House Dust Mite SLIT in Elderly Patients

Medical University of Silesia

Status and phase

Completed

Phase 4

Conditions

Allergic Rhinitis

Treatments

Drug: immunotherapy Staloral

Study type

Interventional

Funder types

Other

Identifiers

NCT01605760

657898/2008

Details and patient eligibility

About

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.

Enrollment

111 patients

Sex

All

Ages

60 to 75 years old

Volunteers

No Healthy Volunteers

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.