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Bronchodilator

Ensifentrine for Bronchiectasis

Phase 2
Recruiting
Research Sponsored by Verona Pharma plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable of using the study nebulizer correctly
Ability to perform acceptable spirometry
Must not have
Former smokers with a history of ≥ 10 pack years at Screening
Diagnosis of primary ciliary dyskinesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6, week 12, and week 24

Summary

"This trial will test a new inhalation treatment for people with bronchiectasis to see if it is effective and safe. Participants will inhale the treatment twice a day for at least 24 weeks

Who is the study for?
This trial is for adults with non-cystic fibrosis bronchiectasis who produce sputum, have had at least one lung infection in the past year, and can use a nebulizer correctly. Women must agree to follow contraceptive guidance if of childbearing potential. Those without a history or CT scan evidence of bronchiectasis are excluded.
What is being tested?
The study tests Ensifentrine inhalation suspension (3 mg) against a placebo solution, both delivered twice daily via nebulizer over 24 weeks. It's randomized and double-blind, meaning participants and researchers don't know who gets the real treatment or placebo.
What are the potential side effects?
While specific side effects for Ensifentrine aren't provided here, common ones for inhaled medications may include coughing, throat irritation, headache, changes in voice or taste sensation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can use the study's nebulizer correctly.
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I can successfully complete a lung function test.
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I am not pregnant or breastfeeding and follow the study's birth control requirements.
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I regularly cough up phlegm.
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I have had at least one lung flare-up in the last year.
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My chest CT shows I have bronchiectasis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have smoked at least 10 pack-years.
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I have been diagnosed with primary ciliary dyskinesia.
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I am currently being treated for a lung infection.
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I have recently taken antibiotics or inhaled steroids.
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I have been diagnosed with COPD or asthma.
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My bronchiectasis is caused by specific conditions or treatments.
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I cannot stop taking my short-acting lung medication before a lung function test.
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My kidney function is severely reduced.
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I have ongoing or a history of unstable liver disease.
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I have not had significant coughing up of blood in the last 6 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6, week 12, and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6, week 12, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Mean change from Baseline in Chronic Airways Assessment Test (CAAT) score
Mean change from Baseline in Evaluating Respiratory Symptoms (E-RS) Cough and Sputum Domain score
Mean change from Baseline in Saint George's Respiratory Questionnaire (SGRQ) score
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm 1: EnsifentrineExperimental Treatment1 Intervention
Group II: Treatment Arm 2: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Verona Pharma plcLead Sponsor
15 Previous Clinical Trials
2,857 Total Patients Enrolled
~120 spots leftby Sep 2026
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