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New inhaler aims to cut dangerous lung Flare-Ups in bronchiectasis patients

NCT ID NCT06559150

Disease control Sponsor: Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests an inhaled drug called ensifentrine in 284 adults with non-cystic fibrosis bronchiectasis, a lung condition that causes frequent infections and breathing problems. Participants will receive either the drug or a placebo twice daily for at least 24 weeks. The goal is to see if ensifentrine can reduce the number of serious lung flare-ups and improve symptoms like cough and mucus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 284 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. Not a woman of childbearing potential (WOCBP) OR 2. 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 * ≥ 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 Exclusion Criteria: * 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 1. 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 2. 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 * 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: 1. 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 2. CFTR modulators (e.g., ivacaftor, lumacaftor, tezacaftor) within 1 week prior to signing the ICF 3. Theophylline and oral PDE4 inhibitors (e.g., roflumilast, apremilast, crisaborole) within 48 hours prior to signing the ICF 4. Ohtuvayre at any time prior to signing the ICF * Initiated or altered therapy within 90 days prior to randomization with: 1. oral or inhaled antibiotics as chronic treatment (including macrolides) 2. 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 3. 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

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Conditions

The condition(s) this trial relates to.

bronchiectasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-cystic fibrosis bronchiectasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    50 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    RECRUITING

    Catania, Sicily, 95123, Italy

  • ASHA Clinical Research

    RECRUITING

    Hammond, Indiana, 46324, United States

  • Accellacare of Wilmington

    TERMINATED

    Wilmington, North Carolina, 28401, United States

  • Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Birmingham Heartlands Hospital

    RECRUITING

    Birmingham, West Midlands, B9 5SS, United Kingdom

  • Clinical Trials Center of Middle Tennessee

    RECRUITING

    Franklin, Tennessee, 37067, United States

  • Emory University at Saint Joseph Pulmonary Clinic

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, Pavia, 27100, Italy

  • Fondazione IRCCS San Gerardo dei Tintori

    RECRUITING

    Monza, Lombardi, 20900, Italy

  • Freeman Hospital

    RECRUITING

    Newcastle-under-Lyme, NE7 7DN, United Kingdom

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, Madrid, 28009, Spain

  • Hospital Universitario A Coruña

    RECRUITING

    A Coruña, A Coruña, 15006, Spain

  • Hospital Universitario La Paz - PPDS

    RECRUITING

    Madrid, Madrid, 28046, Spain

  • Hospital Universitario Quironsalud Madrid

    RECRUITING

    Madrid, 28223, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Hospital Universitario de Bellvitge

    RECRUITING

    Barcelona, Barcelona, 08907, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, Barcelona, 08003, Spain

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    RECRUITING

    Bologna, Bologna, 40138, Italy

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Lombardy, 20122, Italy

  • Kirklin Clinic of UAB Hospital

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Liverpool Heart and Chest Hospital - PPDS

    RECRUITING

    Liverpool, L14 3PE, United Kingdom

  • Massachusetts General Hospital- 55 Fruit St

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Medical University of South Carolina (MUSC) - PPDS

    RECRUITING

    Charleston, South Carolina, 29425, United States

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

    RECRUITING

    New York, New York, 10016, United States

  • National Jewish Health Main Campus

    RECRUITING

    Denver, Colorado, 80206, United States

  • Ninewells Hospital - PPDS

    RECRUITING

    Dundee, Dundee, DD1 9SY, United Kingdom

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43221, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Queen Elizabeth University Hospital - PPDS

    RECRUITING

    Glasgow, Glasgow, G12 0YN, United Kingdom

  • Queens Hospital Belfast

    RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Royal Brompton Hospital

    RECRUITING

    London, SW3 6HP, United Kingdom

  • Royal Infirmary of Edinburgh - PPDS

    RECRUITING

    Edinburgh, EH16 4SA, United Kingdom

  • Royal Papworth Hospital

    RECRUITING

    Cambridge, CB2 0AY, United Kingdom

  • So Cal Institute for Respiratory Diseases, Inc.

    RECRUITING

    Los Angeles, California, 90048, United States

  • Southeastern Research Center

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • TPMG Clinical Research

    RECRUITING

    Williamsburg, Virginia, 23188, United States

  • Temple University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • The Respire Institute

    RECRUITING

    Houston, Texas, 77094, United States

  • UT Texas Health Science at Tyler

    RECRUITING

    Tyler, Texas, 75708, United States

  • University of California Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center-Kansas City

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • Velocity Clinical Research - Spartanburg - PPDS

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • Velocity Clinical Research - Union - PPDS

    RECRUITING

    Union, South Carolina, 29379, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.