Phase 2 Cystic Fibrosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Men who agree to use contraception during the study and for at least 30 days after their last dose of study medication
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use contraception during the study and for at least 30 days after their last dose of study medication
• People who have a history of bronchiectasis symptoms (such as cough, regularly coughing up mucus, and/or repeated chest infections), confirmed by a chest CT scan showing bronchiectasis in one or more areas of the lungs — a scan from the past 5 years may be accepted
• People who regularly cough up mucus and are able to produce a mucus sample on their own at the clinic during the screening visit
• People who have had at least one chest infection in the past 12 months that required a doctor to prescribe an antibiotic or antiviral medication
• People who are able to correctly use the study nebulizer (a device that turns liquid medicine into a mist to breathe in)
• People who are able to perform a standard breathing test (spirometry) correctly

Who may not be able to join:

• People who have been diagnosed with COPD (chronic obstructive pulmonary disease) or whose main diagnosis is asthma
• People whose bronchiectasis is caused by cystic fibrosis, certain immune system disorders, or who need regular intravenous immunoglobulin treatment
• People who currently smoke (as defined by the CDC)
• People who are former smokers with a significant smoking history (10 or more "pack years") AND who also have evidence of reduced airflow on a breathing test from within the past year
• People currently being treated for a lung infection caused by nontuberculous mycobacteria, allergic bronchopulmonary aspergillosis, or tuberculosis
• People who have had a flare-up of their lung condition or an acute infection requiring treatment within 28 days before joining the study
• People who have recently taken certain medications that are not allowed, including:
  • Long-term immune-suppressing drugs (such as methotrexate, steroids, adalimumab, or similar) within the past 90 days
  • Certain cystic fibrosis medications (such as ivacaftor or lumacaftor) within the past week
  • Theophylline or certain anti-inflammatory tablets (such as roflumilast) within the past 48 hours
  • A medication called Ohtuvayre at any point before signing up
• People who have recently started or changed treatment with antibiotics (including regular or cyclic antibiotic schedules) or a type of drug called a DPP1/CatC inhibitor (e.g., brensocatib) within 90 days before joining
• People who have recently started or changed inhaled corticosteroid (ICS) therapy within 4 weeks before joining
• People who are unable to stop using certain short-acting inhaler medicines for at least 4 hours before a breathing test
• People who have coughed up a large amount of blood (300 mL or more, or enough to need a blood transfusion) within the past 6 weeks
• People currently taking part in or planning to join an intensive pulmonary rehabilitation programme
• People with significant unstable liver disease (such as cirrhosis, jaundice, or related conditions) — note that stable hepatitis B or C does not automatically exclude someone
• People who have had cancer of any kind within the past 5 years, except for certain minor skin cancers
• People with significantly reduced kidney function (confirm with trial site)
• People with significantly abnormal liver blood test results (confirm with trial site)
• People who have taken part in another clinical drug or device trial within the past 30 days (or longer, depending on the previous study medication)
• People who are allergic or sensitive to the study drug (ensifentrine) or any of its ingredients
• People with a current or recent history (within the past 5 years) of drug or alcohol misuse
• People with a significantly abnormal heart tracing (ECG) result

Important: Always verify eligibility with the trial site directly before applying.