Phase 3
Completed N=1,458
House Dust Mite Allergy Trial In Children
Allergic Rhinitis Due to Dermatophagoides Farinae · Allergic Rhinitis Due to Dermatophagoides Pteronyssinus · Allergic Rhinitis Due to House Dust Mite
Source: ClinicalTrials.gov NCT04145219 ↗
Enrolled (actual)
1,458
Serious AEs
1.5%
Results posted
Jun 2024
Primary outcomePrimary: Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period — 3.4; 4.4 score on a scale — p=<0.0001
◆ Published Evidence
Established
22citations · ~4 / year
Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations?
Summary
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)
Linked Publications (2)
-
Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations?
-
Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period |
3.4; 4.4 | <0.0001 sig |
| SECONDARY The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period |
1.5; 1.9 | <0.0001 sig |
| SECONDARY The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period |
1.4; 1.9 | 0.0016 sig |
| SECONDARY The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period |
4.0; 5.2 | <0.0001 sig |
| SECONDARY The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period |
1.7; 2.2 | <0.0001 sig |
| SECONDARY The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period |
1.8; 2.4 | 0.0018 sig |
| SECONDARY Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial |
0.8; 1.0 | <0.0001 sig |
| SECONDARY The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period |
0.3; 0.4 | 0.0259 sig |
| SECONDARY SABA Free Days During the Primary Efficacy Assessment Period |
99.2; 98.6 | 0.0527 |
| SECONDARY Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period |
1.0; 1.5 | 0.1256 |
| SECONDARY Rhinitis Mild Days During the Primary Efficacy Assessment Period |
31.8; 20.9 | 0.0008 sig |
| SECONDARY Rhinitis Exacerbation Days During the Primary Efficacy Assessment Period |
2.5; 4.4 | <0.0001 sig |
| SECONDARY Average Rhinitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period |
0.8; 1.0 | <0.0001 sig |
| SECONDARY Average Rhinoconjunctivitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period |
0.7; 0.9 | <0.0001 sig |
| SECONDARY House Dust Mite Specific IgE |
0.2; 0.0; 0.3; 0.0 | — |
| SECONDARY House Dust Mite Specific IgG4 |
0.6; 0.0; 0.7; 0.0 | — |
| SECONDARY Total IgE |
0.2; 0.0 | — |
| SECONDARY House Dust Mite IgE-Blocking Factor |
0.4; -0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects aged 5-11 years
- A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
- Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period
- Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
- Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D. farinae at screening
- Lung function ≥ 70% of predicted value
Exclusion Criteria
- Sensitised and regularly exposed to perennial allergens
- Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
- Asthma requiring treatment with high dose of inhaled corticosteroid
- A relevant history of systemic allergic reaction
Data sourced from ClinicalTrials.gov (NCT04145219) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.