NCT07016412

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD

A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Verona Pharma plc · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).

Detailed description

Enrolled participants will be expected to participate for approximately 7 weeks: 1 to 2 weeks for screening, 4 weeks of treatment, and 1 week of follow up. Participants will be randomized to one of 6 treatment arms: two fixed dose combinations of ensifentrine (3 mg) and glycopyrrolate (either 21.25 or 42.5 mcg), the 3 individual components as monotherapies, or placebo. All treatments will be administered twice a day via oral inhalation by a standard jet nebulizer. The primary objective of this study is to evaluate the bronchodilator effects of the fixed dose combinations compared to each of the individual components and to placebo.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Ensifentrine 3 mg	Administered by a standard jet nebulizer, twice daily for 28 consecutive days
DRUG	Glycopyrrolate 21.25 mcg	Administered by a standard jet nebulizer, twice daily for 28 consecutive days
DRUG	Glycopyrrolate 42.5 mcg	Administered by a standard jet nebulizer, twice daily for 28 consecutive days
DRUG	Placebo	Administered by a standard jet nebulizer, twice daily for 28 consecutive days

Timeline

• Start date: 2025-07-31
• Primary completion: 2026-07-29
• Completion: 2026-07-29
• First posted: 2025-06-11
• Last updated: 2026-04-09

Locations

55 sites across 1 country: United States

Regulatory

• FDA-regulated drug study