Observational Study of RHINOSEDAL in Acute Nasal Obstruction

NCT07620522 | Not Yet Recruiting

• 1 other identifier: 2025-A02041-48
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasal Obstruction; Common Cold; Allergic Rhinitis; Non-allergic Rhinitis; Rhinosinusitis

Keywords

nasal obstruction; NOSE score; rhinitis; rhinosinusitis; common cold; nasal congestion; saline irrigation; medical device; PMCF; real-world evidence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• NOSE responder rate at Day 6 or end of study

  Day 6 ±1 day or early termination

• Daily evolution of total NOSE score

  Day 0 to Day 6 ±1 day or early termination

• Daily evolution of each NOSE questionnaire item

  Day 0 to Day 6 ±1 day or early termination

• Daily evolution of social activity impairment

  Day 0 to Day 6 ±1 day or early termination

• Patient global assessment of effectiveness

  End of study visit at Day 6 ±1 day or early termination

Study Arms (1)

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

Interventions

RHINOSEDAL DEVICE

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.

Patients treated with RHINOSEDAL

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clin-Experts: collaborator
• Laboratoires Elerte: lead

Study Sites (1)

Multiples facilities

Multiple Locations, France

Location

MeSH Terms

Conditions

Nasal Obstruction; Common Cold; Rhinitis, Allergic; Rhinosinusitis; Rhinitis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sinusitis; Paranasal Sinus Diseases

Study Officials

• Pascal DEMOLY, MD, PhD

  University hospital of Montpellier, FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renaud URBINELLI

CONTACT

+33756882093; etudes@clin-experts.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

FR (1)