Aetiological treatment of moderate-severe intermitent or persistent allergic rhinitis/rhinoconjunctivitis with or without controlled mild-moderate intermittent or persistent allergic asthma
Conditions
Brief summary
Overall symptom and medication score during the grass and olive tree pollen season (April, May, and June)
Detailed description
Symptom-free days, Medication-free days, Asthma exacerbations, Visual Analogue Scale (VAS), Immunological parameters: total IgE, specific IgE, specific IgG4, Asthma Control Questionnaire (ACQ-6), Rhinitis quality of life questionnaire (ESPRINT-15), Consumption of health resources, Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse event (AE) by administration and by subject; Assessment of administration site reactions, systemic reactions and any medication administered for the treatment of AE)
Interventions
DRUGMixture of modified allergen extracts of 6 grasses (MG01) and modified allergen extract of olive pollen (T517)
Sponsors
Inmunotek S.L.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall symptom and medication score during the grass and olive tree pollen season (April, May, and June) | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom-free days, Medication-free days, Asthma exacerbations, Visual Analogue Scale (VAS), Immunological parameters: total IgE, specific IgE, specific IgG4, Asthma Control Questionnaire (ACQ-6), Rhinitis quality of life questionnaire (ESPRINT-15), Consumption of health resources, Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse event (AE) by administration and by subject; Assessment of administration site reactions, systemic reactions and any medication administered for the treatment of AE) | — |
Countries
Spain
Outcome results
None listed