Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

Phase 2

Completed

• Conditions: Allergy
• Interventions: Drug: 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

• Registration Number: NCT00367640
• Lead Sponsor: Stallergenes Greer

Brief Summary

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2006-08-22
• Study First Submitted QC: 2006-08-22
• Study First Posted: 2006-08-23
• Results First Submitted: 2016-01-25
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Results First Posted: 2016-05-23
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 628

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100 IR	100 IR grass pollen allergen extract tablet	100 IR grass pollen allergen extract tablet
300 IR	300 IR grass pollen allergen extract tablet	300 IR grass pollen allergen extract tablet
500 IR	500 IR grass pollen allergen extract tablet	500 IR grass pollen allergen extract tablet
Placebo	Placebo tablet	Placebo tablet

Primary Outcome Measures

Name	Time	Method
Average Rhinoconjunctivitis Total Symptom Score	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.