Pilot study on asthma control in patients with grass- pollen allergic rhinitis treated with 5 grass-pollen sublingual immunotherapy (Staloral®) vs placebo

INTERVENTION: Trade Name: Staloral Pollens maintenance 300 IR/ml sublingual solution Pharmaceutical Form: Sublingual spray, solution Pharmaceutical form of the placebo: Sublingual spray, solution Route of administration of the placebo: Sublingual use CONDITION: Respiratory Allergy: Asthma and allergic rhinitis due to grass pollen Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: Assess asthma control by means of the score difference according to the Composite Asthma Severity Index (CASI)10, which measures and assesses in a multidimensional form the nature of the asthma. This difference will be assessed with respect to the baseline value and between the two treatment groups (Staloral® vs placebo), in patients with grass‐pollen allergic rhinitis, after two seasons of treatment Primary end point(s): Composite Asthma Severity Index (CASI) Secondary Objective: Clinical assessment of asthma and rhino‐conjunctivitis in the two treatment groups after the first and second seasons of treatment. Assess the percentage of patients who improve in asthma control (those who pass from partially controlled to well controlled or pass from badly controlled to partially controlled) and who, moreover, maintain or improve in the therapeutic stage of asthma treatment (1‐6). ; Assessment of quality of life and satisfaction with regard to treatment.; Evaluate changes in serum markers (baseline and final): IgE and IgG4 against Php p 1, Php p 5, Php p 7 +12 and explore the response to immunotherapy through variation dependent innate immune markers of dendritic cells as Programmed Cell Death Ligand 1 (PD‐L1) or Stabilin 1 (STAB1).; Assess the safety profile of treatment with Staloral®.; Rating of pollination within the study period and correlation with symptoms and disease control in both groups. Timepoint(s) of evaluation of this end point: AT THE END OF THE STUDY SECONDARY OUTCOME: Secondary end point(s): Clinical assessment of asthma.; Clinical assessment of the rhinoconjunctivitis.; Evaluate changes in serum markers (baseline and final); Evaluate the safety profile of the STALORAL® treatment.; Pollination in the period of the study and correlation with the symptoms; and control of the disease in both groups Timepoint(s) of evaluation of this end point: AT THE END OF THE STUDY INCLUSION CRITERIA: ? Patients of both sexes aged at 12 years of age or over. ? Patients with rhinitis or allergic rhino‐conjunctivitis who, moreover, suffer asthma due to grass?pollen allergy and present clinical manifestations of asthma during grass‐pollen pollination periods (May to July). ? Patients who have had persistent rhinitis of moderate or severe intensity during the past year, according to the ARIA classification modified by Valero et al.11 ? Patients with a clinical diagnosis of allergic respiratory disease, asthma and rhinitis or rhino‐conjunctivitis, of at least two years evolution. ? Patients with persistent, mild or moderate allergic asthma (GEMA 2009 guide), in which an etiological relation is established with allergy to grass‐pollen and clinical manifestations of purely seasonal asthma in grass‐pollen pollination periods in Madrid (May to July) ? Patients with a CASI index of ? 6 points during the last grass‐pollen pollination peak (May‐June 2015)