Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sea water solution | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom score | The effect of nasal wash on the evolution of symptoms over time | 7 days |
| Presence or absence of fluid mucus | The effect of nasal wash on the evolution of the mucus fluidification over time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alain BOYE, MD | Coordinator of the study | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical office | Oignies | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 7 days |
| Global Clinical Impression Scale | Global Clinical Impression of the investigator on the evolution of symptoms | between day 3 and day 7 |
| Global Patient Impression Scale | Global Impression of the patient on the evolution of symptoms | between day 3 and day 7 |
| Use of medical device | Number of daily sprays | 7 days |
| Safety of medical device | Number of adverse events | 7 days |
| Likert scale | Satisfaction of patient for the medical device | 7 days |
| Number of concomitant treatment | concomitant administration of treatments related to rhinitis | 7 days |
| D010038 |
| Otorhinolaryngologic Diseases |