CLINICAL TRIAL: PHASE 1 STUDY OF DERMATOPHAGOIDES FARINAE INHALATION IN HUMANS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This will be a non-blinded study of the effect of inhaled dust mite allergen extract (Dermatophagoides Farinae or D Farinae ) on airway responses in 15 mild allergic asthmatic subjects. The principal endpoint will be a decrease in FEV1 of 15% from baseline measurements (obtained immediately prior to challenge) within 10 minutes after inhalation of one of a series of increasing allergen doses. The doses will delivered as 5 inhalations of allergen at increasing concentrations of inhaled D Farinae allergen extract. Sputum samples will be analyzed and compared at 24 hours post challenge versus the baseline sample. At 4 hours post allergen challenge, we will measure mucociliary clearance (MCC) of inhaled, radiolabeled particles by gamma scintigraphy as an exploratory endpoint. It is expected that mucociliary clearance will be depressed as part of a late phase reaction to allergen challenge. Comparisons will be made with MCC obtained from the same subject during the baseline visit for this protocol.