Observational Study of RHINOSEDAL in Acute Nasal Obstruction
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8+
SponsorLaboratoires Elerte
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RHINOSEDAL
Treatment groups
126 Participants
are divided into 1 treatment groupLocations
1Multiples facilities Multiple Locations France
Sponsors and collaborators
Laboratoires Elerte
Lead sponsor
Clin-Experts
Collaborator
Source ClinicalTrials.gov