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New treatment option for Non-cystic Fibrosis Bronchiectasis
Official title A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
ClinicalTrials.gov ID: NCT06559150
What this study is testing
What is Nebulized Ensifentrine Suspension; 3 mg?
Nebulized Ensifentrine Suspension; 3 mg is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for non-cystic fibrosis bronchiectasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance from Screening and throughout the...
- 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...
- Clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by chest CT...
You likely can't join if
- 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...
- 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)...
- Evidence within 1 year prior to randomization of obstructed lung function as shown by forced expiratory volume in 1 second (FEV1)/forced vital...
See the full eligibility criteria
Who can 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...
- 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...
- 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
What rules you out
- 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...
- 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. people with a diagnosis of PCD are permitted to be enrolled, but the proportion of people 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...
- 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: people on...
- 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...
- 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...
- 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...
- Participation in any other treatment, 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Hammond, Indiana, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Wilmington, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Sacramento, California, United States; Denver, Colorado, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.