NCT06545500

A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD

A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Verona Pharma plc · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Participants enrolled will be expected to participate for approximately 10 weeks;1-2 weeks for screening, four 1-week treatment periods separated by 1 week of washout between each treatment, and 1 week of follow-up. Participants will be randomized to a treatment sequence, 1-4, which will determine the order that they receive the dose levels during the four treatment periods of the study. Neither participants nor study staff will know which dose a participant is receiving in any given treatment period. All participants will receive all 4 dose levels and it is expected that each participant completes all four treatment periods in their assigned sequence. The primary objective of this study is to evaluate the bronchodilator effect of twice daily inhaled glycopyrrolate solution over a dose range administered by standard jet nebulizer in subjects with COPD on Day 7, to support the selection of the glycopyrrolate doses for further clinical development in a fixed-dose combination with ensifentrine.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Glycopyrrolate (85 μg)	Administered by a standard jet nebulizer, twice daily for 7 consecutive days
DRUG	Glycopyrrolate (42.5 μg)	Administered by a standard jet nebulizer, twice daily for 7 consecutive days
DRUG	Glycopyrrolate (14 μg)	Administered by a standard jet nebulizer, twice daily for 7 consecutive days
DRUG	Placebo	Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Timeline

• Start date: 2024-08-16
• Primary completion: 2025-01-02
• Completion: 2025-01-08
• First posted: 2024-08-09
• Last updated: 2026-02-09
• Results posted: 2026-02-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study