Standardized Phleum pratense in TBU/ml in liquid formulation for sublingual immunotherapy: Phase II, randomized dose determination clinical trial. DEDO-G Study.

Allergic rhinitis/rhinoconjunctivitis caused by grass polen allergy

The individual response of each recruited subject to the nasal provocation test (NPT). To objectively assess the response, the change in Nasal Inspiratory Peak Flow (NIPF) will be measured using a portable nasal inspiratory flow meter provided by the Sponsor, and the test will be considered positive if the reduction in NIPF is ≥ 40%. In addition, a clinical assessment will be performed based on the total sum of symptoms on a scoring scale with a maximum of 13 points.

Determination of systemic and/or local adverse reactions associated with the trial, particularly those related to investigational product/placebo, and those due to the nasal provocation test or skin prick test., Rescue medication used throughout the study in relation to the investigational product/placebo (this does not include any rescue medication that may be administered after the nasal provocation test or skin prick test)., Laboratory determinations of serum markers at baseline and end of study: Specific IgE to Phleum pratense and major allergens rPhl p1 + rPhl p5b., y Phleum pratense IgG4., Phleum pratense skin prick test at baseline and end of study for comparative analysis, Independent analysis of each of the clinical variables included in the nasal provocation test scoring scale

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