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

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

Completed

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Key information

Conditions

Allergy Conjunctival Diseases Conjunctivitis Eye Diseases Hypersensitivity Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Augsburg, Klinik für Kinder und Jugendliche

Augsburg, Bavaria, 86156, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oralair

Drug

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

Primary outcomes

All adverse events that started on or after the day the first dose of Oralair

Time frame: During 30 days after the date of the first dose

Sponsors and collaborators

Lead sponsor

Stallergenes Greer

Industry

Collaborators

Venn Life Sciences

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Nov 20, 2014
Registry last updated: Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed