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Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis

NCT03157505 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2017-05-17

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis
  • Allergic Reaction

Interventions

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

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Principal Investigators

  • Andreas Fisher · Outpatient Clinic Allergy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-05
Primary Completion
2016-12-30
Completion
2017-03-02

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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 NCT03157505 on ClinicalTrials.gov