Phase 3
N=381
Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Primary Disease
Bottom Line
View on ClinicalTrials.gov: NCT00803244 ↗Enrolled (actual)
381
Serious AEs
0.5%
Results posted
May 2016
Primary outcome: Primary: Average Adjusted Symptom Score (AAdSS) — 5.58; 6.07 Units on a scale (range: 0 to 18) — p=0.2344
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 300 IR (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Stallergenes Greer
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Adjusted Symptom Score (AAdSS) |
5.58; 6.07 | 0.2344 |
Summary
The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.
Eligibility Criteria
Inclusion criteria
- Male or female outpatients aged 12 to 65 years (inclusive).
- Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
- Positive SPT
- RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.
Exclusion Criteria
- Positive SPT to any other seasonal allergens present during the grass pollen season
- Patients with clinically significant confounding symptoms of allergy to other allergens
- Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
- Patients with moderate or severe persistent asthma (Global Initiative for Asthma [GINA] 3 or 4).
Data sourced from ClinicalTrials.gov (NCT00803244). 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.