Clinical trial NCT01785394: POLlinosis and Exhaled Breath Temperature
Official title: Changes in Exhaled Breath Temperature During the Pollen Season in Subjects With Allergic Rhinoconjunctivitis Sensitized to Grasses and Effect of Sublingual Immunotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pollinosis
Keywords: pollinosis
sublingual immunotherapy
exhaled breath temperature
Lead sponsor: Association Asthma, Bulgaria
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
Secondary outcomes:
measure: Effect of the treatment on symptoms and objective measurements in blood
timeFrame: 6 months in year 1 (2012): baseline and at month 6; and 6 months in year 2 (2013): baseline and month 6.
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Medical University Sofia, Department of Allergology
Study officials:
affiliation: Professor of Allergology
name: Todor Popov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.