Implementation of an Allergic Rhinitis Severity Questionn... | NCT07315945

Studies
Implementation of an Allergic Rhinitis Severity Questionnaire in ENT Consultations

NCT07315945

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Jan 5, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Allergic Rhinitis

Interventions

Not provided

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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2025Actual

Primary Completion Date

Feb 2026Estimated

Completion Date

Feb 2026Estimated

First Submitted Date

Dec 18, 2025

First Submission Date that Met QC Criteria

Dec 18, 2025

First Posted Date

Jan 5, 2026Actual

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

Dec 18, 2025

Last Update Posted Date

Jan 5, 2026Actual

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

Allergic rhinitis is a very common condition (affecting 1 in 5 people in Europe) and a costly one for society (direct and indirect costs). Symptoms vary depending on the time of year, and treatments are primarily symptomatic, with follow-up in ENT consultations. Scientific societies (EAACI, FDA, EMA) recommend using a universal tool (severity score) (the CSMS score, SCST in French) to monitor severity and follow-up, and to obtain consistent data that can be extrapolated to other scientific data (meta-analyses).

Therefore, investigators in the ENT department use this SCST score (as well as others such as the SNOT 22 score) to assess the severity of allergic rhinitis in our patients and its progression.

Tbe investigators wish to confirm the acceptability of this tool for patients, and the statistical value of its properties.

Detailed Description

Not provided

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-Assessment Clinical Symptom Score (SCST)	Rating Scale Each symptom is rated by the patient according to its intensity: 0: absent 1: mild 2: moderate 3: severe Calculating the Score Add the scores for each symptom. The total SCST score reflects the overall severity of the symptoms: Low score → mild symptoms High score → severe symptoms Interpretation Before treatment: establish a baseline. After treatment: compare the scores to assess effectiveness. A decrease in the score indicates clinical improvement.	Up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (≥18 years)
Follow-up at the ENT department of Hautepierre University Hospital for allergic rhinitis

Exclusion Criteria:

Asymptomatic individuals not requiring follow-up consultations.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult (≥18 years) having follow-up at the ENT department of Hautepierre University Hospital for allergic rhinitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Léa FATH, MD	Contact	33 3 88 12 76 52		lea.fath@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

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