Acute RhinitisDEVALPONCT05494346
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
A study testing Measurement of peak nasal flow. in people with Acute Rhinitis and Nasal Obstruction, run by Laboratoires Gilbert at 5 sites in France.
Trial summary
The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Rhinitis, Nasal Obstruction, Rhinosinusitis
- What is being tested?
- Measurement of peak nasal flow.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 5 sitesFrance
- Study dates
- 23 Jun 2023to 8 Jan 2027
- Phase
- Interventional
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patient ≥ 12 years.
- 2. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis.
- 3. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure.
- 4. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion.
- 5. Patient affiliated to a social security scheme.
Who cannot join
- 1. Pregnant and/or breastfeeding woman
- 2. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray.
- 3. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and/or respiratory insufficiency.
- 4. Patients with uncontrolled asthma (GINA score greater than or equal to 4)
- 5. Patients undergoing allergy desensitization
- 6. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels.
Show all 9Show fewer
- 7. Patients taking local and systemic vasoconstrictors, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics.
- 8. Concomitant use of other nasal sprays, essential oils for local nasal use, creams, or gels for the nose.
- 9. Patients under guardianship, conservatorship, or legal protection.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 3 recruiting
- Recruiting
Cabinet Médical
Blainville-sur-Orne, 14550
Dr. Pauline LE GALL, (0)2 31 44 73 49 ext. +33, docteur.legallpauline@gmail.com
- Recruiting
Cabinet Médical Caen
Caen, 14000
Pascal MABIRE, Dr
- Recruiting
MSP du Haut Anjou
Châteauneuf-sur-Sarthe, 49330
Dr. Anne-Charlotte ROCFORT, (0)978080400 ext. +33, dr.rocfort@gmail.com
- Withdrawn
Cabinet Médical Gainneville
Gainneville, 76700
- Completed
ALYATEC
Strasbourg, 67000
About this study
Official title: Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils
The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.
- Being tested
- Measurement of peak nasal flow.
- Medical subject headings
- Common Cold, Nasal Obstruction, Rhinosinusitis, Nasopharyngitis, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of peak nasal flow.Device
Peak nasal flow measurements will be performed before and after the first use of the spray at D0, as well as after the use of the spray at the medical office at D3 (only for arm A).
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Patients with peak nasal flow performed | Other | This arm is made up of major patients. Nasal flow point measurements will be performed at D0 and D3. Receives: Device: Measurement of peak nasal flow. |
| Arm B: No peak nasal flow | No intervention | This arm is made up of minor patients. Unlike arm A, nasal flow measurements will not be performed at D0 and D3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the Gilbert Laboratories pocket valve spray.
Proportion of patient presenting a change of the symptom "nasal obstruction" by at least 1 pt, in the SNOT22 Test (item 22), between Day 0 (at inclusion in the office before use of the spray) and Day 3 (in the evening after last daily use of the spray).
This item is scaled from 0 to 5, 5 being the worst value.
Measured: From Day 0 to Day 3
Secondary outcomes (15)
Change of nasal obstruction between Day 0 and Day 3
Proportion of patients with a change in Peak Inspiratory Nasal Flow value of at least 30 L/min between Day 0 (before use of the spray) and Day 3 (after use of the spray) (arm A).
[0 - 350 L/min] 350 L/min means a better outcome.
Measured: From Day 0 to Day 3
Immediate change of nasale obstruction at D0 on first use (Arm A)
Proportion of patients with a change in Peak Inspiratory Nasal Flow value of at least 30 L/min from pre- to post-spray measurements at Day 0 (arm A).
[ 0 - 350 L/min] 350 L/min means a better outcome.
Measured: At Day 0
Subjective feeling of reduced nasal obstruction on each day of use (arms A+B).
Proportion of patients with a reduction in the symptom "nasal obstruction" of at least 1pt, on SNOT22 (Sino-Nasal Outcome Test 22), and on each day of use (from Day 0 to Day 6) (arms A+B).
This item is scaled from 0 to 5, 5 being the worst value.
Measured: From Day 0 to Day 6
Subjective feeling of nasal cavity cleansing (freshness) each day of use (arms A+B).
Proportion of patients who experienced nasal cavity cleansing (feeling of freshness), on Patient Questionnaire, and on each day of use (from Day 0 to Day 6) (arms A+B).
Measured: From Day 0 to Day 6
Subjective feeling of nasal secretion thinning on each day of use (arms A+B).
Proportion of patients with a change in the symptom "thick nasal discharge" of at least 1pt, on SNOT22, and on each day of use (Day 0 to Day 6) (arms A+B).
This item is scaled from 0 to 5, 5 being the worst value.
Measured: From Day 0 to Day 6
Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use (arms A+B).
Proportion of patients who experienced relief of nasal (mucosal) irritation, on each day of use (Day 0 to Day 6) (arms A+B).
Measured: From Day 0 to Day 6
Subjective feeling of relief of nasal itching on each day of use (arms A+B).
Proportion of patients who experienced relief of nasal itching, on Patient Questionnaire, and on each day of use (Day 0 to Day 6) (arms A+B).
Measured: From Day 0 to Day 6
Speed of action at which the patient feels (subjectively) a decrease in nasal obstruction at D0 and D3 (arms A+B).
Proportion of patients with a change in immediate nasal obstruction after use of the spray, on Patient Questionnaire, at Day 0 and Day 3 (arms A+B).
Measured: At Day 0 and Day 3
Speed of action at which the patient feels (subjectively) a purification of his nasal cavities (sensation of freshness) at D0 and D3 (arms A+B).
Proportion of patients who experienced immediate nasal cleansing (feeling of freshness) after use of the spray at Day 0 and Day 3 (arms A+B).
Measured: At Day 0 and Day 3
Improvement in the patient's quality of life after 7 days of use (arms A+B).
Proportion of patients who experienced an improvement in quality of life, defined as an increase of at least 1pt on a scale of 0-10 between Day 0 and Day 6 (A+B arm).
10 mean a better value.
Measured: From Day 0 to Day 6
Patient satisfaction with the medical device after 7 days of use (arm A+B).
Proportion of patients satisfied with the medical device, on a 4-point scale, at Day 6 (arm A+B).
The better value is "very satisfied" and the worst value is "very unsatisfied". Proportion of patients who would recommend the medical device at Day 6 (arms A+B).
Proportion of patients who will continue to use the medical device , and the reason if not, (arms A+B).
Measured: At Day 6
Facility of use of the medical device after 7 days of use (arm A+B)
Proportion of patients who find the medical device easy to use, on day 6 (Arms A+B)
Measured: At Day 6
Evolution of the overall severity of symptoms (arm A+B).
Mean SNOT22 score on each day. Comparison of SNOT22 score at Day 3 versus Day 0 baseline (arms A+B).
[ 0 to 220 ] 0 is the better value.
Measured: At Day 0 and Day 3
Sensations of tingling and transient irritation (arms A+B).
Proportion of patients with at least 1 adverse event between 1st and last use of the medical device among the following adverse events (arms A+B):
- Tingling sensations
- Sensations of transient irritation
Measured: From Day 0 to Day 6
All adverse events reported by patients using the pocket valve spray after 7 days of use (arm A+B).
All adverse events reported by the patient during the study (arm A+B).
Measured: From Day 0 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start23 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion8 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Gilbert
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494346
- Sponsor's protocol ID
- 2021-A01898-33
- Acronym
- DEVALPO
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2022
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No