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A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis

NCT06559150 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2026-05-13

No results posted yet for this study

Summary

This study is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of ensifentrine inhalation suspension (3 mg) delivered twice daily via standard jet nebulizer over at least 24 weeks, compared to placebo, in subjects with non-cystic fibrosis bronchiectasis (NCFBE).

Conditions

  • Non-cystic Fibrosis Bronchiectasis

Interventions

DRUG

Nebulized Ensifentrine Suspension; 3 mg

Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 52 weeks

DRUG

Nebulized Placebo Solution

Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 52 weeks

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2027-09-24
Completion
2027-09-24
FDA Drug
Yes

Countries

  • United States
  • Italy
  • Spain
  • United Kingdom

Study Locations

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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 NCT06559150 on ClinicalTrials.gov