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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
RHINOSEDAL
DeviceRHINOSEDAL 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.
Treatment groups
126 Participants
are divided into 1 treatment groupGroup A: Patients treated with RHINOSEDAL1 intervention
Trial outcomes
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.
Time frame
Day 3 eveningSecondary outcomes
1
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.
Time frame
Day 6 ±1 day or early termination2
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.
Time frame
Day 0 to Day 6 ±1 day or early termination3
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.
Time frame
Day 0 to Day 6 ±1 day or early termination4
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.
Time frame
Day 0 to Day 6 ±1 day or early terminationLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Multiples facilities Status unavailable Multiple Locations
France
FranceSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laboratoires Elerte
Lead sponsor
Clin-Experts
Collaborator
Source ClinicalTrials.gov
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