NCT01529437

Sublingual Immunotherapy Studies for Grass and Dust Mite Allergies

Phase 1 Single Center, Randomized, Controlled Study Using Sublingual Immunotherapy for Timothy Grass and Dust Mite Allergies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergies
• Allergic Rhinitis
• Asthma

Interventions

Type	Name	Description
DRUG	sublingual immunotherapy	Sublingual immunotherapy is provided in an extract form under IND 13485 and dosed safely through a maintenance dose of 12 months.
DRUG	placebo sublingual immunotherapy	SLIT placebo will be the same color and consistency of the active drug arm to provide double blinding

Timeline

• Start date: 2005-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-02-08
• Last updated: 2015-11-26

Locations

1 site across 1 country: United States