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.

Phase 4 Completed 44 enrolled Sunovion Respiratory Development Inc.

RandomizedCrossoverQuadruple-blindOther

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.

Timeline

Start: 2019-11-07
Primary completion: 2020-03-31
Completion: 2020-03-31

Outcome

Missed primary endpoint

paper The primary objective of the study was not met; PMID 34232493 ↗

registry p = 0.0987 NCT04155047 ↗

Publications

Siler TM, Hohenwarter C, Xiong K, Sciarappa K, Sanjar S, Sharma S. Efficacy of Nebulized Glycopyrrolate on Lung Hyperinflation in Patients with COPD. Pulm Ther. 2021 Dec;7(2):503-516. doi: 10.1007/s41030-021-00166-5. Epub 2021 Jul 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glycopyrrolate	Small molecule	25 ug	Inhaled