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
Qualifiers
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
Treatments tested in this trial
- Treatment (22‰ Hypertonic seawater aerosol therapy solution)
Treatment groups
110 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov