Aetiological treatment of moderate to severe rhinitis/rhinoconjunctivitis with or without mild to moderate controlled allergic asthma
Conditions
Brief summary
The mean of the daily Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) during the Main Evaluation Period (the last 4 week of IMP treatment) by means of the Participant’s Diary
Detailed description
Rhinitis/Rhinoconjunctivitis Symptom Score (RSS), Rhinitis/Rhinoconjunctivitis Medication Score (RMS)., Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ACSMS)., Asthma Symptom Score (ASS), Asthma Medication Score (AMS), Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS), Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS), Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS), Asthma exacerbations: Time to first exacerbation; number, duration, and severity of exacerbations, Immunological parameters in blood samples: - Total IgE - Specific IgE for D. pteronyssinus and D. farinae - Specific IgE for D. pteronyssinus and D. farinae /Total IgE ratio, Allergen profiling (ALEX technique), if serum is available, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Participant and investigator health status perception through a Visual Analogue Scale (VAS), Consumption of health resources., Safety parameters: - Overall rate and severity of adverse events (AE) per administration and per participant. - Evaluation of reactions at the site of administration, systemic reactions and of any medication administered for the treatment of the AE
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean of the daily Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) during the Main Evaluation Period (the last 4 week of IMP treatment) by means of the Participant’s Diary | — |
Secondary
| Measure | Time frame |
|---|---|
| Rhinitis/Rhinoconjunctivitis Symptom Score (RSS), Rhinitis/Rhinoconjunctivitis Medication Score (RMS)., Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ACSMS)., Asthma Symptom Score (ASS), Asthma Medication Score (AMS), Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS), Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS), Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS), Asthma exacerbations: Time to first exacerbation; number, duration, and severity of exacerbations, Immunological parameters in blood samples: - Total IgE - Specific IgE for D. pteronyssinus and D. farinae - Specific IgE for D. pteronyssinus and D. farinae /Total IgE ratio, Allergen profiling (ALEX technique), if serum is available, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Participant and investigator health status perception through a Visual Analogue Scale (VAS), Consumption of health resources., Safety paramete | — |
Countries
Portugal, Spain