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 aged 40 to 80 years old (any gender) at the first screening visit
• People who have been diagnosed with chronic obstructive pulmonary disease (COPD) according to 2025 GOLD diagnostic standards, with symptoms consistent with COPD for at least 1 year — this includes ongoing breathing problems such as shortness of breath, long-term cough, or mucus production, and/or a history of exposure to risk factors, confirmed by a breathing test
• People whose breathing test results at the first screening visit show specific levels of airflow limitation (confirm with trial site for exact test values)
• People whose COPD has been stable in the 4 weeks before the screening visit, with no flare-ups
• People who are able to stop certain COPD medications that are not permitted by the trial during the screening and treatment period (a rescue inhaler called salbutamol would still be allowed)
• People who currently smoke at least 10 pack-years (for example, one pack per day for 10 years), or who formerly smoked a similar amount, or who have a history of exposure to other known risk factors for COPD

Who may not be able to join:

• People who received treatment for a COPD flare-up or were hospitalised for pneumonia within the 12 weeks before screening
• People who had an upper or lower respiratory tract infection (such as a viral or bacterial illness) or any infection requiring antibiotics within the 6 weeks before screening
• People who have another diagnosed lung or breathing condition in addition to COPD, such as asthma, active tuberculosis, cystic fibrosis, pulmonary fibrosis, pulmonary hypertension, or similar conditions
• People who have a history of, or currently have, serious heart conditions — including severe heart failure, a heart attack or heart procedure within the past 6 months, certain structural heart problems, serious abnormal heart rhythms within the past 3 months, or poorly controlled blood pressure at the time of screening
• People with type 1 diabetes, or type 2 diabetes that is not well controlled (based on a fasting blood sugar test at screening)
• People currently living with cancer (with some limited exceptions, which the trial site can confirm)
• People with other serious unstable conditions affecting the kidneys, nervous system, hormones, thyroid, urinary system, eyes, immune system, mental health, digestive system, liver, or blood — where the trial doctor determines participation could pose a risk or affect the results
• People whose blood test results at the first screening visit show certain significant abnormalities, including reduced kidney filtering function or elevated liver enzyme or bilirubin levels beyond specified thresholds (confirm with trial site for exact values)
• People who are intolerant or allergic to lactose or milk protein (dairy), or who have a known allergy to the trial drug HSK39004, salbutamol, or any components of the inhaler device
• People who used certain medications that are not permitted by the trial before the breathing test at the first screening visit (confirm with trial site for the specific list)
• People who have had a lung removal surgery or lung volume reduction surgery within the 12 months before screening
• People who had major surgery requiring general anaesthesia within the 6 weeks before screening, who have not fully recovered, or who are expected to have surgery before the trial ends
• People who, in the trial doctor's assessment, need ongoing oxygen therapy
• People with clinically significant sleep apnoea that requires use of a CPAP or similar breathing support device

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