Phase 3
Completed N=278
Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
Source: ClinicalTrials.gov NCT00409409 ↗Enrolled (actual)
278
Serious AEs
1.4%
Results posted
May 2016
Primary outcomePrimary: Average Rhinoconjunctivitis Total Symptom Score (ARTSS) — 3.25; 4.51 Units on a scale (range: 0 to 18) — p=0.0010
◆ Published Evidence
Highly cited
329citations · ~19 / year
Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis.
Summary
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.
Linked Publications
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Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Rhinoconjunctivitis Total Symptom Score (ARTSS) |
3.25; 4.51 | 0.0010 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients aged 5 to 17 years.
- Written consent / assent.
- Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
- Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
- Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.
Exclusion Criteria
- Patients who have received any desensitisation treatment for grass pollen.
Data sourced from ClinicalTrials.gov (NCT00409409) 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.