Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis

• Status: Completed
• Trial end date: 2017-03-02
• Target enrollment: 0
• Participant gender: All

Summary

Local allergic rhinitis (LAR) is relatively new disease. The question of effect of allergen specific immunotherapy on LAR is open. The randomized, double blind placebo controlled trial of birch subcutaneous AIT on LAR were performed in twenty eight patients. The therapy was performed during 24 months in proportion 15 patients with AIT and 13 placebo. The primary endpoint was decreased of symptoms medication score (SMS). Additionally monitoring serum specific IgE, specific IgG4 and nasal specific IgE (nsIgE) to Bet v1 and parameters of safety and quality of life were provided.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Silesia
• Treatments: Immunologic Factors

Criteria

Inclusion Criteria:

• well document symptoms of rhinitis during birch pollen season

• positive nasal provocation test to birch

• negative results of skin prick tests to inhalant allergen including: D. pteronyssius, D. farinae, grass pollen, birch, hazel, alder Alternaria, and cat.

• negative results of serum total and allergen specific IgE against mentioned allergens.

Exclusion Criteria:

• diagnosis of bronchial asthma, non-allergic rhinitis (especially senile or vasomotor rhinitis) and severe non-stable diseases. All subjects were required to abstain from anti-allergy drugs and glucocorticoid nasal drops for at least 6 weeks prior to the start of the study.