NCT02951312

Assessment of the Safety and Ability of a Once-a-day Dose 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)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sunovion Respiratory Development Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel. The 6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2, respectively. The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their treatment periods 1, 2, and 3, respectively. During Part II of the study, the same 12 subjects from Part I were randomized to receive either 200 mg jet or placebo in a 1:1 ratio.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Glycopyrrolate Inhalation Solution 25mg	25 μg oral inhalation via eFlow Nebulizer, once daily
DRUG	Glycopyrrolate Inhalation Solution 75mg	75 μg oral inhalation via eFlow Nebulizer, once daily
DRUG	Glycopyrrolate Inhalation Solution 200mg	200 μg oral inhalation via eFlow Nebulizer, once daily
DRUG	Glycopyrrolate Inhalation Solution 200mg Jet	200 μg oral inhalation via inhalation via jet nebulizer, once daily
DRUG	Glycopyrrolate Inhalation Solution 500mg	500 μg oral inhalation via eFlow nebulizer, once daily
DRUG	Glycopyrrolate Inhalation Solution1000mg	1000 μg oral inhalation via eFlow nebulizer, once daily
DRUG	Placebo	Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2016-11-01
• Last updated: 2018-04-30
• Results posted: 2018-04-30