Cockroach Immunotherapy in children and adolescents
Study ID: STU 052018-049
The study will occur in two parts. Part a will enroll 80 children from 8-14 years of age who are sensitized to cockroach and have asthma and a positive cockroach nasal allergen Challenge(naC)before randomization. an interim analysis will be conducted when all Part a participants have completed their 12 month naC. if an effect is seen for the part a naC analysis. The study will proceed to Part B. Part B will enroll 220 children from 6-16 years of age who are sensitized to cockroach and have asthma. a positive naC will not be required for inclusion into part B.
The primary objective of the study is to determine if asthma severity, as measured by the Composite asthma Severity index (CaSi), can be improved with treatment with cockroach subcutaneous immunotherapy (SCiT)Secondary objectives are to assess safety of cockroach immunotherapy in children and adolescents, to assess changes in nasal allergen Challenge outcomes in children with a positive naC at screening, to assess the effect of cockroach SCiT on asthma severity measures a part from CaSi, To assess the effect of cockroach SCiT on rhinitis symptoms and medication requirements