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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02295969

Enrollment

307

Registered

2014-11-20

Start date

2014-12-31

Completion date

2017-07-03

Last updated

2017-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

Rhinitis, Conjunctivitis, Grass pollen, Sublingual tablet, Allergen immunotherapy, Safety

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.

Interventions

DRUGOralair

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 9 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026