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New treatment option for Upper Resp Tract Infection
Official title Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children
ClinicalTrials.gov ID: NCT07267689
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Adult subject voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification...
- Minor people (7-17 years old) given informed assent to investigation participation in writing encompassing consent to data recording and verification...
- Male and female people, 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.
- Subject willing to adhere to the requirements of the protocol, including availability for follow-up visits
You likely can't join if
- 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 with COVID or flu
See the full eligibility criteria
- Adult subject voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
- Minor people (7-17 years old) given informed assent to investigation participation in writing encompassing consent to data recording and verification procedures
- Male and female people, 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.
- Subject willing to adhere to the requirements of the protocol, including availability for follow-up visits
- Subject who agrees to no use decongestants, corticosteroids, antibiotics, allergen-specific immunotherapy, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), local nasal antiseptics, other nasal saline...
- Subject who is able to comply with the study requirements, at the Investigator's appreciation.
- For minor (\<18) people, parents/guardians willing and able to sign written consent
- Subject able and willing to use an internet-enabled device (computer, tablet, or smartphone) to complete study procedures (online questionnaires) and have regular access to a device with internet connectivity (personal...
- 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 with COVID or flu
- Subject presenting alarm symptoms (periorbital oedema/erythema, displaced globe, double vision, ophthalmoplegia, reduced visual acuity, severe headache, frontal swelling, signs of sepsis, sign of meningitis...
- 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 who used any decongestants, corticosteroids, antibiotics or allergen-specific immunotherapy within 4 weeks prior to inclusion;
- Subject who used any antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs) or local nasal antiseptics within 7 days prior to inclusion;
- Subject who used any nasal saline solutions or irrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics within 24 hours prior to inclusion;
- Subject with drug or alcohol abuse
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Częstochowa, Poland
- Kielce, Poland
- Krakow, Poland
- Poznan, Poland
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Częstochowa, Poland; Kielce, Poland; Krakow, Poland; Poznan, Poland; Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.