RecruitingRecruiting
Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
NCT07059091 · Johns Hopkins University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)
About this study
This study is for people 40 years and older with COPD who also have allergens in their home that they are allergic to, like pet dander, cockroaches or dust mites.
Eligibility criteria
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.
Study design
Enrollment target: 334 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-02-12
Estimated completion: 2031-05
Last updated: 2026-09-04
Interventions
Drug: Omalizumab (Xolair®)Drug: Sodium Chloride (NaCl) 0.9 %
Primary outcomes
- • Rate of COPD exacerbations (12 months)
Sponsor
Johns Hopkins University · other
With: National Institute of Allergy and Infectious Diseases (NIAID), Genentech, Inc., American Lung Association Asthma Clinical Research Centers, American Lung Association
Contacts & investigators
ContactKayla Long · contact · klong33@jhu.edu · 410-502-9048
ContactHeather Hazucha · contact · hhazuch1@jhu.edu · 410-502-0585
InvestigatorNirupama Putcha · principal_investigator, Johns Hopkins School of Medicine
InvestigatorElizabeth Sugar, PhD · principal_investigator, Johns Hopkins University
All locations (23)
University of AlabamaNot Yet Recruiting
Birmingham, Alabama, United States
University of Arizona- TusconRecruiting
Tucson, Arizona, United States
University of San FranciscoNot Yet Recruiting
San Francisco, California, United States
National Jewish HealthNot Yet Recruiting
Denver, Colorado, United States
University of FloridaNot Yet Recruiting
Jacksonville, Florida, United States
University of Illinois at ChicagoActive Not Recruiting
Chicago, Illinois, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Rush University Medical CenterNot Yet Recruiting
Chicago, Illinois, United States
University of IowaNot Yet Recruiting
Iowa City, Iowa, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Henry Ford HealthNot Yet Recruiting
Detroit, Michigan, United States
Mount Sinai, Icahn School of MedicineNot Yet Recruiting
New York, New York, United States
Columbia UniversityRecruiting
New York, New York, United States
Cornell UniversityNot Yet Recruiting
New York, New York, United States
Duke University Medical CenterActive Not Recruiting
Durham, North Carolina, United States
Temple UniversityRecruiting
Philadelphia, Pennsylvania, United States
University of PittsburghRecruiting
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical CenterNot Yet Recruiting
Nashville, Tennessee, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
University of VermontRecruiting
Colchester, Vermont, United States
Pacific Northwest Airways - VA Puget Sound Healthcare System, SeattleNot Yet Recruiting
Seattle, Washington, United States