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.
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|ClinicalTrials.gov Identifier: NCT04155047|
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : May 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Combination Product: Glyocopyrrolate Inhalation Solution administered by Magnair Drug: Placebo administered by Magnair||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||A Randomized, Double-blind, Placebo-controlled, 2-Way Crossover Study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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)|
|Actual Study Start Date :||November 7, 2019|
|Actual Primary Completion Date :||March 31, 2020|
|Actual Study Completion Date :||March 31, 2020|
Active Comparator: Glycopyrrolate Inhalation Solution
Glycopyrrolate Inhalation Solution 25mcg administered by Magnair
Combination Product: Glyocopyrrolate Inhalation Solution administered by Magnair
glycopyrrolate Inhalation Solution 25mcg, single dose
Other Name: LONHALA
Placebo Comparator: Placebo
Placebo Inhalation Solution administered by Magair
Drug: Placebo administered by Magnair
Placebo Inhalation Solution
- Change from baseline in Residual Volume (RV) at 6 hours postdose [ Time Frame: 6 hours post dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155047
|United States, Missouri|
|Midwest Chest Consultants|
|Saint Charles, Missouri, United States, 63301|
|Study Chair:||Respiratory Medical Director||Sunovion|