COPD OMA

Multicenter phase II placebo-controlled, masked, randomized superiority clinical trial of omalizumab vs placebo in individuals with COPD having sensitization and exposure to indoor allergens

Study phase: II

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

1. Able and willing to provide informed consent

2. Age >40 years at screening

3. Combustible tobacco cigarette exposure >10 pack-years

4. Self-report of physician diagnosis of COPD and currently on dual or triple long-acting inhaled therapy (ICS/LABA/LAMA, ICS/LABA, LABA/LAMA)

5. Sensitization to one or more of five common indoor allergens including cat, dog, mouse, cockroach, dust mite defined with positive skin prick test (SPT) (SPT wheal size at least 3 mm greater than negative control). Positive specific IgE testing within 12 months of randomization to cat, dog, mouse, cockroach, or dust mite will be accepted in lieu of skin prick test if SPT is not interpretable or SPT cannot be safely performed

6. Exposure to the same allergen to which individual is sensitized based on measurement in home settled dust (1 U/g cockroach, 1 ?g/g mouse, 2 ?g/g dust mite, (Der f 1), 8 ?g/g for cat and dog)

Primary disease category: Allergy & Immunology

Secondary disease categories: Asthma & Lung

This study is enrolling healthy volunteers.

Sponsor: National Institutes of Health and American Lung Association

Protocol number: STUDY00007305

Projected enrollment dates: July 2025 to June 2029

Official study title: CLINICAL TRIAL OF OMALIZUMAB FOR ALLERGEN SENSITIZED AND EXPOSED INDIVIDUALS WITH COPD