Observational Study of Allergic Rhinitis in Children | NCT05655858

Studies
Observational Study of Allergic Rhinitis in Children

NCT05655858

Sponsor

ALK-Abelló A/S

Status

Completed

Last Update Posted

Oct 3, 2025Actual

Enrollment

1,004Actual

Phase

Not provided

Conditions

Allergic Rhinitis

Interventions

Management of allergic rhinitis

Countries

France

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

Sep 2025

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

Nov 23, 2022Actual

Primary Completion Date

Mar 3, 2024Actual

Completion Date

Mar 3, 2024Actual

First Submitted Date

Dec 1, 2022

First Submission Date that Met QC Criteria

Dec 9, 2022

First Posted Date

Dec 19, 2022Actual

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

Sep 30, 2025

Last Update Posted Date

Oct 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Observational, cross-sectional, prospective, multicentric study in France with private paediatricians to describe the management of allergic rhinitis in children.

Detailed Description

Data collected about diagnostic, comorbidities, clinical history, management of allergic rhinitis using a patient paper case report form. There is only one visit per patient and investigators can include up to 20 patients.

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

1,004Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Management of allergic rhinitis	Other	Collection of patient data in real-life

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of children over 2 years of age with allergic rhinitis eligible for allergic immunotherapy	Descriptive analysis : evaluation with data collected in the case report form about allergic rhinitis	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Under 18 years of age
With allergic rhinitis
Who's representative of the parental authority did not object to his child's participation after oral and written information and who agrees to participate

Exclusion Criteria:

Child or adolescent opposed to participate or collect his personal data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

1000 patients aged 2 to 18 years old with allergic rhinitis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Necker-Enfants malades - AP-HP Service de Pneumologie et Allergologie Pédiatriques		Paris		75015	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided