An observational study in Acute Rhinitis, Nasal Obstruction and Rhinosinusitis, sponsored by Laboratoires Gilbert. Recruiting at 3 sites in France. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Laboratoires Gilbert · Observational
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.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's planned enrollment of 114 is close to the median of 114 across 25 observational studies indexed under Common Cold.
Browse Common Cold studies →Laboratoires Gilbert is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: From Day 0 to Day 3
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.
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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-.
Time frame: 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-.
Time frame: 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-.
Time frame: 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-.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 0 to Day 6
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Nov 2026, 25 months after the start.
Of 12 observational studies under Common Cold, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 35. This study's planned 25 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Laboratoires Gilbert