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, of any sex or race
• People who have been diagnosed with COPD according to established international guidelines
• People whose breathing test results show a specific pattern of airflow limitation after using a bronchodilator (a lung-opening medication), with an FEV1/FVC ratio below 0.70 (confirm with trial site)
• People whose lung function (FEV1) measures between 30% and 80% of the expected value after using a bronchodilator (confirm with trial site)
• People who experience at least moderate breathlessness, as measured by a standard scale called the mMRC dyspnea scale (score of 2 or higher)
• People whose COPD symptoms score 10 or higher on a standard questionnaire called the COPD Assessment Test (CAT)
• People who weigh between 40 kg and 90 kg
• People whose COPD has been stable, with no changes to their standard COPD treatment in the 3 months before screening
• People who currently smoke or used to smoke, with at least 10 years of smoking history or more than 10 pack-years
• Women who could become pregnant must have a negative urine pregnancy test at screening, unless they are post-menopausal (by specific medical criteria) or have had both ovaries surgically removed at least 6 weeks prior (confirm with trial site)
• People who are sexually active with a partner of the opposite sex must agree to use double-barrier contraception (or have been surgically sterilised or be post-menopausal), and must agree not to donate sperm or eggs during the study
• People who are willing to sign a written consent form to take part in the study

Who may not be able to join:

• People who have an active cancer, or a history of cancer that has not been fully in remission for at least 5 years before screening
• People diagnosed with asthma or another significant lung disease other than COPD, such as pulmonary fibrosis, tuberculosis, sarcoidosis, bronchiectasis, or lung cancer
• People who started a pulmonary rehabilitation programme (such as supervised exercise training) within 3 months before screening, if the trial investigator believes it could affect the results
• People with a documented history of uncontrolled heart failure
• People who have high blood pressure in the lungs caused by a left-side heart condition
• People who have atrial fibrillation (an irregular heartbeat) or a significant heart defect present from birth
• People who have had a moderate or severe COPD flare-up, or who needed mechanical breathing support (not including CPAP), in the 30 days before screening
• People who are currently hospitalised at the time of screening
• People who currently have an active infection, including lung infections, widespread body infections, or serious localised infections
• People whose blood test results at screening fall outside acceptable ranges, including abnormal liver enzyme levels, reduced kidney function, low white blood cell count, low platelet count, low haemoglobin (anaemia), abnormal kidney-related urine results, or significant blood or protein in the urine (confirm with trial site)
• People with known moderate-to-severe chronic kidney disease (stage 3 or higher)
• People who have received systemic steroids, immunosuppressants, chemotherapy, radiation therapy, or similar treatments within 28 days (or longer, depending on the medication) before screening
• People with a known condition called alpha-1 antitrypsin deficiency
• People who are known to be allergic to any ingredient in the study treatment, which contains normal saline and human serum albumin (HSA)
• People with a known history of a severe allergic reaction or anaphylaxis to any drug
• People who have had major surgery requiring general anaesthesia in the 30 days before screening
• People who are known to have HIV infection or a weakened immune system
• People with a known history of alcohol or drug misuse in the 5 years before screening
• People currently taking part in another clinical trial, or who have received an investigational treatment within 3 months before screening
• People who are pregnant, planning to become pregnant within 3 months after the study treatment, or currently breastfeeding
• People whose life expectancy is less than 6 months

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