Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis

Allergic Rhinitis Clinical Trial

— LARbirch  

Official title:

Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157505
• Other study ID #: 605060184JB
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2017
• Last updated: May 16, 2017
• Start date: January 5, 2014
• Est. completion date: March 2, 2017

Study information

• Verified date: May 2017
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Reaction
• Allergic Rhinitis
• Hypersensitivity
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

References & Publications (1)

Rondón C, Romero JJ, López S, Antúnez C, Martín-Casañez 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. Epub 2007 Mar 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	area under the curve (AUC)	area under the curve (AUC) for the combined symptom and medication scores (SMS)	24 months