Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture
Phase 3
Completed
- Conditions
- Grass Pollen Allergy
- Registration Number
- NCT00264459
- Lead Sponsor
- Allergopharma GmbH & Co. KG
- Brief Summary
The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Rhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,
Exclusion Criteria
Serious chronic diseases, Other perennial allergies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Symptom and Medication Score (SMS) 1.5 years of therapy The primary endpoint is the change of the area under the curve (AUC, derived from an analysis period of 42 days) of the daily sum of the Symptom and Medication Score (SMS) from the baseline measurement to the measurement after 1.5 years of therapy.
- Secondary Outcome Measures
Name Time Method Visual Rating Scale 1.5 years Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)
Trial Locations
- Locations (1)
Allergopharma GmbH & Co. KG
🇩🇪Reinbek, Germany
Allergopharma GmbH & Co. KG🇩🇪Reinbek, Germany