Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)
This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies. Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.
• Able and willing to provide informed consent.
• Age ≥ 40 years at screening.
• Primary combustible tobacco cigarette exposure \>10 pack-years.
• Self-report of physician diagnosis of COPD and currently on dual or triple long-acting inhaled therapy (ICS/LABA/LAMA, ICS/LABA, LABA/LAMA).
• COPD Assessment Test (CAT) score of ≥ 15 OR history of at least one documented moderate (requiring treatment with oral corticosteroids) or severe (requiring ED visit or hospitalization) COPD exacerbation in the past year.
• Participants of childbearing potential must have negative pregnancy test upon study entry.
• Female (and male) participants with reproductive potential must agree to use FDA approved methods of contraception for duration of study.
• Post-bronchodilator FEV1/FVC ratio \< 0.7 and FEV1% predicted \< 80%.
• Sensitization to one or more of five common indoor allergens including cat, dog, mouse, cockroach, dust mite confirmed with specific IgE. Positive specific IgE testing within 12 months of randomization to cat, dog, mouse, cockroach, or dust mite will be accepted
• Exposure to the same allergen to which individual is sensitized based on measurement in home settled dust (1 U/g cockroach, 1 μg/g mouse, 2 μg/g dust mite, (Der f 1), 8 μg/g for cat and dog).
• Participants on a stable dose for \>6 months will be allowed to enroll