NCT07059091 · Johns Hopkins University
Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
(COPD-OMA)
What this study is about
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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Able and willing to provide informed consent.
- Age \>40 years at screening.
- 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 defined with positive skin prick test (SPT) (SPT wheal size
Where
- Birmingham, Alabama
- Tucson, Arizona
- San Francisco, California
- Denver, Colorado
- Jacksonville, Florida
- Chicago, Illinois
- Iowa City, Iowa
- Kansas City, Kansas
- Baltimore, Maryland
- Ann Arbor, Michigan
- Detroit, Michigan
- New York, New York
And 7 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations