Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05843071
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2023-04-13
Brief Title:
PMCF Study to Evaluate Performance and Safety of NASAL SPRAYS Used to Relieve Nasal Congestion and Dryness
Sponsor:
COC Farmaceutici Srl
Organization:
COC Farmaceutici Srl
Study Overview
Official Title:
An Interventional Non-comparative Single-center Post Marketing Clinical Follow-up PMCF Study to Evaluate Performance and Safety of NASAL SPRAYS Used to Relieve Nasal Congestion and Dryness
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 parentslegal 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 V2EOS 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 eg nasal congestion obstruction sneezing the age of the patient and for pediatric subjects their birth characteristics eg age prematurity birthweight
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 parentslegal 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 V2EOS 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 eg nasal congestion obstruction sneezing the age of the patient and for pediatric subjects their birth characteristics eg age prematurity birthweight
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None