Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT06104332
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2023-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
Sponsor:
Laboratoire de la Mer
Organization:
Study Overview
Official Title:
Post-marketing Clinical Investigation to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
Status:
COMPLETED
Status Verified Date:
2025-03
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:
The brief of this observational study is to evaluate usage, efficacy, safety and patient satisfaction of a range of hypertonic seawater-based decongestant nasal sprays in general population.
The main questions it aims to answer are:
* Usage,
* Efficacy,
* Safety,
* Satisfaction, in real-life usage with children, adults and pregnant or breastfeeding women. Participants will use the nasal spray as usual habits and complete daily questionnaires.
The main questions it aims to answer are:
* Usage,
* Efficacy,
* Safety,
* Satisfaction, in real-life usage with children, adults and pregnant or breastfeeding women. Participants will use the nasal spray as usual habits and complete daily questionnaires.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: