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

Conditions

• Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Jul 31, 2025

Status verified

Jun 2026

Primary completion

Aug 5, 2026

Completion

Aug 5, 2026

Study Design

Enrollment

480 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Arm A: Ensifentrine plus Glycopyrrolate
  Ensifentrine 3 mg / Glycopyrrolate 42.5 mcg
• Experimental: Treatment Arm B: Ensifentrine plus Glycopyrrolate
  Ensifentrine 3 mg / Glycopyrrolate 21.25 mcg
• Active Comparator: Treatment Arm C: Glycopyrrolate
  Glycopyrrolate monotherapy 42.5 mcg
• Active Comparator: Treatment Arm D: Glycopyrrolate
  Glycopyrrolate monotherapy 21.25 mcg
• Active Comparator: Treatment Arm E: Ensifentrine
  Ensifentrine monotherapy 3 mg
• Placebo Comparator: Treatment Arm F: Placebo
  Placebo

Primary Outcome Measure

Change from baseline in average forced expiry volume in 1 second (FEV1) area under the curve versus time, from time 0 to 4 hours (AUC0-4h) [ Time Frame: Baseline and Day 28 ]

Central Contacts

• Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway Toll Free Number
  Reach out by phone or email
  [email protected]

Locations (57)

Find similar trials in Dothan, AL

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