Observational Study of Oralair® in Children 5-9 Years With Grass-pollen-induced Allergic Rhinitis With/Without Conjunctivitis
Completed
- Conditions
- Allergy
- Registration Number
- NCT02295969
- Lead Sponsor
- Stallergenes Greer
- Brief Summary
Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment.
- Detailed Description
The purpose of this study is to further describe the safety and tolerability of ORALAIR tablets in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or without conjunctivitis.
Patients are followed for safety and tolerability during the first 30 treatment days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 307
Inclusion Criteria
Allergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive) prescribed ORALAIR.
Exclusion Criteria
Patients already participating in a clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All adverse events that started on or after the day the first dose of Oralair During 30 days after the date of the first dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Klinikum Augsburg, Klinik für Kinder und Jugendliche
🇩🇪Augsburg, Bavaria, Germany