The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold. The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation: * improve nasal symptoms relief; * improve sleep quality; * improve mucus fluidizing; * is safe and well tolerated. The study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline. Treatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.
Hypertonic seawater-based solution is a simple and well-known product. The performance of these solutions has been established in paediatric (infants, children), and in adult populations. The mode of action is based on the physical (mechanical) osmotic effect of the solution. Hypertonic saline induces an osmotic flow of water into the mucus layer, rehydrating the airway surface liquid and improving mucus clearance. Hypertonic saline also reduces viscosity and elasticity of mucus. Hypertonic saline solution (seawater based or not) can be used for intranasal wash, or in association with a nebulization system as an aerosol therapy solution for inhalation. Inhalation via nebulization allows the formation of fine particles or liquid droplets in a gas. In this study, 22‰ Hypertonic seawater solution, in unidose container, manufactured by Laboratoires Gilbert will be used as an aerosol therapy solution for inhalation in the treatment of URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold. The investigational medical device 22‰ Hypertonic seawater solution from Laboratoires Gilbert will be used in association with a nebulization system. The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold. The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation: * improve nasal symptoms relief; * improve sleep quality; * improve mucus fluidizing; * is safe and well tolerated. The study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline. Treatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Treatment twice a day for 7 consecutive days with 22‰ Hypertonic seawater aerosol therapy solution used in association with a nebulizer
Centrum Medyczne Pratia Częstochowa
Częstochowa, Poland
Centrum Medyczne PZU Zdrowie
Kielce, Poland
Centrum Medyczne Zdrowie
Kielce, Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, Poland
Centrum Medyczne Pratia Poznań
Poznan, Poland
Krajmed Centrum Medyczne
Warsaw, Poland
- Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.
Change in global WURSS-21 score as measured in the morning before treatment on Day 1 and Day 3 .
Time frame: From Day 1 to Day 3
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire in minor patients from 4 to 13 years old.
Change in global WURSS-K score as measured in the morning before treatment on Day 1 and Day 3.
Time frame: From Day 1 to Day 3
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-21 questionnaire in minor patients from 14 years old and adults.
Change in global WURSS-21 score as measured in the morning before treatment at Day2, at Day 4, at Day 5, at Day 6, at Day 7 and at Day 8 compared to Day 1 (before treatment) as baseline.
Time frame: Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8
Evaluate the performance of 22‰ Hypertonic seawater solution, used as aerosol therapy solution for inhalation, on the evolution of nasal symptom relief using the WURSS-K questionnaire in minor patients from 4 to 13 years old.
Change in global WURSS-K score as measured in the morning before treatment at Day 2, at Day 4, at Day 5, at Day 6, at Day 7 and at Day 8 compared to Day 1 (before treatment) as baseline.
Time frame: Day 1, Day 2, Day 4, Day 5, Day 6, Day 7 and Day 8
Assess the immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Change in VAS (Visual Analog Scale) score before and immediately after treatment (nasal symptom relief).
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the proportion of patients that note an immediate benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Proportion of patients reporting improvement in nasal symptom relief (defined as a VAS increase of more than 3 points on a 10-point scale) immediately after treatment.
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief.
Change in VAS (Visual Analog Scale) score before treatment and 3 hours post-treatment (nasal symptom relief).
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the proportion of patients that note a sustained benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on nasal symptom relief during the day.
Proportion of patients reporting improvement in nasal symptom relief (defined as a VAS increase of more than 3 points on a 10-point scale) 3 hours post- treatment
Time frame: Day 1, Day 3, Day 5 and Day 7
Assess the benefit of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation in improving sleep quality.
Improvement in sleep quality defined as a VAS score increase of more than 3 points on a 10-point scale, in the morning following evening treatment compared to baseline (assessment at Day 1 before treatment regarding the sleep quality during the night between Day 0 and Day 1).
Time frame: Day 1 before treatment, Day 2, Day 3, Day 5 and Day 7
Assess the proportion of patients reporting an improvement of sleep quality following evening treatment with the of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.
Proportion of patients reporting improvement in sleep quality (defined as a VAS increase of more than 3 points on a 10-point scale), in the morning following evening treatment with the device compared to baseline (assessment at Day 1 before treatment regarding the sleep quality during the night between Day 0 and Day 1)
Time frame: Day 1 before treatment, Day 2, Day 3, Day 5 and Day 7
Evaluate the performance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation on the improvement of mucus fluidizing
Assess performance to improve mucus fluidizing (6-point Likert scale) 6-point-Likert scale: 0 (None) - 1 (Very mild) - 2 (Mild) - 3 (Moderate) - 4 (Strong) - 5 (Very strong). Lower score means a worse outcome.
Time frame: Day 1, Day 3, Day 5, Day 7
Evaluate the overall patient's satisfaction.
Assessment by the patient of the overall satisfaction through 5-point Likert scale ((1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied)) at Day 8.
Time frame: Day 8
Evaluate the overall tolerance of 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation.
Assessment by the investigator of the occurrence of adverse device effect related to the use of 22‰ Hypertonic seawater solution when used as aerosol therapy solution for inhalation.
Time frame: From Day 1 to Day 7
Evaluate the overall safety of 22‰ Hypertonic seawater solution throughout the study.
Assessment by the investigators of the occurrence and severity of adverse events (AE)
Time frame: From Day 0 to Day 8
Evaluate the device related complications rates throughout the study.
Assessment of the proportion of patients with at least one adverse device effect related to the use of 22‰ Hypertonic seawater solution as an aerosol therapy solution for inhalation .
Time frame: From Day 1 to Day 7
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