Status:
COMPLETED
Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Lead Sponsor:
Stallergenes Greer
Conditions:
Primary Disease
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for...
Detailed Description
To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on: \- The Average Adjusted Symptom Score (AASS). To document the...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female outpatients aged 12 to 65 years (inclusive).
- Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
- Positive SPT
- RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.
- Exclusion Criteria:
- Positive SPT to any other seasonal allergens present during the grass pollen season
- Patients with clinically significant confounding symptoms of allergy to other allergens
- Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
- Patients with moderate or severe persistent asthma (Global Initiative for Asthma \[GINA\] 3 or 4).
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT00803244
Start Date
January 1 2009
End Date
January 1 2010
Last Update
May 25 2016
Active Locations (6)
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1
Stallergenes Sa
Antony, France, 92183
2
Hop Montauban
Montauban, France
3
Cab medical
Orange, France
4
Azienda Ospedaliera
Parma, Italy