Birch Pollen-induced Allergic Rhinoconjunctivitis
Conditions
Brief summary
The primary efficacy endpoint will be the average ARC TCS (TCS0-38) over the entire BPS2.
Detailed description
The average CSMS (CSMS0-6) over the entire BPS2., The average ARC DSS (DSS0-18) over the entire BPS2., The average ARC DMS (DMS0-20) over the entire BPS2, The rhinoconjunctivitis-associated functional problems as measured with the RQLQ(S) average overall score for adolescents aged between 12 to 17 years over the entire BPS2., The rhinoconjunctivitis-associated functional problems as measured with the PRQLQ average overall score for children between 6 to 11 years over the entire BPS2. Please refer to Section 10 of the Protocol for a full description of the assessments of efficacy.
Interventions
DRUGPlacebo - Staloral birch
DRUGoromucosal solution
DRUGSTALORAL Birke 10 IR/ml und 300 IR/ml
DRUGLösung zur Anwendung in der Mundhöhle
DRUGSTALORAL Birke 300 IR/ml
Sponsors
Stallergenes
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be the average ARC TCS (TCS0-38) over the entire BPS2. | — |
Secondary
| Measure | Time frame |
|---|---|
| The average CSMS (CSMS0-6) over the entire BPS2., The average ARC DSS (DSS0-18) over the entire BPS2., The average ARC DMS (DMS0-20) over the entire BPS2, The rhinoconjunctivitis-associated functional problems as measured with the RQLQ(S) average overall score for adolescents aged between 12 to 17 years over the entire BPS2., The rhinoconjunctivitis-associated functional problems as measured with the PRQLQ average overall score for children between 6 to 11 years over the entire BPS2. Please refer to Section 10 of the Protocol for a full description of the assessments of efficacy. | — |
Countries
Austria, Bulgaria, Finland, France, Germany, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, Sweden
Outcome results
None listed