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 who have freely chosen to sign a written consent form agreeing to take part
• People aged between 40 and 80 years old, of any gender
• People with a body mass index (a measure of body weight relative to height) of 18 or above
• People who have been formally diagnosed with COPD (a long-term lung condition) according to Chinese medical guidelines, with that diagnosis documented for at least 12 months before the screening visit
• People whose breathing test results meet specific thresholds — the trial site will assess this during screening and the baseline visit (confirm with trial site)
• People who have had at least one moderate or severe COPD flare-up (a period when symptoms suddenly get much worse) in the 12 months before screening
• People who have been on a stable COPD maintenance treatment — either two or three inhaled medicines together — for at least 3 months before screening
• People whose COPD symptom score (measured using a standard questionnaire called the CAT) is 10 or higher at both the screening and enrolment visits
• People with a smoking history of at least 10 pack-years (a measure combining how much and how long a person has smoked) — this includes both current and former smokers
• People of childbearing potential who agree to use effective contraception and have no plans for pregnancy or egg/sperm donation for 6 months (for women) or 3 months (for men) after the last dose; women of childbearing potential must also have a negative pregnancy test at screening and before the first dose, and must not be breastfeeding

Who may not be able to join:

• People who have taken medicines that suppress the immune system, biological medicines, or certain allergy-related medicines within the 12 weeks before enrolment (or within a drug-specific washout period, whichever is longer)
• People who have taken certain medicines known to cause skin thickening or hardening within 4 weeks before screening
• People who have taken oral or injected corticosteroids (strong anti-inflammatory medicines), certain other lung or airway medicines, bacterial extracts, cough or mucus medicines, or received blood products or immunoglobulins within 4 weeks before enrolment
• People who have taken certain medicines that strongly affect how the body processes other drugs (known as strong CYP3A inducers or inhibitors) within 14 days or a drug-specific washout period before enrolment (confirm with trial site)
• People who have received a live, weakened live, or viral vector vaccine within 4 weeks before enrolment
• People who are currently taking part in another clinical trial of an experimental treatment, or who finished one within 3 months before screening (or are still within a washout period for that treatment)
• People who have previously been treated with the specific investigational medicine in this trial (RSS0343 tablets) or a medicine that works in the same way, within 3 months before screening
• People who have had lung surgery or a procedure to reduce lung volume within the past year, or a procedure for chronic bronchitis within the past year
• People who need supplemental oxygen for 15 or more hours per day, or who require a breathing machine; or people with significant sleep apnoea requiring a CPAP or similar breathing support device
• People who have had a moderate or severe COPD flare-up in the 4 weeks before screening up until the point of enrolment
• People who have another lung or breathing-related condition alongside their COPD
• People who have had a lung infection or other infection requiring antibiotic or antiviral treatment in the 4 weeks before screening up until enrolment
• People who have an autoimmune condition involving a type of white blood cell called eosinophils at the time of screening
• People who have been diagnosed with certain thyroid or hormonal conditions, or certain skin circulation conditions (including hypothyroidism, myxedema, chronic lymphedema, acromegaly, or livedo reticularis)
• People who have been diagnosed with certain skin conditions, including psoriasis, lichen planus, reactive arthritis with skin involvement, lupus, atopic dermatitis, various forms of chronic dermatitis, chloracne, widespread warts, or related skin disorders
• People with other serious medical conditions (as determined by the trial site)
• People whose blood tests, heart tracings (ECG), or other health checks during screening or the baseline visit fall outside the ranges set by the trial protocol (confirm with trial site)
• People with a known or suspected allergy to the trial medicine or any of its ingredients
• People who have donated or lost 200 mL or more of blood in the month before enrolment, or 400 mL or more in the 3 months before the first dose; or who have received a blood transfusion within 8 weeks before the first dose; or who have difficulty with blood draws or whose health makes frequent blood sampling unsuitable
• Women who are breastfeeding, have a positive pregnancy test, or plan to become pregnant during the study
• People with a history of drug or substance misuse in the year before screening
• People whom the trial doctor considers unsuitable for any other medical or personal reason

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