Phase 3
N=628
Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis
Allergy
Bottom Line
View on ClinicalTrials.gov: NCT00367640 ↗Enrolled (actual)
628
Serious AEs
0.6%
Results posted
May 2016
Primary outcome: Primary: Average Rhinoconjunctivitis Total Symptom Score — 4.72; 3.58; 3.74; 4.93 Units on a scale (range: 0 to 18) — p=0.0006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 100 IR grass pollen allergen extract tablet (Drug); 300 IR grass pollen allergen extract tablet (Drug); 500 IR grass pollen allergen extract tablet (Drug); Placebo tablet (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stallergenes Greer
- Primary completion
- Sep 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Rhinoconjunctivitis Total Symptom Score |
4.72; 3.58; 3.74; 4.93 | 0.0006 sig |
Summary
To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage
Eligibility Criteria
Inclusion Criteria
- Written consent
- Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
- Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
- Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
- Safety laboratory resuts within the references ranges
Exclusion Criteria
- Pregnancy, breast-feeding/lactation
- Had received desensitisation treatment for grass pollen
- Treatment by immunotherapy with another allergen within the previous 5 years
- Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
- Treated with beta-blockers or under continuous corticotherapy
Data sourced from ClinicalTrials.gov (NCT00367640). 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.