Phase
Condition
Respiratory Syncytial Virus (Rsv) Infection
Common Cold
Acute Rhinitis
Treatment
Treatment (22‰ Hypertonic seawater aerosol therapy solution)
Clinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult subject voluntarily given informed consent to investigation participation inwriting encompassing consent to data recording and verification procedures.
Minor subjects (7-17 years old) given informed assent to investigation participationin 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, acuterhinosinusitis or cold based on the medical examination done by the doctor.
Subject willing to adhere to the requirements of the protocol, includingavailability for follow-up visits
Subject who agrees to no use decongestants, corticosteroids, antibiotics,allergen-specific immunotherapy, antihistamines, non-steroidal anti-inflammatorydrugs (NSAIDs), local nasal antiseptics, other nasal saline solutions orirrigations, nasal sprays, nasal creams or gels, systemic analgesics or antipyretics (except paracetamol if needed);
Subject who is able to comply with the study requirements, at the Investigator'sappreciation.
For minor (<18) subjects, parents/guardians willing and able to sign written consent
Subject able and willing to use an internet-enabled device (computer, tablet, orsmartphone) to complete study procedures (online questionnaires) and have regularaccess to a device with internet connectivity (personal or household device) for theduration of the study.
Exclusion
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 with COVID or flu
Subject presenting alarm symptoms (periorbital oedema/erythema, displaced globe,double vision, ophthalmoplegia, reduced visual acuity, severe headache, frontalswelling, signs of sepsis, sign of meningitis, neurological signs) at the day ofinclusion
Subject known to have allergy to the components of the masks that is used with theinhalation 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 orallergen-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, nasalcreams or gels, systemic analgesics or antipyretics within 24 hours prior toinclusion;
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 orrecent (<3 months) participation in another investigational study involving a drugor combined device with drug.
Other condition preventing the subject to participate the study in theinvestigator's opinion: subject deemed unreliable or incapable of understanding andcomplying with the study assessment or unrealistic expectations of treatment results
Study Design
Study Description
Connect with a study center
Centrum Medyczne PZU Zdrowie
Kielce, 25-017
PolandSite Not Available
Centrum Medyczne Zdrowie
Kielce, 25-713
PolandSite Not Available
Centrum Medyczne Zdrowie
Kielce 769250, 25-713
PolandSite Not Available
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, 31-011
PolandSite Not Available
Krajmed Centrum Medyczne
Warsaw, 02-743
PolandSite Not Available

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