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Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02948582 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-03-12

Study results available
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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.

Conditions

Interventions

DRUG

Glycopyrrolate Inhalation Solution12.5μg

Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily

DRUG

Glycopyrrolate Inhalation Solution 50μg

Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily

DRUG

Glycopyrrolate Inhalation Solution 100μg

Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily

DRUG

Glycopyrrolate Inhalation Solution 200μg

Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily

DRUG

Glycopyrrolate Inhalation Solution 400μg

Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily

DRUG

Placebo 0.5mL

Placebo 0.5mL via eFlow, once daily

Sponsors & Collaborators

  • Sunovion Respiratory Development Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-11-30
Completion
2010-11-30

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Entities

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 NCT02948582 on ClinicalTrials.gov