Pollinosis Clinical Trial
Official title:
Changes in Exhaled Breath Temperature During the Pollen Season in Subjects With Allergic Rhinoconjunctivitis Sensitized to Grasses and Effect of Sublingual Immunotherapy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment