Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children (AIR)

Laboratoires Gilbert

Status

Begins enrollment in 1 month

Conditions

Upper Resp Tract Infection

Cold Symptom

Rhinitis Viral

Rhinitis Acute

Rhinopharyngitis

Treatments

Device: Treatment (22‰ Hypertonic seawater aerosol therapy solution)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07267689

MAR-2022-0832

Details and patient eligibility

About

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.

Full description

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 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.

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.

Enrollment

110 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 with URTIs such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.
Subject willing to adhere to the requirements of the protocol, including availability for follow-up visits
Subject who is able to comply with the study requirements, at the Investigator's appreciation.
For minor (<18) subjects, parents/guardians willing and able to sign written consent

Exclusion criteria

Person with hypersensitivity to seawater
Subject who previously undergone bronchospasm
Children under 2 years of age
Pregnant and breastfeeding women
Onset of URTI symptoms > 48 hours
Subject known to have allergy to the components of the masks that is used with the inhalation device;
Subject with asthma;
Subject presenting infection or pathology of the inferior respiratory tracts;
Subject with chronic nasal obstruction (polypes)
Subject agrees to not used other saline solutions (irrigation), nasal spray, antihistamines, steroids, antipyretics, analgesic, antibiotics, decongestants, local antispectic, essential oil for nasal use and gel or nasal cream during study participation
Subject with drug or alcohol abuse
Subjects who is deprived for their freedom by administrative or legal decision
Subject living in a social or sanitary establishment.
Subject being in an exclusion period for a previous study or with a current or recent (<3 months) participation in another investigational study involving a drug or combined device with drug.
Other condition preventing the subject to participate the study in the investigator's opinion: subject deemed unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment results.