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
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis Allergic Reaction||Drug: Purethal Birch immunotherapy Other: Placebo and symptomatic treatment||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- area under the curve (AUC) [ Time Frame: 24 months ]area under the curve (AUC) for the combined symptom and medication scores (SMS)
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
|Study Director:||Andreas Fisher||Outpatient Clinic Allergy|