseline value. Glycopyrrolate / Formoterol: Exercise Tolerance	Placebo n=48 Participants Treatment for 2 weeks with a placebo Bevespi Aerosphere (Glycopyrrolate/Formoterol) inhaler to determine the effect on exercise tolerance using a constant work rate bicycle ergometer exercise test. The outcome is time in seconds compared to their baseline value. Glycopyrrolate / Formoterol: Exercise Tolerance
VD/VT as Determined by Transcutaneous CO2 Measurement (tcpCO2) During Constant Work Rate Cycle Ergometer Exercise.	0.28 ratio Standard Deviation .01	.028 ratio Standard Deviation .01

Adverse Events

Glycopyrrolate/Formoterol Inhaler

Serious events: 6 serious events

Other events: 0 other events

Deaths: 48 deaths

Placebo

Serious events: 3 serious events

Other events: 0 other events

Deaths: 48 deaths

Serious adverse events

Serious adverse events
Measure	Glycopyrrolate/Formoterol Inhaler n=48 participants at risk Treatment for 2 weeks with Bevespi Aerosphere (Glycopyrrolate/Formoterol) inhaler to determine the effect on exercise tolerance using a constant work rate bicycle ergometer exercise test. The outcome is time in seconds compared to their baseline value. Glycopyrrolate / Formoterol: Exercise Tolerance	Placebo n=48 participants at risk Treatment for 2 weeks with a placebo Bevespi Aerosphere (Glycopyrrolate/Formoterol) inhaler to determine the effect on exercise tolerance using a constant work rate bicycle ergometer exercise test. The outcome is time in seconds compared to their baseline value. Glycopyrrolate / Formoterol: Exercise Tolerance
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 6/48 • Number of events 6 • 8 to 12 weeks Same Definition.	6.2% 3/48 • Number of events 3 • 8 to 12 weeks Same Definition.

Other adverse events

Adverse event data not reported

Additional Information

William Stringer, MD

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Phone: 424-571-7626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place