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 who are willing to sign a consent form agreeing to take part in the study and allow their medical records to be shared if needed.
• People aged 40 to 85 years old at the time of signing the consent form.
• People who are sexually active or capable of having children (both men and women) must agree to use a highly effective form of birth control — from the time they are assigned to a treatment group until 30 days after the last dose (for women) or 90 days after the last dose (for men). Women cannot rely on hormonal birth control (such as the pill) as their only method.
• People who have a confirmed diagnosis of COPD, shown by breathing tests where the airways are significantly narrowed and not fully reversed by a reliever inhaler (confirm with trial site for exact test values).
• People who have had at least one documented COPD flare-up (called an exacerbation) in the year before their screening visit, where the flare-up involved worsening breathlessness, cough, or change in mucus colour for several days and required additional treatment such as increased medication, steroids, antibiotics, or a hospital or emergency room visit.
• People who score 10 or higher on a standard COPD symptom questionnaire (called the CAT score) at the screening visit.
• People who are able to follow all study requirements, including using a mobile app daily, doing nasal swabs at home, and recognising cold symptoms.
• People who have regular contact with others at least twice a week without wearing a mask (for example, shopping, dining out, or visiting family), or who live in a home with multiple generations of family.
• People who, at the time of being assigned to a treatment group, have been on a stable COPD medication routine for at least 2 months (minor changes within the same type of medication may be allowed with study sponsor approval).
• People who are medically stable with no COPD flare-ups or respiratory infections in the 2 months before being assigned to a treatment group.
• People who test positive for rhinovirus (the common cold virus) — without any other co-infection — at the time of being assigned to a treatment group, based on an approved test.
• People who have completed at least 3 symptom score entries in the study app within the 35 days before being assigned to a treatment group.

Who may not be able to join:

• People who are pregnant, breastfeeding, or expected to become pregnant during the study.
• People who are currently having a COPD flare-up, or who have had one within 2 months of the screening visit (re-screening may be possible after 2 months of recovery).
• People whose breathing problems are primarily caused by conditions other than COPD, such as asthma alone, cystic fibrosis, certain types of scarring in the lungs, or other major lung conditions (COPD with some asthma features is generally acceptable — confirm with trial site).
• People with an unstable or poorly controlled medical condition in any other area of their health, such as heart, digestive, liver, kidney, nerve, muscle, hormone, blood, or mental health conditions.
• People who have active hepatitis B. People with HIV may be considered if on stable treatment and with permission from the medical monitor. People with hepatitis C must have completed treatment and tested negative for the virus before enrolling.
• People who have significant abnormal results on blood or other laboratory tests that suggest a serious problem with the blood, liver, or kidneys, in the opinion of the investigating doctor.
• People whose heart electrical activity reading (ECG) shows an abnormality above a certain level (confirm with trial site for exact values).
• People taking certain medications that interact with specific liver enzymes (CYP3A4, CYP2C8, or CYP2C19) in a way that could either reduce or increase the levels of the study drug in the body, or cause serious complications (confirm with trial site for specific medications).
• People taking certain medications that are processed by specific proteins in the body (MATE1, OAT3, P-gp, and BCRP), where higher levels of those medications could cause serious or life-threatening reactions.
• People taking oral or systemic steroids at a dose higher than 10 mg per day (inhaled steroids are allowed).
• People who require continuous oxygen through a nasal tube at more than 2 litres per minute at rest (higher rates during exercise may be acceptable, as long as the resting rate returns to 2 litres per minute or less).
• People who have taken part in another clinical drug trial within a specific recent timeframe, or who plan to do so during this study (observational studies without treatment are generally allowed — confirm with trial site).
• People who have previously taken the study drug (referred to as VPV) in another clinical trial.
• People for whom the investigating doctor already expects they will need antibiotics or oral steroids at the point of being assigned to a treatment group.
• People who have another active infection (such as a urinary tract infection or skin infection) requiring treatment within 7 days before or at the time of being assigned to a treatment group.

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