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.
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.
Status: Completed (N/A). Started on January 1st, 2006.
Enrollment: 31 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Safety/Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Double Blind (Subject
- Caregiver
- Investigator
- Outcomes Assessor)
- Primary Purpose: Treatment
Conditions:
Interventions:
- Biological: Hose Dust Mite SLIT
- Biological: High dose SLIT
- Biological: Placebo SLIT
Eligibility
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
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
50 Years
- Healthy Volunteers
No
Resources
Source: University of Wisconsin, Madison
Authority: United States: Federal Government
Locations
-
University of Wisconsin Medical School
Madison
Wisconsin
53706
United States
Officials
Robert K. Bush, MD (Principal Investigator, University of Wisconsin Medical School)
Sponsors
University of Wisconsin, Madison (Lead Sponsor)
National Center for Complementary and Alternative Medicine (NCCAM) (Collaborator)
References
None.
Links
None.
- Date Verified
- November 1st, 2009
- First Received
- November 19th, 2009
- Last Changed
- November 19th, 2009
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.
The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.