NCT03081156

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

An Investigator Initiated, Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of Glycopyrrolate/Formoterol on Exercise Tolerance and Dynamic Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: William Stringer, md · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to determine if a dual inhaled bronchodilator (Glycopyrrolate/Formoterol) is effective in increasing exercise time relative to placebo in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description

Enrolled patients with COPD will be randomized to receive either a dual bronchodilator (Glycopyrrolate/Formoterol) or placebo inhaler, and then crossed over to receive the opposite intervention. The study will consist of two treatment periods of two weeks, seperated by a washout period of two weeks.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Glycopyrrolate / Formoterol Inhaler vs Placebo Inhaler	Exercise Tolerance

Timeline

• Start date: 2017-03-27
• Primary completion: 2019-01-01
• Completion: 2019-01-31
• First posted: 2017-03-16
• Last updated: 2025-10-21
• Results posted: 2025-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study