Phase 3
N=278
Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
Allergy
Bottom Line
View on ClinicalTrials.gov: NCT00409409 ↗Enrolled (actual)
278
Serious AEs
1.4%
Results posted
May 2016
Primary outcome: Primary: Average Rhinoconjunctivitis Total Symptom Score (ARTSS) — 3.25; 4.51 Units on a scale (range: 0 to 18) — p=0.0010
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 300 IR grass pollen allergen extract tablet (Drug); Placebo tablet (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Stallergenes Greer
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Rhinoconjunctivitis Total Symptom Score (ARTSS) |
3.25; 4.51 | 0.0010 sig |
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.
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). 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.