- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00200850
Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy
Sublingual Immunotherapy in Dust Mite Allergy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53706
- University of Wisconsin Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Placebo SLIT daily
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Active Comparator: Low dose SLIT
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low dose SLIT 143 Allergen Units(AU)/ml daily
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Active Comparator: High dose SLIT
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House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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baseline and after 12-18 months treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert K. Bush, MD, University of Wisconsin Medical School
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2005-0193
- R21AT002326-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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