At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Single-dose, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilatory Effects of Glycopyrrolate Inhalation Solution (GIS) Using a High Efficiency Nebulizer in Patients With COPD
In Brief
A Phase 2 clinical trial evaluating Glycopyrrolate Inhalation Solution 25mg, Glycopyrrolate Inhalation Solution 75mg, and 5 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 12 participants.
Detailed Summary
The study assessed the safety and ability of several doses of an orally inhaled medicine \[ie, Glycopyrrolate Inhalation Solution = GIS\] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.
Study Details
Timeline
Interventions
25 μg oral inhalation via eFlow Nebulizer, once daily
75 μg oral inhalation via eFlow Nebulizer, once daily
200 μg oral inhalation via eFlow Nebulizer, once daily
200 μg oral inhalation via inhalation via jet nebulizer, once daily
500 μg oral inhalation via eFlow nebulizer, once daily
1000 μg oral inhalation via eFlow nebulizer, once daily
Placebo 0.5 mL oral inhalation via jet nebulizer, once daily