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

Asthma Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

The prevalence of asthma has dramatically increased in many parts of the world. Currently, there is no effective way to prevent development of allergic rhinitis and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in which allergens are placed under the tongue, may be a way to control and possibly prevent allergic rhinitis and asthma. However, detailed research of this approach is limited.

The purpose of this study is to evaluate the safety and tolerability of a sublingual cockroach extract given to people with perennial allergic rhinitis. Participants in this study will include people both with and without asthma.

Participation in this study will last a little more than 2 weeks. Participants will be stratified by age (oldest to youngest age group) and degree of cockroach sensitivity. Each age group will be enrolled after the previous group's safety data have been reviewed. At study entry (Day 0), participants will receive a dose of placebo and then up to seven incremental doses of cockroach extract at 15-minute intervals while observed by the clinic nurse. Doses will continue to be given until a sign or symptom occurs that indicates the participant is having difficulty tolerating the drug, or until the maximum study dose is reached.

At the Principal Investigator's discretion, participants who were able to achieve the maximum study dose will be invited to continue onto the 2-week treatment course of the study. These participants will return on Days 1 and 2 to the clinic to self-administer the maximum study dose of cockroach extract. After self-administering the maximum study dose, participants will be observed by the clinic nurse for 30 minutes. On Days 3 through 14, participants will take the maximum study dose of cockroach extract daily at home. Participants will be asked to keep a diary and record signs or symptoms experienced after taking each dose.

Skin tests, breathing tests, and blood collection will occur at study screening. At study entry, participants will be taught to use an EpiPen in the event of a severe allergic reaction at any time during the study. A physical exam/fitness assessment will be done at study screening, study entry, and the final visit. Unused extract will be collected at the final visit from participants who entered the 2-week treatment course of the study.

The reference for this study is SCSS (Sublingual Cockroach Safety Study) in the provided citation: Wood RA, Togias A, Wildfire J et al. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. J Allergy Clin Immunol. 2014 Mar;133(3):846-52. PubMed ID: 24184147). ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy
• Asthma
• Hypersensitivity
• Rhinitis, Allergic, Perennial

• NCT number: NCT00434421
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: February 2007
• Completion date: August 2009