Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Omalizumab (Xolair®)
- Sodium Chloride (NaCl) 0.9 %
Treatment groups
334 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Genentech, Inc.
Collaborator
American Lung Association Asthma Clinical Research Centers
Collaborator
American Lung Association
Collaborator
Source ClinicalTrials.gov