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

Primary Purpose

Allergic Rhinitis, Allergic Reaction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Purethal Birch immunotherapy
Placebo and symptomatic treatment
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Purethal Birch immunotherapy

    placebo and symptomatic treatment

    Arm Description

    Purethat Birch intervention and symptomatic treatment for 24 months

    placebo intervention and symtomatic treatment during 24 months

    Outcomes

    Primary Outcome Measures

    area under the curve (AUC)
    area under the curve (AUC) for the combined symptom and medication scores (SMS)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2017
    Last Updated
    May 16, 2017
    Sponsor
    Medical University of Silesia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03157505
    Brief Title
    Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis
    Acronym
    LARbirch
    Official Title
    Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 5, 2014 (Actual)
    Primary Completion Date
    December 30, 2016 (Actual)
    Study Completion Date
    March 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Silesia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinitis, Allergic Reaction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    78 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Purethal Birch immunotherapy
    Arm Type
    Active Comparator
    Arm Description
    Purethat Birch intervention and symptomatic treatment for 24 months
    Arm Title
    placebo and symptomatic treatment
    Arm Type
    Placebo Comparator
    Arm Description
    placebo intervention and symtomatic treatment during 24 months
    Intervention Type
    Drug
    Intervention Name(s)
    Purethal Birch immunotherapy
    Other Intervention Name(s)
    allergen specific immunotherapy
    Intervention Description
    Purethal birch was administered as perennial therapy: 24 months
    Intervention Type
    Other
    Intervention Name(s)
    Placebo and symptomatic treatment
    Intervention Description
    symptomatic treatment including: antihitamine drug, nasal dropps and placebo injection
    Primary Outcome Measure Information:
    Title
    area under the curve (AUC)
    Description
    area under the curve (AUC) for the combined symptom and medication scores (SMS)
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andreas Fisher
    Organizational Affiliation
    Outpatient Clinic Allergy
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    17337294
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29273130
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis

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