Observational Study of RHINOSEDAL in Acute Nasal Obstruction

N/ANot Yet RecruitingNCT07620522

Laboratoires Elerte126 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

126

Conditions

Nasal Obstruction Common Cold Allergic Rhinitis

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.