Observational Study of Oralair® in Children 5-9 Years Wit... | NCT02295969

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

NCT02295969

Sponsor

Stallergenes Greer

Status

Completed

Last Update Posted

Jul 26, 2017Actual

Enrollment

307Actual

Phase

Not provided

Conditions

Allergy

Interventions

Oralair

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Jul 3, 2017Actual

Completion Date

Jul 3, 2017Actual

First Submitted Date

Nov 18, 2014

First Submission Date that Met QC Criteria

Nov 18, 2014

First Posted Date

Nov 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2017

Last Update Posted Date

Jul 26, 2017Actual

Name	Class
Venn Life Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

307Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oralair	Drug	Observational study, Oralair is used as prescribed by the prescriber phycisian.

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

9 Years

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Augsburg, Klinik für Kinder und Jugendliche		Augsburg	Bavaria	86156	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31009701	Derived	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.

ID	Term
D006967	Hypersensitivity
D012220	Rhinitis
D003231	Conjunctivitis

ID	Term
D007154	Immune System Diseases
D012141	Respiratory Tract Infections
D007239	Infections
D009668	Nose Diseases