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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
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):

September 13, 2005
September 20, 2005
May 13, 2016
January 2006
October 2008   (Final data collection date for primary outcome measure)
Change in nasal allergy/asthma symptom score over a 4-week period [ Time Frame: baseline and after 12-18 months treatment ]
Change in nasal allergy/asthma symptom score over a 4-week period Spring of 2006 vs Spring of 2007
Complete list of historical versions of study NCT00200850 on ClinicalTrials.gov Archive Site
Not Provided
  • change in above symptom scores for low vs high dose SLIT
  • change in average symptom scores for Fall 2006 vs Fall 2007
Not Provided
Not Provided
Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy
Sublingual Immunotherapy in 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.

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.

Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Biological: Hose Dust Mite SLIT
    low dose SLIT 143 AU/ml daily
  • Biological: High dose SLIT
    House Dust Mite SLIT- 10,000 AU/ml daily
  • Biological: Placebo SLIT
    Placebo SLIT daily
  • Active Comparator: 1
    Low dose SLIT
    Intervention: Biological: Hose Dust Mite SLIT
  • Active Comparator: 2
    High dose SLIT
    Intervention: Biological: High dose SLIT
  • Placebo Comparator: 3
    Intervention: Biological: Placebo SLIT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2008
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R21AT002326-01A1 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Robert K. Bush, MD University of Wisconsin Medical School
University of Wisconsin, Madison
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP