House Dust Mite Sublingual Immunotherapy: a Double-blind, Placebo Control Study in Elderly Patients.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse event during immunotherapy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 60 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with allergic rhinitis who fulfilled the ARIA criterion and had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE) and had positive nasal provocation tests (NPTs) by Dermatophagoides pteronyssinus (Der p) and Dermatophagoides farinae (Der f) were included in the study
Exclusion Criteria
- •Patients with any of the following characteristics were excluded:
- •hypersensitivity to other allergens,
- •non-allergic rhinitis (especially senile or vasomotor rhinitis) or
- •severe non-stable diseases (especially bronchial asthma). However, stable coronary disease, diabetes, arterial hypertension and well-controlled, mild or atopic bronchial asthma were permitted.
Arms & Interventions
non immunotherapy treatment
Intervention: immunotherapy Staloral (Drug)
sublingual immunotherapy course
Intervention: immunotherapy Staloral (Drug)
Outcomes
Primary Outcomes
Number of participants with adverse event during immunotherapy
Time Frame: 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.
Secondary Outcomes
- Change from baseline of nasal symptoms after immunotherapy(three year)
Investigators
Andrzej Bozek
Medical Doctor
Medical University of Silesia