At a glance
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A Pilot Study to Assess Safety and Feasibility of Cockroach Nasal Allergen Challenge in Cockroach Sensitive Children and Adults With Asthma (ICAC-27)
In Brief
A Phase 1 clinical trial evaluating Glycerinated German Cockroach Allergenic Extract for Asthma and Cockroach Hypersensitivity. Completed, enrolled 35 participants across 4 sites.
Detailed Summary
This research is being done to look at the body's response to cockroach extract, an allergen, when sprayed into the nose. The spraying of the cockroach extract into the participant's nose is called Nasal Allergen Challenge (NAC). The purpose of this study is to evaluate the safety and tolerability of a intranasal cockroach extract given to participants with asthma.
Study Details
Timeline
Interventions
Participants will receive escalating doses intranasally. Briefly: per protocol- Phase 1a NAC: N=10 cockroach sensitive adults with asthma will undergo nasal allergen challenge with dose escalation (up to 8 doses per protocol). Phase 1b: Phase 1a subjects will have repeat NAC with dose escalation (up to 8 doses). Phase 2: N=25 cockroach sensitive children with asthma (ages 8 - 14 years) will undergo NAC with doses determined by Phase 1a data (e.g., symptoms and safety data).