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
  Purpose

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 Intervention
Asthma
Biological: Hose Dust Mite SLIT
Biological: High dose SLIT
Biological: Placebo SLIT

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
Official Title: Sublingual Immunotherapy in Dust Mite Allergy

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: January 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Low dose SLIT
Biological: Hose Dust Mite SLIT
low dose SLIT 143 AU/ml daily
Active Comparator: 2
High dose SLIT
Biological: High dose SLIT
House Dust Mite SLIT- 10,000 AU/ml daily
Placebo Comparator: 3
Placebo
Biological: Placebo SLIT
Placebo SLIT daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200850

Locations
United States, Wisconsin
University of Wisconsin Medical School
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Robert K. Bush, MD University of Wisconsin Medical School
  More Information

No publications provided

Responsible Party: James Gern, MD, Board of Regents of the University of Wisconsin System
ClinicalTrials.gov Identifier: NCT00200850     History of Changes
Other Study ID Numbers: R21 AT002326-01A1, R21AT002326-01A1
Study First Received: September 13, 2005
Last Updated: November 19, 2009
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
Breathing
Allergy
Mites, House Dust

ClinicalTrials.gov processed this record on October 23, 2014