Prospective, randomised, double-blind, placebo-controlled multicenter clinical trial to evaluate efficacy and safety of sublingual immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae_MM09-SLG-058
Phase 3 – large-scale trial before approval
Conditions:
Aetiological treatment of moderate to severe rhinitis/rhinoconjunctivitis with or without mild to moderate controlled allergic asthma
Sponsor: Inmunotek S.L.
trial.available_in:
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Overview
Trial status: Authorised
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
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
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
Who can participate
Age group: 18-64 years, 65+ years, 0-17 years
Gender: Female, Male
Target enrollment: 147 participants
Interventions
The IMP placebo is a solution identical in composition to the active treatment, but without active ingredients.
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