Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (NCT07059091)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (22 items).
Location: University of Alabama โ Birmingham, Alabama
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (23 Sites)
- University of Alabama โ Birmingham, Alabama
- University of Arizona- Tuscon โ Tucson, Arizona
- University of San Francisco โ San Francisco, California
- National Jewish Health โ Denver, Colorado
- University of Florida โ Jacksonville, Florida
- University of Illinois at Chicago โ Chicago, Illinois
- Northwestern University โ Chicago, Illinois
- Rush University Medical Center โ Chicago, Illinois
- University of Iowa โ Iowa City, Iowa
- University of Kansas Medical Center โ Kansas City, Kansas
- Johns Hopkins University โ Baltimore, Maryland
- University of Michigan โ Ann Arbor, Michigan
- Henry Ford Health โ Detroit, Michigan
- Mount Sinai, Icahn School of Medicine โ New York, New York
- Columbia University โ New York, New York
- Cornell University โ New York, New York
- Duke University Medical Center โ Durham, North Carolina
- Temple University โ Philadelphia, Pennsylvania
- University of Pittsburgh โ Pittsburgh, Pennsylvania
- Vanderbilt University Medical Center โ Nashville, Tennessee
- Baylor College of Medicine โ Houston, Texas
- University of Vermont โ Colchester, Vermont
- Pacific Northwest Airways - VA Puget Sound Healthcare System, Seattle โ Seattle, Washington
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.