Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy

University of Wisconsin (UW)

Status: Completed

Conditions: Asthma

Treatments: Biological: Placebo SLIT; Biological: House Dust Mite SLIT; Biological: High dose SLIT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00200850

R21AT002326-01A1 (U.S. NIH Grant/Contract)

H-2005-0193

Details and patient eligibility

About

This study will investigate sublingual immunotherapy (SLIT), a treatment involving antigens placement under the tongue to help asthma sufferers build a tolerance to the allergy-causing substances. Specifically, this study will determine the effectiveness of SLIT at two different dosing regimens for patients with intermittent mild asthma caused by dust mites.

Full description

Asthma is a serious lung condition that is the leading cause of long-term illness in children. Many common household substances can trigger or worsen an asthma attack. It is important for people to reduce household allergens and learn effective treatments for specific types of asthma. Inhaled short-acting beta agonist such as albuterol is the standard treatment for mild, intermittent asthma. However, recent studies have shown that adding allergen-specific immunotherapy to your current asthma therapy can help to control asthma symptoms. This study will determine the safety and effectiveness of SLIT in two different dosing regimens in treating patients with house dust mite-induced allergic rhinitis/mild intermittent asthma.

Participants will be randomly assigned to receive low dose SLIT, high dose SLIT, or placebo for at least 12 months. House dsut mite-induced allergy skin tests will be performed at study entry, at selected timepoints throughout the study, and at the end of the study. The tests will determine whether SLIT creates an immune tolerance state as well as whether SLIT acts via local or systemic immunological systems.

Enrollment: 31 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• House dust mite-induced allergic rhinitis/mild intermittent asthma

Exclusion criteria

• Use of previous allergy immunotherapy for house dust mite asthma
• Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 3 patient groups, including a placebo group

Low dose SLIT

Active Comparator group

Description:

Low dose SLIT

Treatment:

Biological: House Dust Mite SLIT

High dose SLIT

Active Comparator group

Description:

High dose SLIT

Treatment:

Biological: High dose SLIT

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo SLIT