A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)
The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment. In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL). The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,460
For daily administration (1 tablet per day)
For daily administration (1 tablet per day)
Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period
The primary endpoint in the trial was the average daily total combined rhinitis symptoms and medication score (TCRS) during the primary efficacy assessment period. The average daily TCRS evaluates the treatment effect based on the reduction in daily rhinitis symptoms and medication score (on a scale of 0-24). Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 daily TCRS values, the primary endpoint is calculated as the average of those values.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period
The average rhinitis DSS evaluates the treatment effect based on the reduction in daily rhinitis symptom score (on a scale of 0-12). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis DSS values, the endpoint is calculated as the average of those values.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period
Average rhinitis DMS evaluates the treatment effect based on the reduction in daily rhinitis medication use (on a scale of 0-12). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis DMS values, the endpoint is calculated as the average of those values.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
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Allergy & Asthma Specialists Medical Group and Research Center
Huntington Beach, California, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, United States
Miami Clinical Research
Miami, Florida, United States
Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center
Pensacola, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
GCP, Global Clinical Professionals
St. Petersburg, Florida, United States
Aeroallergy Research Labs of Savannah, Inc.
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Deaconess Clinic Allergy
Evansville, Indiana, United States
...and 103 more locations
The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period
Average rhinoconjunctivitis TCS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 daily TCS values, the endpoint is calculated as the average of those values.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period
The average rhinoconjunctivitis DSS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptom score (on a scale of 0-18). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis DSS values, the endpoint is calculated as the average of those values.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period
Average rhinoconjunctivitis DMS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis medication use (on a scale of 0-20). Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis DMS values, the endpoint is calculated as the average of those values.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial
The overall PRQLQ score measures the effect of rhinoconjunctivitis on participant's quality of life on a scale of 0-6. Higher scores indicate worse rhinoconjunctivitis-related quality of life.
Time frame: Week leading up to visit 7 (at the end of the primary efficacy assessment period, after approximately 52-57 weeks of treatment)
The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period
The average asthma DSS evaluates the treatment effect based on the reduction in daily asthma symptom score (on a scale of 0-12). Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 asthma DSS values, the endpoint is calculated as the average of those values.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
SABA Free Days During the Primary Efficacy Assessment Period
The endpoint SABA free days evaluates the treatment effect based on the reduction in SABA use. The higher the proportion of SABA free days the higher the estimated probability of a participant having a day where they didn't use SABA.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period
Average weekly number of puffs of as-needed SABA use evaluates the treatment effect based on the reduction in the use of asthma reliever medication (SABA), and is calculated as 7 times the average of the daily number of puffs of as-needed SABA use. Higher values indicate more medication use.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Rhinitis Mild Days During the Primary Efficacy Assessment Period
The endpoint rhinitis mild days evaluates the treatment effect based on days when participants have no symptoms or mild symptoms and no medication use. The higher the proportion of rhinitis mild days the higher the estimated probability of a participant having a rhinitis mild day.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Rhinitis Exacerbation Days During the Primary Efficacy Assessment Period
The endpoint rhinitis exacerbation days evaluates the treatment effect based on days when participants have severe symptoms. The higher the proportion of rhinitis mild days the higher the estimated probability of a participant having a rhinitis exacerbation day.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Average Rhinitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period
Average rhinitis CSMS evaluates the treatment effect based on the reduction in daily rhinitis symptoms and/or medication use. For this endpoint, the rhinitis symptoms and medication use were scored using an alternative method as recommended by EAACI (European Academy of Allergy \& Clinical Immunology) (on a scale of 0-5). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinitis CSMS values, the endpoint is calculated as the average of those values.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
Average Rhinoconjunctivitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period
Average rhinoconjunctivitis CSMS evaluates the treatment effect based on the reduction in daily rhinoconjunctivitis symptoms and/or medication use. For this endpoint, the rhinoconjunctivitis symptoms and medication use were scored using an alternative method as recommended by EAACI (European Academy of Allergy \& Clinical Immunology) (on a scale of 0-5). Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 8-week primary efficacy assessment period. For example, if a subject reported 56 rhinoconjunctivitis CSMS values, the endpoint is calculated as the average of those values.
Time frame: 8 weeks (primary efficacy assessment period), which started 44-49 weeks after initiation of IMP
House Dust Mite Specific IgE
House dust mite specific IgE reflects the allergen-specific allergy immunotherapy-induced immune modulation
Time frame: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
House Dust Mite Specific IgG4
House dust mite specific IgG4 reflects the allergen-specific allergy immunotherapy-induced immune modulation
Time frame: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
Total IgE
The change in total IgE was measured from screening to the end of trial.
Time frame: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)
House Dust Mite IgE-Blocking Factor
The IgE-blocking factor assesses the effect of serum components (including IgE-blocing antibodies known to be induced by allergy immunotherapy) competing with IgE for binding to allergen. IgE-blocking factor is calculated as 1-(S/T), where S is the amount of allergen-specific IgE bound to allergen in the (possible) presence of competing components, and where T is the total amount of allergen-specific IgE capable of binding to allergen when all competing antibodies/components have been washed off. IgE-blocking factor values closer to 0 indicate the presence of fewer IgE-blocking components and values closer to 1 indicate that more IgE is blocked from binding to the allergen.
Time frame: Change from screening to the end of trial (after approximately 52-57 weeks of treatment)