Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00200850
First received: September 13, 2005
Last updated: November 19, 2009
Last verified: November 2009

September 13, 2005
November 19, 2009
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 ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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
    Placebo
    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.
 
Completed
31
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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200850
R21 AT002326-01A1, R21AT002326-01A1
Yes
James Gern, MD, Board of Regents of the University of Wisconsin System
University of Wisconsin, Madison
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Robert K. Bush, MD University of Wisconsin Medical School
University of Wisconsin, Madison
November 2009

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