Sponsor study identifier
interventional
60
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to determine whether exhaled breath temperature, a surrogate marker of airway inflammation, rises during the pollen season in sensitized subjects with allergic rhinoconjucnctivitis with or without mild asthma. Sublingual Immunotherapy with respective allergens suppresses the seasonal increase of EBT. During the second year (2013) of the trial all patients will be treated with 5 grass allergen extract: carry over differences between the active and placebo arms from the previous year (2012) will be looked for.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 1, 2013
Actual (reported)February 7, 2013
Actual (reported)October 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Changes of exhaled breath temperature before and during the pollen season of subjects treated with 5 grass allergen extract sublingually and the untreated control patients.
The primary objective of the study is to evaluate the differences between the changes of exhaled breath temperature before and in the pollen season of subjects treated with 5 grass allergen extract applied sublingually and untreated control patients. Possible carry-over differences between the same two arms will be explored during the second year of the trial. Calculations will involve difference between assessment at month 6 and baseline for year 1 (2012) and in year 2 (2013) and comparisons between the two arms of the study will be made.
6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
Effect of the treatment on symptoms and objective measurements in blood
6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
30 patients will receive the active component 5 grass allergen extract daily during the active pollen season (February-July)
30 patients will receive placebo
30 patients will be subjected to sublingual immunotherapy with 5 grass allergen extract Staloral, starting with 1 spurt of 10 IR/ml increasing them daily stepwise to 10 spurts, switching then to 1 spurt of 300 IR/ml, increasing daily stepwise to 10 spurts, and then maintaining this dose from February till July. 30 patients will be on placebo.
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Medical University Sofia, Department of Allergology
Sofia, 1431, Bulgaria
Xepapadaki P, Xatziioannou A, Chatzicharalambous M, Makrinioti H, Papadopoulos NG. Exhaled breath temperature increases during mild exacerbations in children with virus-induced asthma. Int Arch Allergy Immunol. 2010;153(1):70-4. doi: 10.1159/000301581. Epub 2010 Apr 1.
Popov TA, Kralimarkova T, Tzachev C, Dimitrov V, Mun KK, Gill J. Exhaled breath temperature measurement made easy. Pediatr Allergy Immunol. 2009 Mar;20(2):200-1; author reply 202-3. doi: 10.1111/j.1399-3038.2008.00837.x. Epub 2008 Nov 10. No abstract available.
Todor Popov, MD, PhD
Professor of Allergology
First Submitted
February 1, 2013
First Posted
February 7, 2013
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
Contact the study team to confirm eligibility.
Popov TA, Dunev S, Kralimarkova TZ, Kraeva S, DuBuske LM. Evaluation of a simple, potentially individual device for exhaled breath temperature measurement. Respir Med. 2007 Oct;101(10):2044-50. doi: 10.1016/j.rmed.2007.06.005. Epub 2007 Jul 12.
Braunstahl GJ, Hellings PW. Nasobronchial interaction mechanisms in allergic airways disease. Curr Opin Otolaryngol Head Neck Surg. 2006 Jun;14(3):176-82. doi: 10.1097/01.moo.0000193186.15440.39.
Kralimarkova TZ, Popov TA, Staevska M, Mincheva R, Lazarova C, Racheva R, Mustakov TB, Filipova V, Koleva M, Bacheva K, Dimitrov VD. Objective approach for fending off the sublingual immunotherapy placebo effect in subjects with pollenosis: double-blinded, placebo-controlled trial. Ann Allergy Asthma Immunol. 2014 Jul;113(1):108-13. doi: 10.1016/j.anai.2014.03.019. Epub 2014 Apr 16.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 7, 2013
Record last verified: 2013-02
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