This study is a randomized, double-blind, placebo-controlled complete block cross-over study designed to assess the efficacy, safety, and pharmacokinetics of 3 dose levels of glycopyrrolate inhalation solution delivered twice daily via standard jet nebulizer over three 1-week active treatment periods and one 1-week placebo period in subjects with chronic obstructive pulmonary disease (COPD).
Participants enrolled will be expected to participate for approximately 10 weeks;1-2 weeks for screening, four 1-week treatment periods separated by 1 week of washout between each treatment, and 1 week of follow-up. Participants will be randomized to a treatment sequence, 1-4, which will determine the order that they receive the dose levels during the four treatment periods of the study. Neither participants nor study staff will know which dose a participant is receiving in any given treatment period. All participants will receive all 4 dose levels and it is expected that each participant completes all four treatment periods in their assigned sequence. The primary objective of this study is to evaluate the bronchodilator effect of twice daily inhaled glycopyrrolate solution over a dose range administered by standard jet nebulizer in subjects with COPD on Day 7, to support the selection of the glycopyrrolate doses for further clinical development in a fixed-dose combination with ensifentrine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
46
Administered by a standard jet nebulizer, twice daily for 7 consecutive days
Administered by a standard jet nebulizer, twice daily for 7 consecutive days
Administered by a standard jet nebulizer, twice daily for 7 consecutive days
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, United States
Clinical Research of West Florida Inc - Tampa
Tampa, Florida, United States
Midwest Chest Consultants PC
Saint Charles, Missouri, United States
American Health Research Inc
Charlotte, North Carolina, United States
Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours
Time frame: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h)
The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters.
Time frame: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h)
The endpoint is measured as AUC/12 hour time interval resulting in an average volume measure in liters.
Time frame: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Evening Trough FEV1
Time frame: Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Peak FEV1 Measured Over 4 Hours After First Dose
Time frame: Baseline (pre-dose) and Day 1
Change From Average Baseline FEV1 to Average FEV1 AUC0-4h Measured After First Dose
The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters.
Time frame: Baseline (pre-dose) and Day 1
Number of Treatment Emergent Adverse Events (TEAEs)
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Administered by a standard jet nebulizer, twice daily for 7 consecutive days
Velocity Clinical Research - Greenville
Greenville, South Carolina, United States
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, United States
Velocity Clinical Research - Union
Union, South Carolina, United States
Time frame: From first dose through the follow-up contact (approximately 8 weeks per participant). Overall safety data was collected for 5 months total.
Glycopyrronium Free Base AUC0-12h
Time frame: After morning dose Day 7
Glycopyrronium Free Base Maximum Plasma Drug Concentration (Cmax)
Time frame: After morning dose Day 7
Glycopyrronium Free Base Time to Maximum Plasma Drug Concentration (Tmax)
Time frame: After morning dose Day 7