NCT05843071

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

Completed NA Last updated 27 March 2024

What this trial tests

NA trial testing Nasal sprays with sea salts in Nasal Congestion in 105 participants. Completed in 19 June 2023.

Timeline

1 September 2022

Primary endpoint
19 June 2023

19 June 2023

Quick facts

Lead sponsor	C.O.C. Farmaceutici S.r.l.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	1 September 2022
Primary completion	19 June 2023
Estimated completion	19 June 2023
Sites	1 location across Italy

Drugs / interventions tested

• Nasal sprays with sea salts

Conditions studied

• Nasal Congestion — all drugs for Nasal Congestion →
• Nasal Dryness — all drugs for Nasal Dryness →

Sponsor

C.O.C. Farmaceutici S.r.l.

Who can join

6 Months and older, any sex, with Nasal Congestion or Nasal Dryness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.