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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single-Dose, 6-Way Crossover Study to Assess Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebuliser in Patients With COPD

NCT02948582•Sunovion Respiratory Development Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 75 years

Sex

All

Healthy Volunteers

Inclusion Criteria

•1. Male and female patients aged 40 through 75 years, inclusive
•2. A clinical diagnosis of COPD according to the GOLD guidelines
•3. Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10
•4. Post-bronchodilator FEV1 30-70% of predicted normal at the Screening Visit
•5. Post-bronchodilator FEV1/FVC ratio \< 0.70 at the Screening Visit
•6. Improvement in FEV1 \>12% and 150 mL following inhalation of ipratropium bromide at the Screening Visit
•7. Ability to perform reproducible spirometry according to the ATS/ERS guidelines
•8. Willing to stay at the study site for approximately 30 hours on each treatment visit
•9. Willing and able to provide written informed consent

Exclusion Criteria

•1. Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using one of the following acceptable means of birth control throughout the study:
•* Abstinence
•* Post-menopausal for at least two years
•* Surgically sterile (i.e., tubal ligation, hysterectomy)
•* Oral contraceptives (taken for at least one month prior to the Screening Visit)
•* Approved implantable or injectable contraceptives (e.g., Norplant®, Depo-Provera® or equivalent)
•* Barrier methods (e.g., condoms with spermicide)
•* Intrauterine device (i.e., IUD)
•* Vasectomy of male partner
•* Non-heterosexual life style
+18 more criteria

Key Dates

Start Date

July 1, 2010

Primary Completion Date

November 1, 2010

Completion Date

November 1, 2010

Last Updated

March 12, 2018

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Glycopyrrolate Inhalation Solution12.5μg

DRUG

Glycopyrrolate Inhalation Solution 50μg

DRUG

Glycopyrrolate Inhalation Solution 100μg

DRUG

Glycopyrrolate Inhalation Solution 200μg

DRUG

Glycopyrrolate Inhalation Solution 400μg

DRUG

Placebo 0.5mL

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

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RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

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A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

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