At a glance
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A Safety and Pilot Dosing Study for Sublingual-Oral Administration of Glycerinated German Cockroach Allergenic Extract in Pediatric and Adult Subjects With Cockroach Allergy and Perennial Allergic Rhinitis With or Without Asthma
In Brief
A Phase 1 clinical trial evaluating Glycerinated German cockroach allergenic extract and Placebo for Allergy and Asthma. Completed, enrolled 28 participants across 1 site.
Detailed Summary
Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance and adverse events with subcutaneous allergen immunotherapy have generated interest in delivering immunotherapy sublingually (under the tongue). The purpose of this study is to evaluate the safety of a cockroach extract given sublingually to people with perennial (year-round) allergic rhinitis, with or without asthma.
Study Details
Timeline
Interventions
Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters \[mL\], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose \[0.42 mL, 1:10 wt/vol\] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
Placebo was administered only as the first dose (e.g., representing no Glycerinated German Cockroach bioequivalent allergy units) during the initial 1-day, 8-dose escalation, otherwise referred to as the Preliminary Dosing Visit. Refer to the Glycerinated German cockroach allergenic extract treatment for more details. Route of administration: sublingual-oral route.