Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorLaboratoires Gilbert
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult subject voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
Minor subjects (7-17 years old) given informed assent to investigation participation in writing encompassing consent to data recording and verification procedures
Male and female subjects, aged from 2 years old;
Subject diagnosed with URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold based on the medical examination done by the doctor.
Disqualifiers
Person with hypersensitivity to seawater
Subject who previously undergone bronchospasm
Children under 2 years of age
Pregnant and breastfeeding women
Trial design
Design model
Single group
Treatments tested in this trial
Treatment (22‰ Hypertonic seawater aerosol therapy solution)
DeviceTreatment twice a day for 7 consecutive days with 22‰ Hypertonic seawater aerosol therapy solution used in association with a nebulizer
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: Patient treated with 22‰ Hypertonic seawater solution, used as aerosol therapy for inhalatiExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
- 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 32
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 3Secondary outcomes
1
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 82
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 83
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 74
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 7Other outcomes
1
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 completed by parents for the minor patients of 2 to 3 years old.
Change in global WURSS-K score as measured in the morning before treatment on Day 1 and Day 3 .
Time frame
At Day 1 and Day 32
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 completed by parents for the minor patients of 2 to 3 years old
Change in global WURSS-K score as measured in the morning before treatment at Day 2, at Day 4, at Day5, 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 83
Evaluate the satisfaction of use of the device.
Assessment by the user (patient or patient's parent for minors) of the overall satisfaction of use with a satisfaction questionnaire
Time frame
Day 8Sponsors and contacts
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Source ClinicalTrials.gov