A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD (NCT06545500) | Clinical Trial Compass
CompletedPhase 2
A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
United States46 participantsStarted 2024-08-16
Plain-language summary
This study is a randomized, double-blind, placebo-controlled complete block cross-over study designed to assess the efficacy, safety, and pharmacokinetics of 3 dose levels of glycopyrrolate inhalation solution delivered twice daily via standard jet nebulizer over three 1-week active treatment periods and one 1-week placebo period in subjects with chronic obstructive pulmonary disease (COPD).
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Not a woman of childbearing potential (WOCBP) OR
. A WOCBP who agrees to follow the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
. FEV1/forced vital capacity (FVC) ratio of \< 0.70 AND
. FEV1 ≥ 30 % and ≤ 70% of predicted normal
Exclusion criteria
. COPD exacerbation requiring hospitalization.
. Use of therapies for COPD exacerbation (e.g., oral, intravenous, or intramuscular glucocorticoids).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Timeframe: Baseline (pre-dose for each treatment period) and Day 7
Trial details
NCT IDNCT06545500
SponsorVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA