An observational study in Nasal Obstruction, Common Cold and Allergic Rhinitis, sponsored by Laboratoires Elerte. Not yet recruiting at 1 site in France. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Laboratoires Elerte · Observational
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.
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.
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.
Exclusion Criteria:
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
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.
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 evening
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 termination
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 termination
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 termination
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 termination
Patient global assessment of effectiveness
Patient-rated overall effectiveness using a 5-point numerical scale: 0 = not effective at all; 1 = very slightly effective; 2 = slightly effective; 3 = fairly effective; 4 = very effective.
Time frame: End of study visit at Day 6 ±1 day or early termination
Evolution of associated signs
Change in associated clinical signs including nasal discharge, sneezing, fever, and other symptoms associated with upper respiratory tract conditions.
Time frame: Day 0 to Day 6 ±1 day or early termination
Adverse events, serious adverse events, incidents and device deficiencies
Number and description of adverse events, serious adverse events, incidents and device deficiencies reported during the study.
Time frame: Inclusion to Day 6 ±1 day or early termination
Compliance / RHINOSEDAL use
Compliance assessed using the patient diary, including number of daily instillations of RHINOSEDAL.
Time frame: Day 0 to Day 6 ±1 day or early termination
Plan to share: Undecided
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Laboratoires Elerte