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 range40 Years – 80 Years

SexALL

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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).

What they're measuring

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-02

Results submitted2025-12-11

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