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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 Obstructive Pulmonary Disease (COPD)

NCT02951312 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-04-30

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Sunovion Respiratory Development Inc.

    lead INDUSTRY

Principal Investigators

  • Ahmet Tutuncu, MD, PhD · Elevation Pharmaceuticals, Inc.(now known as Sunovion Respiratory Development Inc.)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-07-31
Completion
2009-07-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02951312 on ClinicalTrials.gov