Phase 2 COPD Trial, Recruiting

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

Who might be able to join this trial:

• People aged 40 to 80 years who have smoked at least 10 pack-years (for example, one pack per day for 10 years) and have been diagnosed with COPD based on established medical guidelines.
• People whose breathing test results show a specific level of airflow limitation — measured before and after using a reliever inhaler — that falls within a moderate-to-severe range as defined by the trial.
• People who have been regularly using a bronchodilator (airway-opening) medication for COPD for at least 4 weeks before the screening visit, and who agree to use a once-daily COPD maintenance medication supplied by the study throughout the trial.
• People who are able to correctly use a jet nebuliser (a device that turns liquid medicine into a mist for breathing in), follow all study rules and procedures, perform breathing tests to an acceptable standard, and produce a sputum (mucus) sample when asked.

Who may not be able to join:

• People who have been diagnosed with another lung condition in addition to COPD, such as asthma, cystic fibrosis, or significant bronchiectasis.
• People who were hospitalised for COPD, pneumonia, or COVID-19 in the 12 weeks before screening, or who test positive for an active COVID-19 infection at screening (confirm with trial site for re-screening rules after 30 days).
• People whose blood test results show certain elevated liver markers (ALT, alkaline phosphatase, or bilirubin) above the levels defined in the trial criteria.
• People who have HIV or another condition that weakens the immune system.
• People with a history of cancer in the past 5 years, with the exception of certain treated skin cancers (basal cell or squamous cell carcinoma of the skin).
• People who have certain abnormal heart rhythm findings on an ECG (heart tracing test) at screening, including a specific measurement called the QT interval being too long, or a history of serious heart rhythm problems or long QT syndrome.
• People with a known history of difficulties or poor outcomes with sputum induction (the procedure used to collect mucus samples).
• People who have a known allergy or sensitivity to ensifentrine or other medications used in the study, such as albuterol or salmeterol.
• People for whom the study's once-daily COPD maintenance medication is not suitable based on the medication's listed warnings or contraindications.
• People currently taking medications that are not permitted under the trial's rules.
• People who have previously received Ohtuvayre or a blinded nebulised study medication as part of an ensifentrine (RPL554) trial.
• People who have used an experimental drug or device within 30 days (or 5 half-lives, whichever is longer) before screening, or who are in a follow-up phase of another clinical trial within 30 days before screening.
• People who have any other medical condition, uncontrolled illness, or other concern that the trial investigator considers makes participation unsuitable.

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