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Non-cystic Fibrosis BronchiectasisPhase 2NCT06559150

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

A Phase 2 study testing Nebulized Ensifentrine Suspension; 3 mg in people with Non-cystic Fibrosis Bronchiectasis, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 51 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 up to 52 weeks, compared to placebo, in participants with non-cystic fibrosis bronchiectasis (NCFBE). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non-cystic Fibrosis Bronchiectasis
What is being tested?
Nebulized Ensifentrine Suspension; 3 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
284 participants
Where
51 sitesin 4 countries
Study dates
11 Sep 2024to 24 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication
  • Females are eligible to participate if they are not pregnant, not breastfeeding, and 1 of the following conditions apply:
  • Not a woman of childbearing potential (WOCBP) OR
  • A WOCBP who agrees to follow the contraceptive guidance from Screening throughout the study and for at least 30 days after the last dose of blinded study medication
  • Clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by chest CT demonstrating bronchiectasis affecting 1 or more lobes. Confirmation may be based on prior chest CT within the prior 5 years; subjects whose past CT image records are not available will require chest CT scan during screening Notes: If a subject has no clinical history consistent with bronchiectasis, they may not be re-screened
  • Current sputum producer with a history of chronic expectoration and able to provide sputum sample spontaneously at the clinic during screening
Show all 9Show fewer
  • ≥ 1 documented pulmonary exacerbation defined by an antimicrobial prescription (i.e., antibiotic or antiviral) by a physician for the signs and symptoms of respiratory infections in the past 12 months before screening
  • Capable of using the study nebulizer correctly
  • Ability to perform acceptable spirometry in accordance with American Thoracic Society and European Respiratory Society guidelines as assessed by the Investigator

Who cannot join

  • A diagnosis of COPD or a primary diagnosis of asthma, as judged by the investigator
  • Bronchiectasis due to cystic fibrosis, primary hypogammaglobulinemia common variable immunodeficiency, severe immunodeficiency, or requirement for treatment with intravenous immunoglobulin
  • Current smoker defined as by the Centers for Disease Control and Prevention (CDC)
  • Meets both of the following
  • Former cigarette smokers with a history of cigarette smoking ≥ 10 pack years at Screening [number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening AND
  • Evidence within 1 year prior to randomization of obstructed lung function as shown by forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of < 0.70
Show all 30Show fewer
  • A diagnosis of primary ciliary dyskinesia (PCD) is not exclusionary. Subjects with a diagnosis of PCD are permitted to be enrolled, but the proportion of subjects with PCD enrolled in the study may be limited
  • Current treatment for nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
  • Presence of acute exacerbation or acute infection that required acute treatment within 28 days of randomization
  • Use of the following prohibited medications within the designated time periods:
  • Chronic, systemic immunomodulatory agents for any chronic indication (including but not limited to the following: methotrexate, systemic corticosteroids, see adalimumab, azathioprine, dupilumab, cyclosporine, hydroxychloroquine, etc.) within 90 days prior to signing the ICF
  • CFTR modulators (e.g., ivacaftor, lumacaftor, tezacaftor) within 1 week prior to signing the ICF
  • Theophylline and oral PDE4 inhibitors (e.g., roflumilast, apremilast, crisaborole) within 48 hours prior to signing the ICF
  • Ohtuvayre at any time prior to signing the ICF
  • Initiated or altered therapy within 90 days prior to randomization with:
  • oral or inhaled antibiotics as chronic treatment (including macrolides)
  • Cyclic antibiotics: defined as prescribed regular cycles of on antibiotic treatment and off antibiotic treatment (for example, but not limited to, 28 days on an antibiotic and 28 days off an antibiotic). Note: Subjects on cyclic antibiotics must be actively taking antibiotics for at least 7 days prior to randomization through the day of randomization
  • Dipeptidyl peptidase 1 (DPP1) or cathepsin C (CatC) inhibitor (e.g., brensocatib)
  • Initiated or altered therapy with ICS within 4 weeks prior to randomization
  • Unable to withhold short-acting beta-agonists or short-acting muscarinic antagonists for ≥ 4 hours prior to spirometry
  • Significant hemoptysis (≥ 300 mL or requiring blood transfusion) within 6 weeks prior to randomization
  • Currently participating in or scheduled to participate in an intensive pulmonary rehabilitation program (a maintenance rehabilitation program is allowed if their schedule and procedure will be consistent for the duration of the study)
  • Current or chronic history of unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, or known hepatic or biliary abnormalities except for Gilbert syndrome or asymptomatic gallstones Note: Chronic stable hepatitis B and C is not exclusionary if the subject otherwise meets study entry criteria
  • History of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min
  • Alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2 × ULN, alkaline phosphatase and/or bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable only in subjects with a diagnosis of Gilbert's syndrome)
  • Participation in any other interventional, clinical studies (drugs or devices) within 30 days, or 5 half-lives, whichever is longer, prior to signing the ICF
  • Intolerance of or hypersensitivity to ensifentrine or any of its excipients/components
  • Current or history of drug or alcohol abuse within the past 5 years
  • Significantly abnormal ECG finding

Trial locations and contacts

51 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway Toll Free Number contact

Reach out by phone or email ext. 1-888-577-8839

Trialsites@msd.com

51 sites in 4 countries

United States29 sites, 28 recruiting

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

    Recruiting

  • Emory University at Saint Joseph Pulmonary Clinic

    Atlanta, Georgia, 30342

    Recruiting

  • Augusta University

    Augusta, Georgia, 30912

    Recruiting

  • Kirklin Clinic of UAB Hospital

    Birmingham, Alabama, 35233

    Recruiting

  • Massachusetts General Hospital- 55 Fruit St

    Boston, Massachusetts, 02114

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

    Recruiting

  • Medical University of South Carolina (MUSC) - PPDS

    Charleston, South Carolina, 29425

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43221

    Recruiting

  • National Jewish Health Main Campus

    Denver, Colorado, 80206

    Recruiting

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee, 37067

    Recruiting

  • ASHA Clinical Research

    Hammond, Indiana, 46324

    Recruiting

  • The Respire Institute

    Houston, Texas, 77094

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Recruiting

  • University of Kansas Medical Center-Kansas City

    Kansas City, Kansas, 66160

    Recruiting

  • So Cal Institute for Respiratory Diseases, Inc.

    Los Angeles, California, 90048

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Recruiting

  • NYU Langone Health Pulmonary and Critical Care Associates, P.C. - BRANY - PPDS

    New York, New York, 10016

    Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • University of California Davis Medical Center

    Sacramento, California, 95817

    Recruiting

  • Velocity Clinical Research - Spartanburg - PPDS

    Spartanburg, South Carolina, 29303

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • UT Texas Health Science at Tyler

    Tyler, Texas, 75708

    Recruiting

  • Velocity Clinical Research - Union - PPDS

    Union, South Carolina, 29379

    Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Recruiting

  • TPMG Clinical Research

    Williamsburg, Virginia, 23188

    Recruiting

  • Accellacare of Wilmington

    Wilmington, North Carolina, 28401

    Terminated

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

    Recruiting

Other trials in United States

United Kingdom9 sites, 9 recruiting

  • Queens Hospital Belfast

    Belfast, BT9 7AB

    Recruiting

  • Birmingham Heartlands Hospital

    Birmingham, West Midlands, B9 5SS

    Recruiting

  • Royal Papworth Hospital

    Cambridge, CB2 0AY

    Recruiting

  • Ninewells Hospital - PPDS

    Dundee, DD1 9SY

    Recruiting

  • Royal Infirmary of Edinburgh - PPDS

    Edinburgh, EH16 4SA

    Recruiting

  • Queen Elizabeth University Hospital - PPDS

    Glasgow, G12 0YN

    Recruiting

  • Liverpool Heart and Chest Hospital - PPDS

    Liverpool, L14 3PE

    Recruiting

  • Royal Brompton Hospital

    London, SW3 6HP

    Recruiting

  • Freeman Hospital

    Newcastle-under-Lyme, NE7 7DN

    Recruiting

Other trials in United Kingdom

Spain8 sites, 8 recruiting

  • Hospital Universitario A Coruña

    A Coruña, 15006

    Recruiting

  • Hospital del Mar

    Barcelona, 08003

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08036

    Recruiting

  • Hospital Universitario de Bellvitge

    Barcelona, 08907

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

    Recruiting

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

    Recruiting

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223

    Recruiting

Other trials in Spain

Italy5 sites, 5 recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

    Recruiting

  • AOU Policlinico Gaspare Rodolico-San Marco Presidio Ospedaliero Gaspare Rodolico

    Catania, Sicily, 95123

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardi, 20900

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20122

    Recruiting

Other trials in Italy

About this study

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

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 up to 52 weeks, compared to placebo, in participants with non-cystic fibrosis bronchiectasis (NCFBE).

Read the 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.

Participants will be treated for up to 52 weeks (some subjects may end earlier as the sponsor may end the study after the last subject in the study completes the Week 24 visit).

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.

Being tested
Nebulized Ensifentrine Suspension; 3 mg, Nebulized Placebo Solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nebulized Ensifentrine Suspension; 3 mgDrug

    Administered by a standard jet nebulizer, twice daily up to a maximum of 52 weeks

  • Nebulized Placebo SolutionDrug

    Administered by a standard jet nebulizer, twice daily up to a maximum of 52 weeks

Study groups in NCT06559150
Study groupRoleWhat they receive
Treatment Arm 1: EnsifentrineExperimentalNot described
Receives: Drug: Nebulized Ensifentrine Suspension; 3 mg
Treatment Arm 2: PlaceboPlacebo comparatorNot described
Receives: Drug: Nebulized Placebo Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of protocol-defined pulmonary exacerbations (number of events per subject-year)

    Measured: Through study completion (up to 52 weeks)

Secondary outcomes (11)

  1. Time to the onset of the first protocol-defined pulmonary exacerbation

    Measured: Through study completion (up to 52 weeks)

  2. Change from Baseline in Evaluating Respiratory Symptoms (E-RS) Cough and Sputum Domain score

    The E-RS is a patient reported outcome that is derived from the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT)-PRO in the participants e-diary, to quantify the severity of symptoms. The score ranges from 0 to 40 with a higher score representing more severe symptoms.

    Measured: Baseline, Week 6, Week 12, and Week 24

  3. Change from Baseline in Saint George's Respiratory Questionnaire (SGRQ) total score

    SGRQ scores range from 0 to 100, with a higher score representing worse health.

    Measured: Baseline, Week 6, Week 12, and Week 24

  4. Change from Baseline in quality of life - bronchiectasis questionnaire (QOL-B) Respiratory Symptoms Domain score

    The QOL-B Respiratory Symptoms Domain score ranges from 0 to 100, with higher scores representing better functioning.

    Measured: Baseline, Week 6, Week 12, and Week 24

  5. Change from Baseline in Chronic Airways Assessment Test (CAAT) total score

    CAAT scores range from 0-40 with a higher score representing worse health.

    Measured: Baseline, Week 6, Week 12, and Week 24

  6. Change from Baseline in Percent of the predicted forced expiratory volume over 1 second (FEV1)

    Measured: Baseline, Week 12, and Week 24

  7. Change from Baseline of forced vital capacity (FVC)

    Measured: Baseline, Week 12, and Week 24

  8. Incidence of Adverse Events

    Measured: Through study completion (approximately 52 weeks)

  9. PK Sub-study only: Ensifentrine area under the curve from time 0 to 12 hours (AUC 0 -12)

    Measured: Week 12, Week 18, and Week 24

  10. PK Sub-study only: Ensifentrine maximum plasma drug concentration (Cmax)

    Measured: Week 12, Week 18, and Week 24

  11. Pharmacokinetic (PK) Sub-study only: Ensifentrine time to Cmax (tmax) post morning dose

    Measured: Week 12, Week 18, and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start11 Sep 2024
  3. Primary completion24 Sep 2027 (estimated)
  4. Study completion24 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
284 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06559150
Sponsor's protocol ID
5884-026
Other IDs
2024-514845-12, RPL554-NCFB-220
Status last verified
Oct 2026
First submitted
14 Aug 2024
Last updated
27 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nebulized Ensifentrine Suspension; 3 mg in people with Non-cystic Fibrosis Bronchiectasis, run by Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA at 51 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, United Kingdom, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway Toll Free Number (Reach out by phone or email ext. 1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of protocol-defined pulmonary exacerbations (number of events per subject-year) (time frame: Through study completion (up to 52 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06559150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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