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Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
Sponsor: Johns Hopkins University
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.
Official title: Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
334
Start Date
2026-02-12
Completion Date
2031-05
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
Omalizumab (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.
Sodium 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