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PMCF Study to Evaluate Performance and Safety of "NASAL SPRAYS " Used to Relieve Nasal Congestion and Dryness

NCT05843071 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-03-27

No results posted yet for this study

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 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).

Conditions

  • Nasal Congestion
  • Nasal Dryness

Interventions

DEVICE

Nasal sprays with sea salts

Nasal sprays for nasal congestion and dryness

Sponsors & Collaborators

  • C.O.C. Farmaceutici S.r.l.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-06-19
Completion
2023-06-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05843071 on ClinicalTrials.gov