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House Dust Mite Sublingual Immunotherapy: a Double-blind, Placebo Control Study in Elderly Patients.
The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick tests, serum-specific IgE and nasal provocation tests were included. Patients were individually randomised to groups: active or placebo using a double-blind method. A total of 51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R, Stallergens, France) and 57 in the placebo group were monitored for three years. The patients had to record on a diary card whenever they used anti-allergic medications.
Details
| Lead sponsor | Medical University of Silesia |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 111 |
| Start date | 2008-01 |
| Completion | 2012-03 |
Conditions
- Allergic Rhinitis
Interventions
- immunotherapy Staloral
Primary outcomes
- Number of participants with adverse event during immunotherapy — three year
Safety assessment of sublingual immunotherapy on the basis of the monitoring clinical adverse events during treatment by the use of a patient diary and medical examination.
Countries
Poland