Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis

Phase 3

Completed

• Conditions: Allergic Rhinitis; Allergic Reaction
• Interventions: Drug: Purethal Birch immunotherapy; Other: Placebo and symptomatic treatment

• Registration Number: NCT03157505
• Lead Sponsor: Medical University of Silesia

Brief 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.

Study Timeline

• Study Start: 2014-01-05
• Primary Completion: 2016-12-30
• Study Completion: 2017-03-02
• Status Verified: 2017-05
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Purethal Birch immunotherapy	Purethal Birch immunotherapy	Purethat Birch intervention and symptomatic treatment for 24 months
placebo and symptomatic treatment	Placebo and symptomatic treatment	placebo intervention and symtomatic treatment during 24 months

Primary Outcome Measures

Name	Time	Method
area under the curve (AUC)	24 months	area under the curve (AUC) for the combined symptom and medication scores (SMS)