Phase 3
N=633
Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets
Allergy
Bottom Line
View on ClinicalTrials.gov: NCT00418379 ↗Enrolled (actual)
633
Serious AEs
3.5%
Results posted
May 2016
Primary outcome: Primary: Average Adjusted Symptom Score (AAdSS) — 3.39; 3.25; 5.21 Units on a scale (range: 0 to 18) — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 300 IR (4M) (Drug); 300 IR (2M) (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stallergenes Greer
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Adjusted Symptom Score (AAdSS) |
3.39; 3.25; 5.21 | < 0.0001 sig |
Summary
A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients aged 18 to 50 years
- Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons
- Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens
- A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)
Exclusion Criteria
- Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included.
- Asthma requiring treatment other than beta-2 inhaled agonists.
- Patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years.
Data sourced from ClinicalTrials.gov (NCT00418379). 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.