A Pilot Study to Assess Safety and Feasibility of Cockroach Nasal Allergen Challenge in Cockroach Sensitive Children and Adults with Asthma
- CTRC Outpatient
- Children’s Medical Center (Dallas, Plano, Southlake)
- Clements University Hospital
- Parkland Health & Hospital System
- UT Southwestern Ambulatory Services
- UT Southwestern-Other
Rebecca Gruchalla, M.D., Ph.D.
This is a multi[?]center, open label pilot study to assess the safety
and determine the feasibility of cockroach nasal allergen challenge
in children with asthma. This pilot study will occur in two phases.
Phase 1 will enroll 10 cockroach sensitive adults with asthma who
will undergo a nasal allergen challenge with increasing doses of
cockroach allergen. Phase 1 will consist of two parts, Phase 1a and
Phase 1b. in Phase 1a, participants will undergo a nasal allergen
challenge. in Phase 1b, participants will undergo a repeat nasal
allergen challenge to assess reproducibility of the naC with
cockroach allergen in a population with asthma. The data from
Phase 1a will be used to identify a range of doses that is safe and
elicits a threshold of nasal symptoms (TnSS [GreaterThanorequalTo]8). Phase 2 will enroll
25 cockroach sensitive children with asthma ages 8[?]14 years who
will undergo a nasal allergen challenge using the dose range
identified in Phase 1a.