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RecruitingPhase 2NCT07059091

Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD

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

Sponsor

Johns Hopkins University

Enrollment

334 participants

Start Date

Feb 12, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease (COPD)Allergies

Summary

This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies. Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing omalizumab (a medication currently used for allergic asthma) in people who have COPD (chronic obstructive pulmonary disease) and are also sensitized to specific allergens like dust mites or pet dander. The goal is to see whether treating the allergic component helps reduce COPD flare-ups. **You may be eligible if...** - You are over 40 years old - You have a confirmed diagnosis of COPD and are on dual or triple inhaled therapy - You have a significant smoking history (at least 10 pack-years) - You test positive for sensitivity to specific allergens (like dust mites or cats) AND have regular allergen exposure at home - You have had at least one COPD flare-up requiring medical attention in the past year **You may NOT be eligible if...** - You have a separate diagnosis of asthma as the primary lung disease - You have no allergen sensitization or exposure - You have had very recent changes in your COPD treatment - You are pregnant or breastfeeding - You have significant uncontrolled heart or other serious conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOmalizumab (Xolair®)

The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.

DRUGSodium Chloride (NaCl) 0.9 %

The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.

Locations(23)

University of Alabama

Birmingham, Alabama, United States

University of Arizona- Tuscon

Tucson, Arizona, United States

University of San Francisco

San Francisco, California, United States

National Jewish Health

Denver, Colorado, United States

University of Florida

Jacksonville, Florida, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health

Detroit, Michigan, United States

Mount Sinai, Icahn School of Medicine

New York, New York, United States

Columbia University

New York, New York, United States

Cornell University

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Temple University

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

University of Vermont

Colchester, Vermont, United States

Pacific Northwest Airways - VA Puget Sound Healthcare System, Seattle

Seattle, Washington, United States

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NCT07059091

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