NCT04155047

A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease.

A Randomized, Double-blind, Placebo-controlled, 2-Way Crossover Study of the Effect of a Single Dose of Glycopyrrolate Inhalation Solution (GIS) on Lung Hyperinflation in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Sunovion Respiratory Development Inc. · Industry
• Sex: All
• Age: 40 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A clinical study to investigate if a single dose of an approved drug product (glycopyrrolate Inhalation Solution) reduces trapped air in the lungs of participants with chronic obstructive pulmonary disease. This study is accepting male and female participants over the age of 40. The study will be conducted at one site located in the United States.

Detailed description

This is a single center, randomized, double-blind, placebo-controlled, single-dose, 2-way crossover study in approximately 20 adult subjects ≥ 40 years of age with COPD. The study is designed to evaluate the effect of a single dose of GIS on lung hyperinflation. The two study treatments, both administered using the Magnair device. The study will randomize 10 subjects per treatment sequence, for a total of 20 subjects. At the Sponsor's discretion, additional subjects may be enrolled in an effort to achieve at least 20 completers, with no more than 24 subjects randomize. The study will consist of a Screening period, a randomized 2-way cross-over treatment period during which subjects will receive two single-doses each separated by a 7-day washout period, and a follow-up 7 (± 2) days after the last study drug dose. This study is designed to test the hypothesis that in adults with COPD subjects as characterized by the study inclusion/exclusion criteria, after 2 cross-over periods of treatment, the primary null hypothesis for this study is that the mean change of RV from baseline at 6 hours postdose for a single dose of GIS is equal to the mean change of RV from baseline at 6 hours postdose for a single dose of placebo inhalation solution (PIS). The alternative hypothesis is that these means are different.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Glyocopyrrolate Inhalation Solution administered by Magnair	glycopyrrolate Inhalation Solution 25mcg, single dose
DRUG	Placebo administered by Magnair	Placebo Inhalation Solution

Timeline

• Start date: 2019-11-07
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2019-11-07
• Last updated: 2021-05-10
• Results posted: 2021-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study