A Pilot Study to Assess Safety and Feasibility of Cockroach Nasal Allergen Challenge in Cockroach Sensitive Children and Adults with Asthma

Study ID
STU 012016-026

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • CTRC Outpatient
  • Children’s Medical Center (Dallas, Plano, Southlake)
  • Clements University Hospital
  • Parkland Health & Hospital System
  • UT Southwestern Ambulatory Services
  • UT Southwestern-Other

Contact
Dolores Santoyo
214/648-2620
DOLORES.SANTOYO@UTSouthwestern.edu

Principal Investigator
Rebecca Gruchalla, M.D., Ph.D.

Summary

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.

Participant Eligibility