Phase 4 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 currently smoke or used to smoke, with a history of at least 10 pack-years of tobacco use (this means, for example, smoking one pack per day for 10 years, or two packs per day for 5 years).
• People who have been diagnosed with COPD, confirmed by a specific breathing test result (called FEV1/FVC below 0.7) taken after using a bronchodilator (a medication that opens the airways).
• People whose breathing test (FEV1, measured before using a bronchodilator) shows a result below 80% of what is considered normal, measured at the first study visit.
• People whose blood test at the first study visit shows a type of immune cell called eosinophils at fewer than 300 cells per cubic millimetre, with no recorded result above that level in the past 12 months.
• People whose breathlessness score (measured using a scale called the mMRC) is rated at 1 or higher at the first study visit.
• People whose lung volume measurement (called functional residual capacity, or FRC) is greater than 135% of the expected normal value, measured at the second study visit.
• People whose breathing test result (FEV1, measured after using a bronchodilator) is between 30% and 80% of the expected normal value, measured at the second study visit.
• People who are already using one, two, or three inhaled medications to manage their COPD on an ongoing basis.
• Women who are either unable to become pregnant, or who are using a highly effective form of contraception.
• Women who could potentially become pregnant must have a negative pregnancy test at the first study visit.

Who may not be able to join:

• People who have a current diagnosis of asthma, a condition where asthma and COPD overlap, or any other ongoing lung or breathing condition apart from COPD — such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, or pulmonary hypertension.
• People who have previously been hospitalised due to a COPD flare-up, or who have had two or more COPD flare-ups that required treatment with steroid tablets or injections.
• People who have a history of heart attack or acute coronary syndrome (a sudden, serious reduction in blood flow to the heart).
• People who have a history of, or currently have, a significant irregular heart rhythm (confirmed by a heart tracing test called an ECG).
• People who have an implanted heart device, such as a pacemaker, an implantable cardioverter defibrillator, or a cardiac resynchronisation therapy device.
• People whose heart tracing (ECG) at the first study visit shows a specific measurement called the QTcF interval above 460 milliseconds for males, or above 480 milliseconds for females (confirm with trial site).
• People who have had a respiratory tract infection (such as a chest infection) within 8 weeks before the first study visit, or during the screening and run-in period.
• People who have previously had a lung lobe removed, a lung volume reduction procedure within 3 months before the first study visit or during the study, or a lung transplant.

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