Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy

NCT ID: NCT00200850

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-10-31

Brief Summary

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.

Detailed 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low dose SLIT

Low dose SLIT

Group Type: ACTIVE_COMPARATOR

House Dust Mite SLIT

Intervention Type: BIOLOGICAL

low dose SLIT 143 Allergen Units(AU)/ml daily

High dose SLIT

High dose SLIT

Group Type: ACTIVE_COMPARATOR

High dose SLIT

Intervention Type: BIOLOGICAL

House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo SLIT

Intervention Type: BIOLOGICAL

Placebo SLIT daily

Interventions

House Dust Mite SLIT

low dose SLIT 143 Allergen Units(AU)/ml daily

Intervention Type: BIOLOGICAL

High dose SLIT

House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily

Intervention Type: BIOLOGICAL

Placebo SLIT

Placebo SLIT daily

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert K. Bush, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Medical School

Locations

University of Wisconsin Medical School

Madison, Wisconsin, United States

Countries

United States

References

Bush RK, Swenson C, Fahlberg B, Evans MD, Esch R, Morris M, Busse WW. House dust mite sublingual immunotherapy: results of a US trial. J Allergy Clin Immunol. 2011 Apr;127(4):974-81.e1-7. doi: 10.1016/j.jaci.2010.11.045. Epub 2011 Feb 18.

Reference Type: RESULT

PMID: 21333346 (View on PubMed)

Other Identifiers

R21AT002326-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-2005-0193

Identifier Type: -

Identifier Source: org_study_id