Observational Study of RHINOSEDAL in Acute Nasal Obstruction (RHINOSEDAL)

Prospective Multicenter Before-After Study in Children and Adults Treated for Acute Nasal Obstruction With RHINOSEDAL

This prospective, multicenter, national, observational, non-interventional post-market clinical follow-up study evaluates the performance and safety of RHINOSEDAL in children and adults presenting with acute nasal obstruction associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis. Patients prescribed RHINOSEDAL in routine care will be followed for 6 ±1 days using patient-reported outcome measures including the NOSE score.

Study Overview

• Status: Not yet recruiting
• Conditions: Allergic Rhinitis; Nasal Obstruction; Common Cold; Rhinosinusitis; Non-allergic Rhinitis
• Intervention / Treatment: Device: RHINOSEDAL

Detailed Description

RHINOSEDAL is a CE-marked class IIa medical device indicated in adults and children older than 2 years to relieve nasal congestion through an osmotic mechanism in cases of common cold, allergic or non-allergic rhinitis, and sinusitis. This prospective observational study is conducted in real-life conditions of use in French general practice. The decision to prescribe RHINOSEDAL is made before and independently from study participation. Patients aged 8 years and older with acute nasal obstruction evolving for less than 48 hours and baseline NOSE score >40/100 will be included. Patients will complete a self-assessment diary from Day 1 to Day 6 ±1. The primary endpoint is the proportion of patients achieving a decrease greater than 24 mm in the NOSE score between baseline Day 0 and the Day 3 evening assessment. Secondary endpoints include additional NOSE responder analyses, daily NOSE evolution, individual NOSE item evolution, social activity impairment, patient global assessment of effectiveness, associated signs, safety, device deficiencies, and compliance.

• Study Type: Observational
• Enrollment (Estimated): 126

Contacts and Locations

• Study Contact: Name: Renaud Urbinelli; Phone Number: +33756882093; Email: etudes@clin-experts.fr

Study Locations

• France
  • Multiple Locations, France
    • Multiples facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children and adults aged 8 years or older presenting with acute nasal obstruction associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis and treated in French general practice.

Description

Inclusion Criteria:

• Age 8 years or older.
• Acute nasal obstruction evolving for less than 48 hours associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis.
• Baseline NOSE score >40/100.
• No warning signs such as pus, unilateral obstruction, bleeding, or pain.
• RHINOSEDAL prescribed by the investigator.
• Written informed consent signed.
• Affiliated with a health insurance system.

Exclusion Criteria:

• Known anatomical cause of chronic nasal congestion.
• Corticosteroid use within the previous 2 days.
• NSAID use within the previous 2 days.
• Sympathomimetic use within the previous 2 days.
• Nasal decongestant or nasal irrigation within the previous 2 days.
• Antihistamines unless stable for more than 48 hours and maintained.
• Contraindication listed in the RHINOSEDAL instructions for use.
• Patient under legal protection.
• Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with RHINOSEDAL; Children and adults aged 8 years or older consulting a general practitioner for acute nasal obstruction associated with common cold, rhinitis, or rhinosinusitis and prescribed RHINOSEDAL in routine care.	Device: RHINOSEDAL; RHINOSEDAL is a ready-to-use hypertonic nasal spray containing natural sea water, tamarind extract and mallow extract. It acts mechanically through osmotic decongestion and cleansing of the upper airways. It is used according to the instructions for use and physician prescription.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NOSE responder rate at Day 3	Percentage of patients with a reduction greater than 24 mm in the NOSE (Nasal Obstruction Symptom Evaluation) score between baseline Day 0 and the Day 3 evening assessment. The NOSE questionnaire includes 5 items rated from 0 to 4 and normalized to a 0-100 score, where higher scores indicate more severe nasal obstruction symptoms. For this study, the recall period was adapted from one month to the previous 24 hours.	Day 3 evening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NOSE responder rate at Day 6 or end of study	Percentage of patients with a reduction greater than 24 mm in the NOSE score between baseline Day 0 and Day 6 ±1 day or early termination.	Day 6 ±1 day or early termination
Daily evolution of total NOSE score	Evolution of the total normalized NOSE score (0-100) assessed daily from inclusion through the patient diary until the final visit.	Day 0 to Day 6 ±1 day or early termination
Daily evolution of each NOSE questionnaire item	Daily evolution of the five individual NOSE questionnaire items assessing nasal congestion severity, nasal blockage, trouble breathing through the nose, trouble sleeping, and inability to get enough air during exertion. Each item is scored from 0 to 4.	Day 0 to Day 6 ±1 day or early termination
Daily evolution of social activity impairment	Evolution of the intensity of discomfort in social activities measured on a 5-point numerical scale from 0 to 4, where higher scores indicate greater impairment.	Day 0 to Day 6 ±1 day or early termination
Patient global assessment of effectiveness	Patient-rated overall effectiveness using a 5-point numerical scale: 0 = not effective at all; 1 = very slightly effective; 2 = slightly effective; 3 = fairly effective; 4 = very effective.	End of study visit at Day 6 ±1 day or early termination
Evolution of associated signs	Change in associated clinical signs including nasal discharge, sneezing, fever, and other symptoms associated with upper respiratory tract conditions.	Day 0 to Day 6 ±1 day or early termination
Adverse events, serious adverse events, incidents and device deficiencies	Number and description of adverse events, serious adverse events, incidents and device deficiencies reported during the study.	Inclusion to Day 6 ±1 day or early termination
Compliance / RHINOSEDAL use	Compliance assessed using the patient diary, including number of daily instillations of RHINOSEDAL.	Day 0 to Day 6 ±1 day or early termination

Collaborators and Investigators

• Sponsor: Laboratoires Elerte
• Collaborators: Clin-Experts
• Investigators: Principal Investigator: Pascal DEMOLY, MD, PhD, University hospital of Montpellier, FRANCE

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: medical device; nasal obstruction; rhinitis; rhinosinusitis; common cold; PMCF; nasal congestion; saline irrigation; real-world evidence; NOSE score
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Picornaviridae Infections; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Sinusitis; Paranasal Sinus Diseases; Airway Obstruction; Rhinosinusitis; Rhinitis; Common Cold; Rhinitis, Allergic; Nasal Obstruction
• Other Study ID Numbers: 2025-A02041-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No