- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01785394
POLlinosis and Exhaled Breath Temperature (POLET)
Changes in Exhaled Breath Temperature During the Pollen Season in Subjects With Allergic Rhinoconjunctivitis Sensitized to Grasses and Effect of Sublingual Immunotherapy
Study Overview
Detailed Description
Patients with grass pollen allergy are most typical and best responding to sublingual immunotherapy. Their selection will be done in accordance with the criteria listed in Chapter 9 of the World Allergy Organization Position Paper on specific immunotherapy 2009 and in compliance with the rules for good clinical practice.
Proposed primary variable: the difference between the changes of exhaled breath temperature before and in the pollen season of subjects treated with grass-pollen sublingual immunotherapy and the untreated control patients.
Suggested secondary variables: changes over time of exhaled breath temperature in the two groups, difference in symptoms scores, methacholine responsiveness, rescue medication usage.
Statistical analysis: On the basis of the available data about the variability of exhaled breath changes and its changes upon flare up of airway inflammation or after anti-inflammatory treatment we have calculated a sample size of 20 subjects in each group to be sufficient to prove differences in the primary variable with a significance level <0.05. However, as this is "first time ever" type of pilot study on sublingual immunotherapy and exhaled breath temperature in grass-pollen patients, this estimate is relative. By all means this study will identify trends to be used for sample size calculations in future studies. During the second year of the study when all patients will be on active treatment with 5 grass allergen extract, carry over effects from the first year of treatment with 5 grass allergen extract or placebo on exhaled breath temperature will be explored.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Sofia, Bulgaria, 1431
- Medical University Sofia, Department of Allergology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 60 randomized patients from either sex
- age range 5-55 years
- included patients should have a proven grass pollen sensitization
Exclusion Criteria:
- age under or above the stated
- lack of any other concomitant allergen sensitivities that may blur the clinical course of the natural exacerbation due to pollen
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 5 grass allergen extract
30 patients will receive the active component 5 grass allergen extract daily during the active pollen season (February-July)
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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.
Other Names:
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Placebo Comparator: Placebo
30 patients will receive placebo
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
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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.
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6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Effect of the treatment on symptoms and objective measurements in blood
Time Frame: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
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Changes over time of exhaled breath temperature in the two groups, difference in symptoms scores, methacholine responsiveness, rescue medication usage, changes in blood cell counts, C-reactive protein, IL13 and periostin will be calculated (difference between assessment at month 6 and baseline) for year 1 (2012) and Year 2 (2013) and compared between the two arms of the study.
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6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Todor Popov, MD, PhD, Professor of Allergology
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POLET-12-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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