NCT06559150

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

A Phase II, Randomized, Double-Blind, Placebo- Controlled Study of Ensifentrine in Subjects With Non-Cystic Fibrosis Bronchiectasis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Verona Pharma plc · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The primary objective of this study is to assess the effect of ensifentrine vs placebo in addition to standard of care on pulmonary exacerbations, symptoms and quality of life in participants with NCFBE. The study is designed as a pulmonary exacerbation event-driven study where participants will be treated for ≥ 24 weeks and until at least 120 subjects have experienced at least 1 protocol-defined pulmonary exacerbation. Participants will be randomized to receive either ensifentrine suspension or placebo via standard jet nebulizer during the treatment period and neither participants nor study staff will know which a participant is receiving.

Conditions

• Non-cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
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 156 weeks (3 years)
DRUG	Nebulized Placebo Solution	Administered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 156 weeks (3 years)

Timeline

• Start date: 2024-09-11
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-08-19
• Last updated: 2025-10-28

Locations

50 sites across 4 countries: United States, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study