Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis

NCT ID: NCT03157505

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-05
• Study Completion Date: 2017-03-02

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.

Conditions

Allergic Rhinitis; Allergic Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Purethal Birch immunotherapy

Purethat Birch intervention and symptomatic treatment for 24 months

Group Type: ACTIVE_COMPARATOR

Purethal Birch immunotherapy

Intervention Type: DRUG

Purethal birch was administered as perennial therapy: 24 months

placebo and symptomatic treatment

placebo intervention and symtomatic treatment during 24 months

Group Type: PLACEBO_COMPARATOR

Placebo and symptomatic treatment

Intervention Type: OTHER

symptomatic treatment including: antihitamine drug, nasal dropps and placebo injection

Interventions

Purethal Birch immunotherapy

Purethal birch was administered as perennial therapy: 24 months

Intervention Type: DRUG

Placebo and symptomatic treatment

symptomatic treatment including: antihitamine drug, nasal dropps and placebo injection

Intervention Type: OTHER

Other Intervention Names

allergen specific immunotherapy

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Silesia

OTHER

Sponsor Role: lead

Responsible Party

Andrzej Bozek

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Fisher

Role: STUDY_DIRECTOR

Outpatient Clinic Allergy

References

Rondon C, Romero JJ, Lopez S, Antunez C, Martin-Casanez E, Torres MJ, Mayorga C, R-Pena R, Blanca M. Local IgE production and positive nasal provocation test in patients with persistent nonallergic rhinitis. J Allergy Clin Immunol. 2007 Apr;119(4):899-905. doi: 10.1016/j.jaci.2007.01.006. Epub 2007 Mar 2.

Reference Type: BACKGROUND

PMID: 17337294 (View on PubMed)

Bozek A, Kolodziejczyk K, Jarzab J. Efficacy and safety of birch pollen immunotherapy for local allergic rhinitis. Ann Allergy Asthma Immunol. 2018 Jan;120(1):53-58. doi: 10.1016/j.anai.2017.10.009.

Reference Type: DERIVED

PMID: 29273130 (View on PubMed)

Other Identifiers

605060184JB

Identifier Type: -

Identifier Source: org_study_id