NCT03157505

Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Local allergic rhinitis (LAR) is still an under diagnosed and under treated disease. It is characterised by local production of IgE during natural exposure to aeroallergens. These patients have negative skin prick tests and serum-specific IgEs but have positive nasal provocation tests for aeroallergens. More than 50% of patients with chronic non-allergic rhinitis may have a problem with lack of LAR diagnosis. Misdiagnosis can lead to mistakes in the treatment as well as inefficiencies. Besides on only local IgE-mediated reaction, allergen immunotherapy (AIT) could be a potential way of treatment such patients. However, there are only sufficient data that the AIT is effective in allergic rhinoconjunctivitis and asthma to pollens and house dust mites and some animal. The aim of this study was to assess the safety and efficacy of AIT for birch pollen allergens in patients with local allergic rhinitis and a confirmed birch pollen allergy.

Conditions

• Allergic Rhinitis
• Allergic Reaction

Interventions

Type	Name	Description
DRUG	Purethal Birch immunotherapy	Purethal birch was administered as perennial therapy: 24 months
OTHER	Placebo and symptomatic treatment	symptomatic treatment including: antihitamine drug, nasal dropps and placebo injection

Timeline

• Start date: 2014-01-05
• Primary completion: 2016-12-30
• Completion: 2017-03-02
• First posted: 2017-05-17
• Last updated: 2017-05-17