Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Observational Study of RHINOSEDAL in Acute Nasal Obstruction (RHINOSEDAL)

27. maj 2026 opdateret af: Laboratoires Elerte

Prospective Multicenter Before-After Study in Children and Adults Treated for Acute Nasal Obstruction With RHINOSEDAL

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

126

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Multiple Locations, Frankrig
        • Multiples facilities

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients treated with RHINOSEDAL
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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
NOSE responder rate at Day 3
Tidsramme: 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.
Day 3 evening

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
NOSE responder rate at Day 6 or end of study
Tidsramme: 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.
Day 6 ±1 day or early termination
Daily evolution of total NOSE score
Tidsramme: 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.
Day 0 to Day 6 ±1 day or early termination
Daily evolution of each NOSE questionnaire item
Tidsramme: 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.
Day 0 to Day 6 ±1 day or early termination
Daily evolution of social activity impairment
Tidsramme: 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.
Day 0 to Day 6 ±1 day or early termination
Patient global assessment of effectiveness
Tidsramme: 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.
End of study visit at Day 6 ±1 day or early termination
Evolution of associated signs
Tidsramme: 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.
Day 0 to Day 6 ±1 day or early termination
Adverse events, serious adverse events, incidents and device deficiencies
Tidsramme: 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.
Inclusion to Day 6 ±1 day or early termination
Compliance / RHINOSEDAL use
Tidsramme: Day 0 to Day 6 ±1 day or early termination
Compliance assessed using the patient diary, including number of daily instillations of RHINOSEDAL.
Day 0 to Day 6 ±1 day or early termination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Laboratoires Elerte

Samarbejdspartnere

Clin-Experts

Efterforskere

  • Ledende efterforsker: Pascal DEMOLY, MD, PhD, University hospital of Montpellier, FRANCE

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. oktober 2026

Primær færdiggørelse (Anslået)

31. oktober 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-A02041-48

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Allergisk rhinitis

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Belarus

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner