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

NCT00367640 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 628

Last updated 2016-05-23

Study results available
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Summary

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

Conditions

  • Allergy

Interventions

DRUG

100 IR grass pollen allergen extract tablet

One sublingual tablet daily during 4 months before pollen season and during pollen season

DRUG

300 IR grass pollen allergen extract tablet

One sublingual tablet daily during 4 months before pollen season and during pollen season

DRUG

500 IR grass pollen allergen extract tablet

One sublingual tablet daily during 4 months before pollen season and during pollen season

DRUG

Placebo tablet

One sublingual tablet daily during 4 months before pollen season and during pollen season

Sponsors & Collaborators

  • Stallergenes Greer

    lead INDUSTRY

Principal Investigators

  • Alain DIDIER, Professor · Hôpital Rangueil-Larrey, Toulouse, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-09-30
Completion
2005-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00367640 on ClinicalTrials.gov