Nasal ObstructionRHINOSEDALNCT07620522
Observational Study of RHINOSEDAL in Acute Nasal Obstruction
An observational study of Nasal Obstruction and Common Cold, run by Laboratoires Elerte at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Nasal Obstruction, Common Cold, Allergic Rhinitis
- What is being tested?
- RHINOSEDAL
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Contraindication listed in the RHINOSEDAL instructions for use.
- Patient under legal protection.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- RHINOSEDAL
- Keywords
- nasal obstruction, NOSE score, rhinitis, rhinosinusitis, common cold, nasal congestion, saline irrigation, medical device, PMCF, real-world evidence
- Medical subject headings
- Nasal Obstruction, Common Cold, Rhinitis, Allergic, Rhinosinusitis, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHINOSEDALDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RHINOSEDAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3 evening
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 to Day 6 ±1 day or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Elerte
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
- Investigators
- Pascal DEMOLY, MD, PhD, Principal investigator, University hospital of Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620522
- Sponsor's protocol ID
- 2025-A02041-48
- Acronym
- RHINOSEDAL
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Before-After Study in Children and Adults Treated for Acute Nasal Obstruction With RHINOSEDAL
- ClinicalTrials.gov ID
- NCT07620522
- Acronym / sponsor ID
- RHINOSEDAL / 2025-A02041-48
- Keywords
- nasal obstruction, NOSE score, rhinitis, rhinosinusitis, common cold, nasal congestion, saline irrigation, medical device
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Laboratoires ElerteIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with RHINOSEDAL | – | Device: RHINOSEDALChildren 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RHINOSEDALRHINOSEDAL 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. | Device | Patients treated with RHINOSEDAL |
Primary outcome
NOSE responder rate at Day 3
Time frame: 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.
8 secondary outcomes
NOSE responder rate at Day 6 or end of study
Time frame: Day 6 ±1 day or early termination
Daily evolution of total NOSE score
Time frame: Day 0 to Day 6 ±1 day or early termination
Daily evolution of each NOSE questionnaire item
Time frame: Day 0 to Day 6 ±1 day or early termination
Daily evolution of social activity impairment
Time frame: Day 0 to Day 6 ±1 day or early termination
Patient global assessment of effectiveness
Time frame: End of study visit at Day 6 ±1 day or early termination
Evolution of associated signs
Time frame: Day 0 to Day 6 ±1 day or early termination
Adverse events, serious adverse events, incidents and device deficiencies
Time frame: Inclusion to Day 6 ±1 day or early termination
Compliance / RHINOSEDAL use
Time frame: Day 0 to Day 6 ±1 day or early termination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pascal DEMOLY, MD, PhD principal investigator
University hospital of Montpellier, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Obstruction and Common Cold, run by Laboratoires Elerte at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renaud URBINELLI (+33756882093, etudes@clin-experts.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NOSE responder rate at Day 3 (time frame: Day 3 evening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.