Allergic Rhinitis Clinical Trial
— LARbirchOfficial title:
Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis
Verified date | May 2017 |
Source | Medical University of Silesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Medical University of Silesia |
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
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 |
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