Allergic Rhinitis, Common Cold, Nasal Obstruction, Non-allergic Rhinitis, Rhinosinusitis
Conditions
Keywords
nasal obstruction, NOSE score, rhinitis, rhinosinusitis, common cold, nasal congestion, saline irrigation, medical device, PMCF, real-world evidence
Brief 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.
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
DEVICERHINOSEDAL
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
Laboratoires Elerte
Clin-Experts
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NOSE responder rate at Day 3 | Day 3 evening | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NOSE responder rate at Day 6 or end of study | Day 6 ±1 day or early termination | 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. |
| Daily evolution of total NOSE score | Day 0 to Day 6 ±1 day or early termination | Evolution of the total normalized NOSE score (0-100) assessed daily from inclusion through the patient diary until the final visit. |
| Daily evolution of each NOSE questionnaire item | Day 0 to Day 6 ±1 day or early termination | 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. |
| Daily evolution of social activity impairment | Day 0 to Day 6 ±1 day or early termination | 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. |
| Patient global assessment of effectiveness | End of study visit at Day 6 ±1 day or early termination | 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. |
| Evolution of associated signs | Day 0 to Day 6 ±1 day or early termination | Change in associated clinical signs including nasal discharge, sneezing, fever, and other symptoms associated with upper respiratory tract conditions. |
| Adverse events, serious adverse events, incidents and device deficiencies | Inclusion to Day 6 ±1 day or early termination | Number and description of adverse events, serious adverse events, incidents and device deficiencies reported during the study. |
| Compliance / RHINOSEDAL use | Day 0 to Day 6 ±1 day or early termination | Compliance assessed using the patient diary, including number of daily instillations of RHINOSEDAL. |
Countries
France
Contacts
CONTACTRenaud URBINELLI
PRINCIPAL_INVESTIGATORPascal DEMOLY, MD, PhD
University hospital of Montpellier, FRANCE
Outcome results
None listed