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Omalizumab for people with COPD who are allergic to common indoor allergens

Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)

Phase 2 Interventional Johns Hopkins University · NCT07059091

This trial will test whether monthly injections of omalizumab (Xolair) help people aged 40+ with COPD who are allergic to and exposed to common indoor allergens reduce symptoms or exacerbations.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment334 (estimated)
Ages40 Years and up
SexAll
SponsorJohns Hopkins University Academic / other
Drugs / interventionsbenralizumab, omalizumab, mepolizumab, resilizumab, dupliumab, tezepelumab, immunotherapy, prednisone
Locations23 sites (Birmingham, Alabama and 22 other locations)
Trial IDNCT07059091 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial enrolls adults 40 and older with physician-diagnosed COPD who are sensitized to common indoor allergens and have ongoing exposure at home. After a screening period, participants receive study injections in clinic over a 12-month treatment phase and have a follow-up contact one month after the last visit. The interventions include omalizumab (Xolair) and a saline comparator, with clinical outcomes tracked over the treatment year. Key eligibility includes airflow obstruction on post-bronchodilator spirometry, a significant smoking history, current inhaled COPD therapy, and either a high symptom score or recent exacerbation history.

Who should consider this trial

Good fit: Ideal candidates are adults 40 or older with COPD (post-bronchodilator FEV1/FVC < 0.7 and FEV1% predicted < 80%), >10 pack-year smoking history, on dual or triple inhaled therapy, sensitized to at least one common indoor allergen with household exposure, and a CAT score >15 or a recent moderate/severe exacerbation.

Not a fit: Patients who are not allergic or not regularly exposed to indoor allergens, younger than 40, have very mild COPD, or whose disease is driven by non-allergic mechanisms are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the drug could reduce COPD symptoms and exacerbations and improve quality of life for allergic, allergen-exposed patients.

How similar studies have performed: Omalizumab is an established therapy for allergic asthma, but its use in allergen-sensitized COPD is relatively novel with only limited prior data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Able and willing to provide informed consent.
* Age \>40 years at screening.
* 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 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.
* 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).

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
* Live in a location other than home (i.e., care facility)
* Actively breastfeeding.
* Current asthma diagnosis.
* Other lung disease (cystic fibrosis, pneumoconiosis, bronchiectasis or otherwise) that is considered the primary respiratory diagnosis and would interfere with participation in the study
* Reduced life expectancy due to other disease that in the opinion of the investigator may interfere with participation in the study.
* Participants with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
* Received or listed for a lung transplant.
* Surgical or bronchoscopic lung volume reduction surgery in the 12 months prior to screening.
* History of infection or active infection due to Mycobacterium tuberculosis
* Active parasitic infection diagnosed and/or treated within 6 months of randomization
* Currently receiving allergen immunotherapy.
* History of anaphylaxis from medications, foods or otherwise.
* Current active prescription for epinephrine autoinjector for treatment of severe chronic urticaria.
* Known sensitivity to study drug(s) or another biologic medication.
* Use of any other investigational agent for COPD in the last 90 days. If the other investigational agent being used is a biologic agent, this must be washed out for 6 months prior to randomization.
* Active use of biologic medication (monoclonal antibody) for treatment of respiratory disease in the past 6 months (benralizumab, omalizumab, mepolizumab, resilizumab, dupliumab, tezepelumab, or other similar medication or use of biologic medication for treatment of any non-respiratory disease in the past 3 months.
* Use of chronic systemic corticosteroids at doses above 10mg daily prednisone or the equivalent.
* Use of systemic corticosteroid course for acute exacerbation of COPD within 4 weeks of randomization.
* Weight \< 66 or \>330 lbs; and total IgE \< 30 IU/mL or \>700 IU/mL; or no available dosing recommendation based on weight and total IgE level.
* No ICS in background regimen for individuals with blood eosinophil count of \>300 and systemic steroid requiring exacerbation in the past year, except in case of contraindication to ICS such as thrush, osteoporosis, or pneumonia in the past year.

Where this trial is running

Birmingham, Alabama and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary DiseaseAllergieslung diseaseCOPDallergies
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.