RhinitisDEFINCT04230993
Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
A study testing Sea water solution in people with Rhinitis, run by YSLab at 1 site in France.
Trial summary
The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Rhinitis
- What is being tested?
- Sea water solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 24 Dec 2019to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Person with an upper respiratory condition (cold, rhinitis, nasopharyngitis ...) with symptoms of nasal congestion and intense runny nose moderate to severe (Jackson derived score ≥ 4)
- Ability of the patient (for adults) or their legal representative (for children) to follow the guidelines of the medical device
- have given their written informed consent
Who cannot join
- Patient with no cold symptoms, including no nasal congestion (chronic dry rhinitis…)
- Patient under treatment with cortisone derivative, mucolytic, or medication containing pseudoephedrine or related product acting on nasal congestion or having used such a product in the 3 days before inclusion
- Patient who used a nasal wash product in the 3 days before inclusion
- Patient allergic to seafood, or to any of the components of the products under study
- Vulnerable patient whose inclusion is not justified by the research objectives: woman pregnant, parturient, psychiatric patient, or adult subject to legal protection
- Patient participating or having participated in any other clinical study in the 30 days before the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.
Read the detailed description
The main endpoint is a symptom score derived from the Jackson scale: sum of 2 items relating to runny nose and nasal congestion (stuffy nose), with ratings of 0 to 3 for each (0: absent ; 1: mild; 2: moderate; 3: severe).
- Conditions
- Rhinitis
- Being tested
- Sea water solution
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sea water solutionOther
Administration of different sea water solution is performed and the rating of cold symptoms according to the Jackson scale, the fluidity of mucus and the ease of blowing will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Ocean Bio Actif-Fluid+ | Experimental | Moderate hypertonic seawater solution (15 g / L NaCl) with polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products. Receives: Other: Sea water solution |
| Ocean Bio Active-Stuffy nose | Experimental | Moderate hypertonic seawater solution (15 g / L NaCl) without polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products. Receives: Other: Sea water solution |
| Ocean Bio Active-Hygiene of the nose | Active comparator | Isotonic seawater solution (9 g / L NaCl). The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products. Receives: Other: Sea water solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of nasal washing with a hypertonic seawater solution Nose hygiene).
Effect of nasal washing with a hypertonic seawater solution (Ocean Bio Actif-Fluid + or Ocean Bio Actif-Stuffy nose) on runny nose and nasal congestion during treatment after 3 days of use, compared to an isotonic solution (Ocean Bio Actif- Nose hygiene). symptom score (runny nose and nasal congestion) derived from the Jackson scale with a score of 0 to 3 for each (0: absent; 1: mild; 2: moderate; 3: severe) between Day 0 and Day 3.
Measured: 3 days
Secondary outcomes (8)
Symptom score
The effect of nasal wash on the evolution of symptoms over time
Measured: 7 days
Presence or absence of fluid mucus
The effect of nasal wash on the evolution of the mucus fluidification over time
Measured: 7 days
Global Clinical Impression Scale
Global Clinical Impression of the investigator on the evolution of symptoms
Measured: between day 3 and day 7
Global Patient Impression Scale
Global Impression of the patient on the evolution of symptoms
Measured: between day 3 and day 7
Use of medical device
Number of daily sprays
Measured: 7 days
Safety of medical device
Number of adverse events
Measured: 7 days
Likert scale
Satisfaction of patient for the medical device
Measured: 7 days
Number of concomitant treatment
concomitant administration of treatments related to rhinitis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start24 Dec 2019
- Primary completion20 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- YSLab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain BOYE, MD, Principal investigator, Coordinator of the study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230993
- Sponsor's protocol ID
- 2019-A01705-52
- Acronym
- DEFI
- Status last verified
- Jul 2020
- First submitted
- 3 Jan 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
- ClinicalTrials.gov ID
- NCT04230993
- Acronym / sponsor ID
- DEFI / 2019-A01705-52
- Conditions
- Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- YSLabIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 18 Jan 2020 (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.
The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.
Detailed description
The main endpoint is a symptom score derived from the Jackson scale: sum of 2 items relating to runny nose and nasal congestion (stuffy nose), with ratings of 0 to 3 for each (0: absent ; 1: mild; 2: moderate; 3: severe).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ocean Bio Actif-Fluid+ | Experimental | Other: Sea water solutionModerate hypertonic seawater solution (15 g / L NaCl) with polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products. |
| Ocean Bio Active-Stuffy nose | Experimental | Other: Sea water solutionModerate hypertonic seawater solution (15 g / L NaCl) without polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products. |
| Ocean Bio Active-Hygiene of the nose | Active comparator | Other: Sea water solutionIsotonic seawater solution (9 g / L NaCl). The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Person with an upper respiratory condition (cold, rhinitis, nasopharyngitis ...) with symptoms of nasal congestion and intense runny nose moderate to severe (Jackson derived score ≥ 4)
- Ability of the patient (for adults) or their legal representative (for children) to follow the guidelines of the medical device
- have given their written informed consent
Key exclusion criteria (6 listed)
- Patient with no cold symptoms, including no nasal congestion (chronic dry rhinitis…)
- Patient under treatment with cortisone derivative, mucolytic, or medication containing pseudoephedrine or related product acting on nasal congestion or having used such a product in the 3 days before inclusion
- Patient who used a nasal wash product in the 3 days before inclusion
- Patient allergic to seafood, or to any of the components of the products under study
- Vulnerable patient whose inclusion is not justified by the research objectives: woman pregnant, parturient, psychiatric patient, or adult subject to legal protection
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 |
|---|---|---|
| Sea water solutionAdministration of different sea water solution is performed and the rating of cold symptoms according to the Jackson scale, the fluidity of mucus and the ease of blowing will be evaluated. | Other | Ocean Bio Actif-Fluid+, Ocean Bio Active-Hygiene of the nose, Ocean Bio Active-Stuffy nose |
Primary outcome
Effect of nasal washing with a hypertonic seawater solution Nose hygiene).
Time frame: 3 days
Effect of nasal washing with a hypertonic seawater solution (Ocean Bio Actif-Fluid + or Ocean Bio Actif-Stuffy nose) on runny nose and nasal congestion during treatment after 3 days of use, compared to an isotonic solution (Ocean Bio Actif- Nose hygiene). symptom score (runny nose and nasal congestion) derived from the Jackson scale with a score of 0 to 3 for each (0: absent; 1: mild; 2: moderate; 3: severe) between Day 0 and Day 3.
8 secondary outcomes
Symptom score
Time frame: 7 days
Presence or absence of fluid mucus
Time frame: 7 days
Global Clinical Impression Scale
Time frame: between day 3 and day 7
Global Patient Impression Scale
Time frame: between day 3 and day 7
Use of medical device
Time frame: 7 days
Safety of medical device
Time frame: 7 days
Likert scale
Time frame: 7 days
Number of concomitant treatment
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alain BOYE, MD principal investigator
Coordinator of the study
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sea water solution in people with Rhinitis, run by YSLab 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 14 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nasal washing with a hypertonic seawater solution Nose hygiene). (time frame: 3 days). 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 14 Jul 2020.