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House Dust Mite Injection Immunotherapy in Elderly Patients.

NCT03209245 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-07-06

No results posted yet for this study

Summary

Background. Immunotherapy in elderly patients is controversial, and there is still not much evidences supporting this treatment's safety and efficacy in this population. This study was performed to evaluate the safety and efficacy of specific injection immunotherapy for house dust mite allergens in patients over 65 years of age with allergic rhinitis and a confirmed allergy to house dust mites. The primary endpoint was the change from baseline in the mean average adjusted symptom score (AAdSS) and the total combined rhinitis score (TCRS) difference in the least square means in the label in comparison to placebo.

Materials and methods. The study with double blind, placebo controlled trial was conducted in one centre. Fifty eight elderly patients with house dust mites allergy and AR were individually randomized in comparable numbers to one of two parallel groups: two years perennial AIT with the use Purethal Mites or placebo. Symptoms and medication score were presented as AAdSS and TCRS. Quality of life based on Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), serum allergen specific IgG4 to D.pteronyssinus and D. farinae and Der p1 and Der p2 were monitoring.

Conditions

  • Allergen Immunotherapy in Elderly Patients

Interventions

BIOLOGICAL

Purethal Mites

perennial allergren specific immunotherapy during 24 months

OTHER

placebo injection

perrenial injection wich were administered in same protocol as Purethal

DIAGNOSTIC_TEST

monitoring of allergen specific IgE

measurement the serum specific IgE at the start and at the end of trial

DIAGNOSTIC_TEST

monitoring of allergen specific IgG4

measurement the serum specific IgG4 at the start and at the end of trial

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-10
Primary Completion
2016-06-20
Completion
2017-04-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209245 on ClinicalTrials.gov