Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
AllergyAsthma
Interventions
DRUG

Glycerinated German cockroach allergenic extract

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.

DRUG

Placebo

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.

Trial Locations (1)

21287

Johns Hopkins University School of Medicine, 600 North Wolfe St, CMSC 1102, Baltimore

All Listed Sponsors
collaborator

Inner-City Asthma Consortium

NETWORK

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00434421 - Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma | Biotech Hunter | Biotech Hunter