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

Condition studied

Allergic rhinitis/rhinoconjunctivitis caused by grass polen allergy

Investigational medicinal product(s)

Eligibility

Primary endpoint

The individual response of each recruited subject to the Nasal Provocation Test (NPT). NPT response will be assessed using objective and subjective parameters. Objective assessment will be based on changes in Nasal Inspiratory Peak Flow (NIPF), while subjective assessment will be based on the Total Nasal Symptom Score (TNSS, 0–12). NPT positivity will be determined according to protocol-defined criteria.

Endpoint detail

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