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Observational Study of RHINOSEDAL in Acute Nasal Obstruction

NCT07620522 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2026-06-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Clin-Experts

    collaborator INDUSTRY

  • Laboratoires Elerte

    lead INDUSTRY

Principal Investigators

  • Pascal DEMOLY, MD, PhD · University hospital of Montpellier, FRANCE

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-15
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • France

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620522 on ClinicalTrials.gov