Phase 2 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 are able and willing to give written consent to participate.
• People who are older than 40 years of age at the time of screening.
• People who have smoked cigarettes heavily enough to have accumulated more than 10 pack-years of smoking history.
• People who have been told by a doctor that they have COPD and are currently using two or three long-acting inhaled medications to manage it.
• People whose COPD symptom score (measured by a standard questionnaire called the CAT) is above 15, or who have had at least one significant COPD flare-up in the past year that needed oral steroids, an emergency department visit, or a hospital stay.
• People of childbearing potential who have a negative pregnancy test at the time of study entry.
• People with the ability to have children (of any sex) who agree to use FDA-approved contraception for the full duration of the study.
• People whose breathing test results show airflow limitation consistent with COPD (specifically, a post-bronchodilator FEV1/FVC ratio below 0.7 and FEV1 below 80% of what is expected for their age and size).
• People who have a confirmed allergic sensitivity to at least one of five common indoor allergens — cat, dog, mouse, cockroach, or dust mite — shown by a skin prick test or, where a skin prick test is not possible, by a blood allergy test done within the past 12 months.
• People whose home environment has been tested and found to contain measurable levels of the same allergen to which they are sensitised, at or above specified threshold amounts.

Who may not be able to join:

• People who are unable or unwilling to give written consent or follow the study requirements.
• People who live in a care facility rather than their own home.
• People who are currently breastfeeding.
• People who currently have a diagnosis of asthma.
• People who have another lung disease — such as cystic fibrosis, bronchiectasis, or an occupational lung disease — that is considered their main respiratory condition and could interfere with the study.
• People whose life expectancy is reduced due to another illness that, in the investigator's opinion, could interfere with participation.
• People with serious medical conditions that, in the investigator's view, would prevent safe participation.
• People who have received a lung transplant or are currently on a waiting list for one.
• People who have had surgical or bronchoscopic lung volume reduction procedures within the 12 months before screening.
• People with a history of tuberculosis infection or who currently have an active tuberculosis infection.
• People who have been diagnosed with or treated for a parasitic infection within the 6 months before joining the study.
• People who are currently receiving allergen immunotherapy (allergy shots or similar treatment).
• People with a history of anaphylaxis (a severe, life-threatening allergic reaction) from any cause.
• People who currently have an active prescription for an epinephrine auto-injector (such as an EpiPen) for severe chronic hives.
• People who have a known sensitivity or allergic reaction to the study drug or any other biologic medication.
• People who have used another investigational (experimental) drug for COPD in the past 90 days, or in the past 6 months if that drug was a biologic.
• People who have used a biologic medication (a type of targeted therapy delivered by injection or infusion) for a respiratory disease in the past 6 months, or for any other condition in the past 3 months.
• People who take high-dose oral corticosteroids (above 10 mg of prednisone daily, or an equivalent dose of another steroid) on an ongoing basis.
• People who have taken a course of oral corticosteroids for a COPD flare-up within 4 weeks before joining the study.
• People whose weight is below 66 lbs or above 330 lbs, or whose total IgE blood level falls outside the range of 30–700 IU/mL, or for whom no appropriate dosing recommendation exists based on their weight and IgE level.
• People who have a high level of eosinophils (a type of blood cell) above 300 and have had a flare-up requiring oral steroids in the past year, but whose current inhaler regimen does not include an inhaled corticosteroid — unless there is a medical reason (such as thrush, osteoporosis, or a recent bout of pneumonia) that prevents them from using one (confirm with trial site).

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