NCT03157505|CompletedPhase 3DMC
Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis
LARbirch
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Sponsor study identifier
interventional
78
0 countries
N/A
Study Start
January 5, 2014
Actual (reported)Primary Completion
December 30, 2016
Actual (reported)Study Completion
March 2, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 5, 2014
Actual (reported)December 30, 2016
Actual (reported)March 2, 2017
Actual (reported)May 15, 2017
Actual (reported)May 17, 2017
Actual (reported)area under the curve (AUC)
area under the curve (AUC) for the combined symptom and medication scores (SMS)
24 months
Purethat Birch intervention and symptomatic treatment for 24 months
placebo intervention and symtomatic treatment during 24 months
Purethal birch was administered as perennial therapy: 24 months
symptomatic treatment including: antihitamine drug, nasal dropps and placebo injection
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.
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.
Andreas Fisher
Outpatient Clinic Allergy
78 participants (actual enrollment reported by the registry).
First Submitted
May 15, 2017
First Posted
May 17, 2017
Study Start
January 5, 2014
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 30, 2016
Actual (reported)Study Completion
March 2, 2017
Actual (reported)Last Updated
May 17, 2017
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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