House Dust Mite SLIT in Elderly Patients

Phase 4

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: immunotherapy Staloral

• Registration Number: NCT01605760
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-21
• Last Update Submitted: 2012-05-21
• Study First Posted: 2012-05-25
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non immunotherapy treatment	immunotherapy Staloral	-
sublingual immunotherapy course	immunotherapy Staloral	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline of nasal symptoms after immunotherapy	three year	Assessment of reducing the need for symptom-targeted drugs, primarily antihistamines and reducing of nasal symptoms during treatment in study patients (diary monitoring).

Trial Locations

Locations (1)

Allergology Outpatient Clinic; 🇵🇱 Zabrze, Poland