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NCT02295969 Clinical Trial

Observational Study of Oralair® in Children 5-9 Years With Grass-pollen-induced Allergic Rhinitis With/Without Conjunctivitis

Allergy Clinical Trial

Official title:
An Observational Study of ORALAIR® (Grass Pollen Allergen Extract From: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) Tablet for Sublingual Use in Children 5 to 9 Years of Age With Grass-pollen-induced Allergic Rhinitis With or Without Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02295969
Other study ID # SL74.14
Secondary ID
Status Completed
Phase N/A
First received November 18, 2014
Last updated July 25, 2017
Start date December 2014
Est. completion date July 3, 2017

Study information
Verified date July 2017
Source Stallergenes Greer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment.

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 information / eligibility
Status Completed
Enrollment 307
Est. completion date July 3, 2017
Est. primary completion date July 3, 2017
Accepts healthy volunteers No
Gender All
Age group 5 Years to 9 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Oralair
Observational study, Oralair is used as prescribed by the prescriber phycisian.

Locations
Country Name City State
Germany Klinikum Augsburg, Klinik für Kinder und Jugendliche Augsburg Bavaria

Sponsors (2)
Lead Sponsor Collaborator
Stallergenes Greer Venn Life Sciences

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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