Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis
This study has been completed.
Information provided by:
First received: August 22, 2006
Last updated: October 8, 2009
Last verified: October 2009
To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage
Biological: Sublingual immunotherapy tablets - grass pollen
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
Further study details as provided by Stallergenes:
Primary Outcome Measures:
- • To assess the efficacy of SLIT on the Rhinoconjunctivitis Total Symptom Score (RTSS)
Secondary Outcome Measures:
- Rescue medication usage.
- 6individual symptom scores of the Rhinoconjunctivitis Symptom Score (RSS).
- Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score.
- Global evaluation by the patient.
- To document the safety of the treatment
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||August 2005|
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