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Not yet recruiting NCT07620522

Observational Study of RHINOSEDAL in Acute Nasal Obstruction

— Observational Nasal Obstruction Common Cold Allergic Rhinitis Non-allergic Rhinitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RHINOSEDAL.
Who it may be relevant to
Registry conditions: Nasal Obstruction, Common Cold, Allergic Rhinitis, Non-allergic Rhinitis. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • NOSE responder rate at Day 3 [Time frame: Day 3 evening]
Secondary outcome measures (8)
  • NOSE responder rate at Day 6 or end of study [Time frame: Day 6 ±1 day or early termination]
  • Daily evolution of total NOSE score [Time frame: Day 0 to Day 6 ±1 day or early termination]
  • Daily evolution of each NOSE questionnaire item [Time frame: Day 0 to Day 6 ±1 day or early termination]
  • Daily evolution of social activity impairment [Time frame: Day 0 to Day 6 ±1 day or early termination]
  • Patient global assessment of effectiveness [Time frame: End of study visit at Day 6 ±1 day or early termination]
  • Evolution of associated signs [Time frame: Day 0 to Day 6 ±1 day or early termination]
  • Adverse events, serious adverse events, incidents and device deficiencies [Time frame: Inclusion to Day 6 ±1 day or early termination]
  • Compliance / RHINOSEDAL use [Time frame: Day 0 to Day 6 ±1 day or early termination]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Multiples facilities — Multiple Locations

Identifiers

NCT: NCT07620522 · 2025-A02041-48

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗