Acute RhinitisDEMECANCT06580210
Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction
An observational study of Acute Rhinitis and Nasal Obstruction, run by Laboratoires Gilbert at 3 sites in France.
Trial summary
The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Rhinitis, Nasal Obstruction, Rhinosinusitis
- How many people
- 114 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Oct 2024to 7 Dec 2026
- Phase
- Observational
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
Study population: Participation in the study is open to patients who buy the mechanical decongestant seawater spray on request or on the advice of their pharmacist. Patients are offered the opportunity to take part in the clinical investigation at the time of payment and after the eligibility critera have been checked by the pharmacist.
Who may be able to join
- 1. Patient ≥ 12 years,
- 2. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhynopharyngitis (cold), rhinosinusitis, or during non-infectious episodes as allergic rhinitis,
- 3. a. Informed adult patient who has given written consent prior to any study specific procedure,
- b. Informed minor patients 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 (questionnaire completion),
- 5. Patient affiliated to a social security scheme.
Who cannot join
- 1. Patient who does not want to participate to the clinical investigation,
- 2. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray,
- 3. A child with a history of febrile convulsions,
- 4. Diseases leading to respiratory insufficiency,
- 5. Patient suffering from nasal deformity or nasal polyps leading to chronic nasal obstruction,
- 6. Patient on local ans systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory (NSAIDs), antibiotics and local antiseptics,
- 7. Concomitant use of other nasal sprays, essential oils for local nasal use and nsal cream or gel,
- 8. Patient under guardianship, curatorship of safeguard of justice.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Pharmacie du Pont Saint Jean
Bayeux, 14400
Dr. Matthieu CHAUVIN, (0)231920763 ext. +33, matthieu.chauvin@yahoo.fr
- Recruiting
Pharmacie de la Guérinière
Caen, 14000
Benjamin BEAUCHENE, Dr, +33 (0)2 31 82 39 80, pharmaciedelagueriniere@gmail.com
Benjamin BEAUCHENE, Dr
- Not yet recruiting
Pharmacie de la Force
La Force, 24130
Dr Maxime DELARUE, +335-53-58-94-44, pharmaciedelaforce@gmail.com
About this study
Official title: Prospective Multicenter Clinical Investigation to Evaluate the Performance and the Safety of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert (DEMECA)
The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.
- Medical subject headings
- Common Cold, Nasal Obstruction, Rhinosinusitis, Nasopharyngitis, Rhinitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert at 3 days
Proportion of patients 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 pharmacy before using the spray) and Day 3 (in the evening after the last daily use of the spray). This item is scaled form 0 to 5 and 5 is the worst value.
Measured: From Day 0 to Day 3
Secondary outcomes (18)
Performance of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert after the first use
Proportion of patients who experienced an amelioration of their nasal obstruction after the first use of the spray at Day 0 on patient questionnaire.
Measured: At Day 0
Subjective feeling of reduced nasal obstruction on each day of use
Proportion of patients with a reduction in the symptom -nasal obstruction- of at least 1pt, in the SNOT22 Test (item 22), on each day of use (between Day 0 and Day 6). The item is scaled form 0 to 5 and 5 is the worst value.
Measured: From Day 0 and Day 6
Subjective feeling of nasal secretion thinning on each day of use
Proportion of patients presenting a change of the symptom -thick nasal discharge- by at least 1 pt, in the SNOT22 Test, and on each day of use (from Day 0 to Day 6)
Measured: From Day 0 to Day 6
Subjective feeling of nasal cavity cleansing (freshness) on each day of use
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).
Measured: From Day 0 to Day 6
Subjective feeling of relief of nasal irritation (mucous membrane) on each day of use
Proportion of patients who experienced relief of nasal irritation (mucous membrane), on Patient Questionnaire, on each day of use (from Day 0 to Day 6).
Measured: From Day 0 to Day 6
Subjective feeling of relief of nasal itching on each day of use
Proportion of patients who experienced relief of nasal itching, on Patient Questionnaire, on each day of use (from Day 0 to Day 6).
Measured: From Day 0 to Day 6
Subjective feeling of nasal cavity cleansing (freshness) immediately (2 minuts) after the use of the spray at Day 0
Proportion of patient who experienced nasal cavity cleansing (feeling of freshness) immediately (2 minuts) after the use of the spray, on Patient Questionnaire, at Day 0 and Day 6.
Measured: At Day 0 and Day 6
Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 6
Proportion of patient who experienced a reduction of nasal obstruction immediately (2 minuts) after the use of the spray, on Patient Questionnaire, at Day 6.
Measured: At Day 6
Subjective feeling of reduced nasal obstruction immediately (2 minuts) after the use of the spray at Day 0
Proportion of patient who experienced a reduction of nasal obstruction immediately (2 minuts) after the use of the spray, on Patient Questionnaire, at Day 0.
Measured: At Day 0
Improvement in the patient s quality of life after 7 days of use
Proportion of patients who experienced an improvement in quality of life, on Patient Questionnaire (scale of 0-10 with 10 is the best value), between Day 0 and Day 6.
Measured: At Day 0 et Day 6
Patient satisfaction with the spray after 7 days of use
Proportion of patients satisfied with the spray on a 4-points scale, at Day 6. The best value is -very satisfied- and the worst value is -very unsatisfied-.
Measured: At Day 6
Patient s recommendation of the spray after 7 days of use
Proportion of patients who would recommend the spray, on a 4-points scale, at Day 6. The best value is -definitely yes- and the worst value is -definitely no-.
Measured: At Day 6
Patient s willingness to continue using the spray at Day 6
Proportion of patients who will continue to use the spray and the reason if he does not want to continue, on a 4-points scale, at Day 6. The best value is -definitely yes- and the worst value is -definitely no-.
Measured: At day 6
Facility of use of the spray after 7 days of use
Proportion of patients who find the spray easy to use, on a 4-points scale, at Day 6. The best value is -very easy- and the worst value is -very difficult-.
Measured: At Day 6
Evolution of the overall severity of symptoms
Average SNOT22 score each day and comparison of SNOT22 score at Day 3 versus DAy 0 (baseline). [0 to 220] with 0 is the best value and 220 is the worst value.
Measured: At Day 0 and Day 3
Sensations of tingling and transient irritation
Proportion of patients with at least 1 adverse event among :
- tingling sensation
- sensations of transient irritation during the 7 days of use.
Measured: From Day 0 to Day 6
All device deficiencies reported by patients using the spray during the 7 days of use
Proportion of patients with at least 1 device deficiency during the clinical investigation.
Measured: From Day 0 to Day 6
All adverse events reported by patients using the spray during the 7 days of use
All adverse events reported by the patient during the clinical investigation.
Measured: From Day 0 to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start22 Oct 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion7 Dec 2026 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 114 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
- NCT06580210
- Sponsor's protocol ID
- 2022-A01585-38
- Acronym
- DEMECA
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No