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

NCT07016412 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-05-13

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-08-05
Completion
2026-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07016412 on ClinicalTrials.gov