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Completed

NCT Number: NCT00200850

Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Medical School

Madison, Wisconsin, 53706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

House Dust Mite SLIT

Biological

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

High dose SLIT

Biological

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

Placebo SLIT

Biological

Placebo SLIT daily

Primary outcomes

  1. Bronchial Threshold to Allergen Challenge From Baseline to 12-18 Months of Treatment

    Time frame: baseline and after 12-18 months treatment

    Antigen challenge was performed using the antigen house dust mite. Increasing doses of antigen were inhaled and then lung function (using the procedure Spirometry, measuring Forced Expiatory Volume in the 1st second FEV1) was measured after each dose. The challenge was stopped once the lung function (FEV1) was dropped by 20% of percent predicted. The dose of antigen that caused a 20% drop in lung function is considered the bronchial threshold. The higher the dose of antigen that causes the drop in lung function, the higher tolerance a participant has of inhaling house dust mite. This dose was measure at baseline and then again after 12-18 months of treatment with sublingual house dust mite antigen.Cumulative breath units is the unit of measure to indicate how much antigen is tolerated before the FEV1 is dropped by 20%. Cumulative breath units is also known as breath units.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Sublingual Immunotherapy in Dust Mite Allergy

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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