Could an allergy drug tame COPD Flare-Ups?
NCT ID NCT07059091
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study tests if omalizumab (Xolair), an allergy drug, can reduce serious flare-ups in people with COPD who also have allergies. About 334 participants will receive injections of the drug or a placebo for 12 months. The goal is to see if the drug lowers the number of COPD exacerbations that require steroids or hospital visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- omalizumab (Xolair)
- What this could lead to
- If it works, this could provide a new treatment option to reduce COPD exacerbations in people who also have allergies.
- What could go wrong
- This is a Phase 2 trial, so it is still early. The drug may not reduce flare-ups as hoped, and side effects from injections are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 334 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
21 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor College of Medicine
RECRUITINGHouston, Texas, 77030, United States
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Columbia University
RECRUITINGNew York, New York, 10032, United States
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Cornell University
NOT_YET_RECRUITINGNew York, New York, 10032, United States
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Duke University Medical Center
ACTIVE_NOT_RECRUITINGDurham, North Carolina, 27705, United States
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Henry Ford Health
NOT_YET_RECRUITINGDetroit, Michigan, 48202, United States
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Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21231, United States
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Mount Sinai, Icahn School of Medicine
NOT_YET_RECRUITINGNew York, New York, 10029, United States
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National Jewish Health
NOT_YET_RECRUITINGDenver, Colorado, 80206, United States
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
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Pacific Northwest Airways - VA Puget Sound Healthcare System, Seattle
NOT_YET_RECRUITINGSeattle, Washington, 98108, United States
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Rush University Medical Center
NOT_YET_RECRUITINGChicago, Illinois, 60612, United States
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Temple University
RECRUITINGPhiladelphia, Pennsylvania, 19140, United States
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University of Alabama
NOT_YET_RECRUITINGBirmingham, Alabama, 35294, United States
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University of Arizona- Tuscon
RECRUITINGTucson, Arizona, 85724, United States
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University of Florida
NOT_YET_RECRUITINGJacksonville, Florida, 32209, United States
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University of Illinois at Chicago
ACTIVE_NOT_RECRUITINGChicago, Illinois, 60608, United States
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University of Iowa
NOT_YET_RECRUITINGIowa City, Iowa, 52242, United States
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University of Kansas Medical Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Pittsburgh
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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University of San Francisco
NOT_YET_RECRUITINGSan Francisco, California, 94143, United States
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University of Vermont
RECRUITINGColchester, Vermont, 05446, United States
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Vanderbilt University Medical Center
NOT_YET_RECRUITINGNashville, Tennessee, 37203, United States
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