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Acute viral upper respiratory tract infection, also known as common cold, is the most frequently observed infectious disease in human beings. Although common cold is a self-limiting disease, symptoms such as runny nose, nasal congestion, sneezing, cough, sore throat, are troublesome.
Dry nose is characterized by nasal mucosa dryness, itching, mild burning, crusting, and dehydrated mucus. Causes of dry nose sensation include climatic factors, dry room air, workplace conditions, allergic rhinitis, endonasal sinus surgery.
Dry nose symptoms occur concurrently and may be the first signs of a common cold infection and rhinitis sicca (also known atrophic rhinitis).
Saline nasal sprays are broadly used as first-line treatment to relieve nasal congestion or nasal dryness. Isotonic saline solutions preferentially aim at cleansing and moistening of the nasal mucosa and thus are suitable for treatment of dry nose symptoms. Hypertonic saline solutions are generally used for decongestion of the nasal mucosa.
For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "NASAL SPRAYS" used to relieve nasal congestion and dryness.
The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with the use of "NASAL SPRAYS" according to the instruction for use (IFU).
Each pediatric subject whose parent(s)/legal guardian signed an Informed Consent Form (ICF), and each adult subject after signing the ICF, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed.
At baseline visit (V0), one of the "NASAL SPRAYS" will be administered to the enrolled subject.
The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.
The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according to the IFU, depend on various factors regarding the physiology of the patients (e.g. nasal congestion/ obstruction, sneezing), the age of the patient, and for pediatric subjects, their birth characteristics (e.g. age, prematurity, birthweight).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal spray treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal sprays with sea salts | Device | Nasal sprays for nasal congestion and dryness |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in nasal symptoms:To evaluate the performance of the "NASAL SPRAYS" used to relieve nasal congestion and dryness, through Visual Analogue Scale (VAS) for assessment of nasal symptoms | Visual Analogue Scale: Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome. | From baseline (V0 = Day 0) to 10 days (EOS/V2 - Day 10 ± 1) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of the "NASAL SPRAYS" through visual nasal examination and assessment of AEs including the relationship of the AE to the IP (e.g. local allergic reaction) | End of study visit (EOS/V2 - Day 10 ± 1) | |
| Change in Quality of life: to evaluate the capability of the "NASAL SPRAYS" to improve the (QoL), through Visual Analogue Scale (VAS) for assessment of QoL |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O.C otorinolaringoiatria, Policlinico Mater Domini | Catanzaro | CZ | 88100 | Italy |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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Visual Analogue Scale: Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome. |
| End of study visit (EOS/V2 - Day 10 ± 1) |
| To evaluate the parent(s), children or adults' satisfaction of the "NASAL SPRAYS" through a 5-points Likert scale | End of study visit (EOS/V2 = Day 10 ± 1) |
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |