NCT03644680|CompletedDMC
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Sponsor study identifier
interventional
36
1 country
1
Study Start
September 24, 2018
Actual (reported)Primary Completion
October 4, 2019
Actual (reported)Study Completion
October 4, 2019
Actual (reported)IgE-associated allergy is a hypersensitivity disease affecting more than 25% of the population in industrialised countries. The recognition of allergen by immunoglobulin E (IgE) plays a central role in the cause of allergic diseases. Both seasonal and nasal provocation studies have demonstrated the rise in specific IgE after allergen exposure. Additionally changes in other clinical and immunological parameters (e.g. nasal blockage, mast cell and basophil sensitivity, various cytokines or T cell profiles) in response to allergen exposure have been described. However the time sensitive interplay of these various factors such as the relationship between rise in IgE levels and change in basophils sensitivity or cytokine profiles is not yet fully understood. Clarifying how these various factors interact and contribute to immunological responses to allergen, is crucial for the development of new therapeutic approaches. The investigators aim to address these questions through a study following 36 Birch allergic patients after provocation with allergen or placebo over a peroid of 6 weeks to 1 year.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 4, 2019
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.
July 26, 2018
Actual (reported)August 23, 2018
Actual (reported)September 24, 2018
Actual (reported)October 4, 2019
Actual (reported)October 4, 2019
Actual (reported)Allergen Specific IgE Rise
To assess changes of allergen specific IgE levels after challenge with Birch pollen extract
1 Year
IgE Levels in Nasal Secretions
1 Year
Total IgE Levels
1 Year
Assessing Immunoglobin Isotypes
1 Year
Changes in TH2 Cytokine patterns.
1 Year
IgE Production
1 Year
Birch allergic patient receiving 3 consecutive nasal challenges with birch extract (Allergopharma). Total dose of 1.5ug of Bet v 1 per challenge
Birch allergic patient receiving 3 consecutive nasal challenges with sterile NaCl 0.9%. Total dose of 100ul per nostril per challenge
Nasal spray containing birch extract from Allergopharma
Nasal spray containing sterile sodium chloride 0.9%
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
8H1.02, ENT Lab, Department of Otorhinolaryngology, Vienna General Hospital
Vienna, 1090, Austria
Wuthrich B, Schindler C, Leuenberger P, Ackermann-Liebrich U. Prevalence of atopy and pollinosis in the adult population of Switzerland (SAPALDIA study). Swiss Study on Air Pollution and Lung Diseases in Adults. Int Arch Allergy Immunol. 1995 Feb;106(2):149-56. doi: 10.1159/000236836.
Bischoff SC. Role of mast cells in allergic and non-allergic immune responses: comparison of human and murine data. Nat Rev Immunol. 2007 Feb;7(2):93-104. doi: 10.1038/nri2018.
Josef Toth, MD
ENT Specialist
36 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2018
First Posted
August 23, 2018
Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis
Contact the study team to confirm eligibility.
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Campana R, Moritz K, Marth K, Neubauer A, Huber H, Henning R, Blatt K, Hoermann G, Brodie TM, Kaider A, Valent P, Sallusto F, Wohrl S, Valenta R. Frequent occurrence of T cell-mediated late reactions revealed by atopy patch testing with hypoallergenic rBet v 1 fragments. J Allergy Clin Immunol. 2016 Feb;137(2):601-609.e8. doi: 10.1016/j.jaci.2015.08.042. Epub 2015 Oct 28.
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Egger C, Lupinek C, Ristl R, Lemell P, Horak F, Zieglmayer P, Spitzauer S, Valenta R, Niederberger V. Effects of nasal corticosteroids on boosts of systemic allergen-specific IgE production induced by nasal allergen exposure. PLoS One. 2015 Feb 23;10(2):e0114991. doi: 10.1371/journal.pone.0114991. eCollection 2015.
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Shamji MH, Bellido V, Scadding GW, Layhadi JA, Cheung DK, Calderon MA, Asare A, Gao Z, Turka LA, Tchao N, Togias A, Phippard D, Durham SR. Effector cell signature in peripheral blood following nasal allergen challenge in grass pollen allergic individuals. Allergy. 2015 Feb;70(2):171-9. doi: 10.1111/all.12543.
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Study Start
September 24, 2018
Actual (reported)Primary Completion
October 4, 2019
Actual (reported)Study Completion
October 4, 2019
Actual (reported)Last Updated
October 10, 2019
Record last verified: 2018-11
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