At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single-Dose, 6-Way Crossover Study to Assess Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebuliser in Patients With COPD
In Brief
A Phase 2 clinical trial evaluating Glycopyrrolate Inhalation Solution12.5μg, Glycopyrrolate Inhalation Solution 50μg, and 4 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 42 participants.
Detailed Summary
The study assessed the safety and ability of an orally inhaled medicine \[i.e., Glycopyrrolate Inhalation Solution = GIS\] to improve airflow in the lungs when delivered using an eFlow nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient randomly received several, single doses of GIS, or placebo, separated by approximately 1 to 2 weeks. After the dose was given, lung airflow was measured over 24 hours and blood was collected to measure how much GIS was in the bloodstream. The study was conducted to find the once-a- day GIS dose that produced the highest improvement in lung airflow using the eFlow nebulizer.
Study Details
Timeline
Interventions
Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily
Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily
Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily
Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily
Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily
Placebo 0.5mL via eFlow, once daily