Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Stallergenes Greer
- Enrollment
- 628
- Primary Endpoint
- Average Rhinoconjunctivitis Total Symptom Score
Study Overview
Brief Summary
To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
100 IR
100 IR grass pollen allergen extract tablet
Intervention: 100 IR grass pollen allergen extract tablet (Drug)
300 IR
300 IR grass pollen allergen extract tablet
Intervention: 300 IR grass pollen allergen extract tablet (Drug)
500 IR
500 IR grass pollen allergen extract tablet
Intervention: 500 IR grass pollen allergen extract tablet (Drug)
Placebo
Placebo tablet
Intervention: Placebo tablet (Drug)
Outcomes
Primary Outcomes
Average Rhinoconjunctivitis Total Symptom Score
Time Frame: Pollen period (average of 32 days in the ITT set)
Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome.
Secondary Outcomes
No secondary outcomes reported