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

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ClinicalTrials.gov Identifier: NCT02295969
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
Venn Life Sciences
Information provided by (Responsible Party):
Stallergenes Greer

Study Description
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Brief Summary:
Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment.

Condition or disease Intervention/treatment
Allergy Drug: Oralair

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.

Study Design
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Study Type : Observational
Actual Enrollment : 307 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : December 2014
Actual Primary Completion Date : July 3, 2017
Actual Study Completion Date : July 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Groups and Cohorts
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Intervention Details:
  • Drug: Oralair
    Observational study, Oralair is used as prescribed by the prescriber phycisian.

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients, children 5 to 9 years of age prescribed ORALAIR for the treatment of grass-pollen-induced allergic rhinitis with or without conjunctivitis.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295969


Locations
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Germany
Klinikum Augsburg, Klinik für Kinder und Jugendliche
Augsburg, Bavaria, Germany, 86156
Sponsors and Collaborators
Stallergenes Greer
Venn Life Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stallergenes Greer
ClinicalTrials.gov Identifier: NCT02295969    
Other Study ID Numbers: SL74.14
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Keywords provided by Stallergenes Greer:
Rhinitis
Conjunctivitis
Grass pollen
 Sublingual tablet
Allergen immunotherapy
Safety
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases