drugset / Trial / NCT03209245

House Dust Mite Injection Immunotherapy in Elderly Patients.

NCT03209245 ↗

Phase 3 Completed 58 enrolled Medical University of Silesia
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator PURETHAL Mites Unknown 0.5 ml Subcutaneous

Indications

No indication recorded.