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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 Obstru

2016-11-02 07:53:22 | BioPortfolio

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Chronic Obstructive Pulmonary Disease

Intervention

Glycopyrrolate Inhalation Solution 25mg, Glycopyrrolate Inhalation Solution 75mg, Glycopyrrolate Inhalation Solution 200mg, Glycopyrrolate Inhalation Solution 200mg Jet, Glycopyrrolate Inhalation Solution 500mg, Glycopyrrolate Inhalation Solution1000mg, P

Status

Completed

Source

Sunovion Respiratory Development Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-02T07:53:22-0400

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Solution that is usually 10 percent glucose but may be higher. An isotonic solution of glucose is 5 percent.

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