Finding studies
Finding studies
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Lead
Andrew D. Luster, M.D.,Ph.D.
With
This is a single-center, open-label, controlled mechanistic study before-and-after allergen instillation study that uses each subject as his/her own control. Reliability of study measurements of expression is accomplished by comparing repeated measurements. Additional controls are provided by measuring the expression of markers known to have stable expression, including cell structural proteins and chemokine markers that the investigators know are induced in this experimental paradigm from our previous studies. This is an investigational study. Subjects will receive an investigational product, either Standardized Cat Allergen Extract or Standardized Dust Mite Allergen (Dermatophagoides farinae or D. pteronyssinus). No subject will be given a placebo. There are 2 cohorts, allergic asthmatics (AA) and healthy controls (HC). The main comparisons will be measurement of primary and secondary outcome measures in: (1) diluent versus allergen-challenged segments of the lung in each asthmatic subject and (2) comparison of these responses in allergic asthmatics (AA) and healthy controls (HC). The investigators will enroll 20 AA subjects (10 in Track 1 \& 10 in Track 2) and 10 HC subjects (Track 1). There will be no randomization. The choice of allergen will be determined by allergy skin testing. When a subject is allergic to both cat and dust mite, one will be selected with a goal of having a representative sample of cat and dust mite challenges in each cohort. The 10 allergic asthmatic (AA) subjects and HC subjects in Track 1 will undergo preliminary screening tests and provide 200 ml of blood for DC and T cell studies on one occasion. Track 1 subjects will not undergo bronchoscopy, bronchoalveolar lavage, or segmental allergen challenge. The 10 allergic asthmatic (AA) subjects in Track 2 will undergo SAC with either standardized cat or mite allergen. These subjects will also donate 200 ml of blood on two occasions separated by a minimum of 4 weeks and not more than 12 weeks.
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
