Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
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
| Condition(s) | Chronic Obstructive Pulmonary Disease (COPD), Allergies |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 40 Years |
| Sex | All |
| Lead sponsor | Johns Hopkins University |
| Locations | Birmingham, Alabama, United States; Tucson, Arizona, United States; San Francisco, California, United States; Denver, Colorado, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States (+17 more sites) |
| Start date | 2026-02-12 |
| NCT ID | NCT07059091 |
| Official listing | https://clinicaltrials.gov/study/NCT07059091 |