Sublingual Immunotherapy Studies for Grass and Dust Mite Allergies

Phase 1

Completed

• Conditions: Allergies; Allergic Rhinitis; Asthma
• Interventions: Drug: sublingual immunotherapy; Drug: placebo sublingual immunotherapy

• Registration Number: NCT01529437
• Lead Sponsor: Stanford University

Brief Summary

This is a study for children and adults who are interested in a new therapy for their allergies to dust mite and timothy grass. The new therapy is called sublingual immunotherapy and the investigators are testing if it is safe and well tolerated.

Detailed Description

This is a phase I, single-center, randomized, placebo-controlled study of sublingual immunotherapy (SLIT) in pediatric and adult subjects with both house dust mite (HDM) and timothy grass (TG) allergies. We will evaluate whether Dermatophagoides farinae (DF) and/or TG allergen SLIT is safe in children and adults. We will also determine whether treatment with DF and/or TG SLIT reduces the severity of allergic symptoms (allergic rhinitis, allergic conjunctivitis) and enhances their resolution. The study will also evaluate whether SLIT provides a robust durability of response once it is terminated. The dosing-phase of the study will last up to 12 months. In addition, a follow up period of 2 years will occur. Approximately 10 subjects will be on placebo, and 20 on active treatment.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-08
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual immunotherapy	sublingual immunotherapy	Subjects will take sublingual immunotherapy who have dust mite and timothy grass allergies
placebo arm	sublingual immunotherapy	The placebo arm will be double blinded and is an important control in SLIT therapies
placebo arm	placebo sublingual immunotherapy	The placebo arm will be double blinded and is an important control in SLIT therapies

Primary Outcome Measures

Name	Time	Method
Primary Outcome is safety	2008-2014 (6 years)	We will assess safety outcomes according to GCP/CFR and NIAID guidelines
The number of adverse events in the placebo vs the treatment arm will be compared	2008-2016	Adverse events will be defined by GCP/CFR and by NIAID guidelines.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States