Clinical Research Directory

Immune Defense Protein Impact On Respiratory Immune Outcomes

The primary goal of this study is to observe the impact of the IDP® Supplement on the duration and severity of upper respiratory symptoms in older individuals during the cold and flu season. Secondary aims include observing the product's effect on rescue medication use, quality of life, and overall tolerability. This is conducted as a consumer-driven, decentralized observational clinical research study in adults aged 60 or older, using self-reported measures and questionnaires completed at home via the Chloe App.

Omalizumab Before Onset of Exacerbations

OBOE is a prospective, pilot, parallel group RCT with the overall aim of examining the effect of a single dose of anti-IgE (omalizumab) vs. placebo administered at the onset of URIs in the fall season among highly exacerbation-prone, urban, and atopic youth aged 6-17 years with persistent asthma. OBOE will recruit and randomize participants over 3 years (3 annual cohorts of participants). Recruitment for each of the yearly cohorts of OBOE will begin in February. Each cohort will be followed for a 2-6-month run-in period with the objective to gain control of each participant's asthma and to stabilize the required controller medication step level. Participants will receive routine asthma care every 1-2 months (a total of 2-4 times) during run-in using a previously described algorithm developed by the Inner-city Asthma Consortium and successfully employed in the PROSE study. The primary outcome is the change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, within 72 hours of onset of a URI as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) and 3-6 days after study drug injection.