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Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00200850
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Asthma Biological: House Dust Mite SLIT Biological: High dose SLIT Biological: Placebo SLIT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sublingual Immunotherapy in Dust Mite Allergy
Actual Study Start Date : January 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Low dose SLIT
Low dose SLIT
Biological: House Dust Mite SLIT
low dose SLIT 143 Allergen Units(AU)/ml daily

Active Comparator: High dose SLIT
High dose SLIT
Biological: High dose SLIT
House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily

Placebo Comparator: Placebo
Placebo
Biological: Placebo SLIT
Placebo SLIT daily




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200850


Locations
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United States, Wisconsin
University of Wisconsin Medical School
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Robert K. Bush, MD University of Wisconsin Medical School
Publications of Results:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00200850    
Other Study ID Numbers: H-2005-0193
R21AT002326-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Results First Posted: June 12, 2019
Last Update Posted: June 12, 2019
Last Verified: May 2019
Keywords provided by University of Wisconsin, Madison:
Breathing
Allergy
Mites, House Dust
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases