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

NCT ID: NCT02295969

Last Updated: 2017-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

307 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-07-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Allergy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Oralair

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Venn Life Sciences

OTHER

Sponsor Role collaborator

Stallergenes Greer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinikum Augsburg, Klinik für Kinder und Jugendliche

Augsburg, Bavaria, Germany

Site Status

Countries

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Germany

References

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Gerstlauer M, Szepfalusi Z, Golden D, Geng B, de Blic J. Real-life safety of 5-grass pollen tablet in 5-to-9-year-old children with allergic rhinoconjunctivitis. Ann Allergy Asthma Immunol. 2019 Jul;123(1):70-80. doi: 10.1016/j.anai.2019.04.011. Epub 2019 Apr 19.

Reference Type DERIVED
PMID: 31009701 (View on PubMed)

Other Identifiers

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SL74.14

Identifier Type: -

Identifier Source: org_study_id

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