Phase 2 COPD 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:

• People who have given written agreement to take part in the study
• People with a body mass index (BMI) between 18.5 and under 35, and who weigh at least 50 kg (males) or at least 45 kg (females)
• People who have been diagnosed with COPD (a long-term lung condition) for at least 1 year
• People whose doctor has confirmed they have chronic bronchitis, meaning a persistent, mucus-producing cough lasting at least 3 months in the past year
• People who have had at least 2 moderate flare-ups, or more than 1 severe flare-up, of their COPD in the 12 months before screening
• People who currently smoke or used to smoke, with a history of at least 10 pack-years (roughly equivalent to smoking 20 cigarettes a day for 10 years)
• People who have been on a stable inhaler treatment plan for at least 3 months — either a dual inhaler combination (two types of medicines) or a triple inhaler combination (three types of medicines)
• People whose breathing test results at screening show a specific pattern consistent with COPD of moderate severity or above (confirm with trial site)
• People whose COPD symptom score (called the CAT score) is 10 or higher at screening
• People of childbearing potential who commit to using highly effective contraception and not donating eggs during the study and for at least 14 days after the last dose
• Male participants who commit to using a condom with any female partner who could become pregnant, and ensuring that partner also uses highly effective contraception — or who are vasectomised (at least 3 months before screening), or who commit to complete sexual abstinence — and who agree not to donate sperm during the study and for at least 14 days after the last dose

Who may not be able to join:

• People who have had a COPD flare-up within the 4 weeks before being assigned to a treatment group
• People who have another significant lung condition besides COPD, such as asthma, active lung infection, severe bronchiectasis, pulmonary fibrosis, cystic fibrosis, lung cancer, a genetic condition called alpha-1 antitrypsin deficiency, or tuberculosis
• People with a significant immune system problem, or who test positive for hepatitis B, hepatitis C, or HIV
• People who have had pneumonia requiring antibiotics or antiviral medicine within 28 days before the first study visit
• People who have had another significant infection (not pneumonia) requiring antibiotics or antiviral medicine within 14 days before the first study visit
• People with signs of active liver disease
• People whose heart electrical activity reading (ECG) at screening shows a specific measurement (QTcF) above the allowed level (confirm with trial site)
• People with a current or recent (within the past year) history of substance or alcohol misuse
• People with a history of cancer, except those who had certain skin cancers or cervical carcinoma in situ and completed curative treatment at least 12 months before the first visit, or those who had other cancers and completed curative treatment at least 5 years before the first visit
• People with abnormal results from physical exams, blood tests, urine tests, or vital signs during screening that the doctor considers a concern
• People with a known allergy to any ingredient in the study medication
• People currently being treated with biologic medicines for COPD (such as dupilumab or mepolizumab), or who have used such medicines recently (within 5 half-lives of the drug or 4 months, whichever is longer)
• People currently receiving long-term oxygen therapy for more than 12 hours per day
• People who have received immunoglobulin or blood products within 30 days before screening
• People who have received a live vaccine within 30 days before screening
• People who are currently in the active (early) phase of a pulmonary rehabilitation program that started less than 4 weeks before screening (those in a maintenance phase of rehabilitation may still be eligible)
• People with a history of, or active, non-hereditary palmoplantar keratosis (a skin condition affecting the hands and feet) (confirm with trial site)
• People with a tooth that could potentially cause pain or infection, unless it is treated and corrected before the study begins
• People with active gum (periodontal) disease who are currently being treated by a dentist for it, or who are expected to need gum-related dental procedures during the study period
• People who are scheduled to have a tooth extraction during the study period

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