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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

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 lbs (30kg) or \>330 lbs (150 kg); 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.
* Participants who have been on a stable GLP-1 agonist dose for less than 6 months prior to randomization.

Where it's running

• University of Arizona- Tuscon
  Tucson, Arizona, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Nirupama Putcha — Johns Hopkins School of Medicine
• Study coordinator: Kayla Long
• Email: klong33@jhu.edu
• Phone: 410-502-9048

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.