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:

• Adults of any sex aged 40 years or older.
• People who have read, understood, and signed the required consent form that has been approved by an ethics committee.
• People with a body mass index (a measure of body weight relative to height) between 17.6 and 40.0, and a body weight above 50 kg (for males) or above 40 kg (for females).
• People who have smoked cigarettes for 10 years or more.
• People who have smoked at least 10 cigarettes per day on average for at least the past year, with no more than 10 days total of not smoking during that time, confirmed by a urine test showing a cotinine level of 200 ng/mL or above.
• People who have been advised by a doctor to quit smoking, have been told about the risks of smoking and available quit programs, and are not willing to stop smoking for the length of the study.
• People who are willing to be randomly assigned to one of the two study groups.
• People who have been confirmed through breathing tests to have moderate or severe COPD (a lung condition), specifically classified as GOLD stage 2 or 3, and who also have chronic bronchitis, meaning they have had a cough with mucus on most days for more than three months a year, for at least two years in a row before joining.
• People who cough at least 10 times per hour during daytime hours (7:00 am to 10:59 pm), as measured by a sensor device worn at the first study visit.

Who may not be able to join:

• People who report using inhaled cannabis daily or any nicotine products other than cigarettes in the past year.
• People who have had a moderate or severe COPD flare-up that has not fully resolved according to standard medical guidelines or the study doctor's assessment.
• People who currently have cancer or have had any cancer in the past 5 years, except for a common and easily treated type of skin cancer called basal cell carcinoma.
• People who have a sudden worsening of chronic bronchitis symptoms, or any active breathing or body-wide infection that has not fully cleared up.
• People with health conditions that the study doctor considers would put them at risk during the study or interfere with the study results — for example, severe acid reflux, heart failure, severe lung emphysema, or active hay fever symptoms (confirm with trial site).
• People who are not legally or mentally able to give their own consent — for example, those under guardianship, in certain care facilities, incarcerated, or unable to read.
• People with a history of asthma.
• Employees of the study site or any organisation involved in the study, or their immediate family members (parent, child, or spouse).
• Current or former employees of the tobacco or e-cigarette industry, or their immediate family members.
• People with a current or recent history (within the past year) of alcohol or drug misuse.
• People who test positive for HIV, hepatitis B, or hepatitis C.
• People who, in the study doctor's judgement, have any medical, psychiatric, or social issues that would make participation unsuitable or unsafe.
• People who have taken part in another clinical trial within the past three months where the treatment may have affected COPD symptoms such as cough or breathlessness.
• People who have used corticosteroid tablets or injections, or oxygen therapy, in the past two months — except as a short-term treatment for a COPD flare-up.
• People currently using, or who have recently used, a type of blood pressure medication called ACE inhibitors (within the past 4 weeks) or opioid medicines (within the past week).
• People who have been treated with biological medicines for COPD (such as Dupilumab) within the past 6 months.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• Women who could become pregnant and do not agree to use an effective method of contraception throughout the study, and who have not had a surgical procedure to prevent pregnancy (such as a hysterectomy or tubal ligation at least 6 months ago) or are not postmenopausal (defined as having had no menstrual bleeding for at least one year).

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