Clinical trial to evaluate the efficacy and safety of Depigoid DUO Grass-Mix/Olea (1000 DPP/mL + 1000 DPP/mL) compared with placebo in patients suffering from allergic rhinoconjunctivitis with or without asthma due to clinically relevant sensitisation to grass and olive pollen.

Condition studied

Allergic rhinoconjunctivitis with or without asthma due to clinically relevant sensitisation to grass and olive pollen.

Investigational medicinal product(s)

Eligibility

Primary endpoint

Mean cSMS (0-6) at peak grass and olive pollen season comparing active and placebo groups after at least 8 injections of treatment. - Medication score: 0 no medication, 0.5 antihistamine eye drops, 1 oral antihistamine, 1.5 intranasal corticoid - Symptom score: 0 none, 1 mild, 2 moderate, 3 severe: runny nose, sneezing, itchy nose, nasal congestion, itchy eyes, and tearing

Endpoint detail

Absolute values and changes from baseline (if applicable) during active pollen season comparing active and placebo groups after at least 8 injections: -Mean cSMS during the whole grass and olive pollen season -Asthma symptoms and asthma medication score -Severity of rhinoconjunctivitis (ARIA) and asthma (GINA) -QoL (RQLQ/pRQLQ/ AdolRQLQ, AQLQ/PAQLQ)-ESPIA-VAS-ACT..Please refer to the Protocol for further details, In the subset of participants with asthma, during the pollen peak and throughout the pollen season:-Lung function measured by FEV1 when possible-Quality of life measured by the AQLQ for adults or the paediatric version (PAQLQ)-Asthma control measured by the ACT for adults or the paediatric version (pACT)-Asthma severity as classified by the GINA guidelines -Asthma exacerbations (Number,severity, and duration), Total and specific IgE and IgG4 (through InmunoCAP) to Grass-Mix and Phleum pratense, Phl p1, Phl p5, and Olea europaea, Olee1, Total IgA2