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Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis (LARbirch)

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ClinicalTrials.gov Identifier: NCT03157505
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Andrzej Bozek, 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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Allergic Reaction Drug: Purethal Birch immunotherapy Other: Placebo and symptomatic treatment Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis
Actual Study Start Date : January 5, 2014
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : March 2, 2017

Arm Intervention/treatment
Active Comparator: Purethal Birch immunotherapy
Purethat Birch intervention and symptomatic treatment for 24 months
Drug: Purethal Birch immunotherapy
Purethal birch was administered as perennial therapy: 24 months
Other Name: allergen specific immunotherapy

Placebo Comparator: placebo and symptomatic treatment
placebo intervention and symtomatic treatment during 24 months
Other: Placebo and symptomatic treatment
symptomatic treatment including: antihitamine drug, nasal dropps and placebo injection




Primary Outcome Measures :
  1. area under the curve (AUC) [ Time Frame: 24 months ]
    area under the curve (AUC) for the combined symptom and medication scores (SMS)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157505


Sponsors and Collaborators
Medical University of Silesia
Investigators
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Study Director: Andreas Fisher Outpatient Clinic Allergy

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrzej Bozek, MD PhD, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03157505     History of Changes
Other Study ID Numbers: 605060184JB
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Immunologic Factors
Rhinitis
Rhinitis, Allergic
Hypersensitivity
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Physiological Effects of Drugs