RecruitingChronic Obstructive Pulmonary Disease (COPD)Allergies

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

Eligible age

40+ yrs

Accepts

All genders

Locations

17 states

Healthy volunteers

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About this study

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.

Sponsor: Johns Hopkins University

You may qualify if…

✓ 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%.

You may not qualify if…

✕ 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.