This study will determine the effectiveness of sublingual immunotherapy (SLIT) at two different dosing regimens for patients with house dust mite-induced allergic rhinitis/mild intermittent asthma.

Condition	Intervention	Phase
Asthma	Drug: Sublingual immunotherapy	Phase I

Further Study Details: 

Primary Outcomes: Change in nasal allergy/asthma symptom score over a 4-week period Spring of 2006 vs Spring of 2007
Secondary Outcomes: change in above symptom scores for low vs high dose SLIT; change in average symptom scores for Fall 2006 vs Fall 2007
Expected Total Enrollment:  45

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 leanrn effective treatments for specific types of asthma. Inhaled corticosteroids are the standard treatment for chronic asthma care. However, recent studies have shown that adjunctive immunotherapy can effectively control asthma symptoms as well. This study will determine the safety and effectiveness of sublingual immunotherapy (SLIT) at two different dosing regimens in 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 18 months. Both in vitro and in vivo tests will be used to assess participants at study entry, periodically throughout the study, and at the end of the study. The in vitro tests will be done to examine whether SLIT is effective in shifting the house dust mite-induced immune response away from a Th2 paradigm and toward an immune tolerance state and whether SLIT acts via local mucosal versus systemic immunological effects. The in vivo studies will examine whether subjects will have a prolonged right order shift in the early and late phase responses to SLIT-induced allergy skin test reactions and bronchial allergen challenges as measured by bronchoprovocation after therapy.

Ages Eligible for Study:  18 Years   -   40 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• House dust mite-induced allergic rhinitis/mild intermittent asthma

Exclusion Criteria:

• History of previous allergy immunotherapy to house dust mite
• Pregnant or lactating females

Please refer to this study by ClinicalTrials.gov identifier  NCT00200850

Cheri A Swenson, BS      (608) 262-5189    cas@medicine.wsic.edu
Mary Jo Jackson, RN, BSN      (608) 265-3556    mmj@medicine.wisc.edu

Study chairs or principal investigators

Robert K Bush, MD,  Principal Investigator,  University of Wisconsin Medical School   

Study ID Numbers:  AT002326-01A1
Last Updated:  September 19, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00200850
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20