Post Market Clinical Follow-Up Study - Medical Device KalobaNaso (PMCF)

Schwabe Pharma

Status

Completed

Conditions

Rhinitis

Nasal Mucosal Inflammation

Common Cold

Treatments

Device: KalobaNaso junior spray

Device: KalobaNaso spray

Study type

Observational

Funder types

Industry

Identifiers

NCT05960318

KN-01-2023

Details and patient eligibility

About

The goal of this observational PMCF study is to confirm the efficacy and safety of the medical device KalobaNaso (a nasal spray) in children, adolescents and adults with common cold symptoms, such as runny nose, nasal congestion and rhinitis. The main questions it aims to answer are:

Is the product effective in the treatment of common cold symptoms?
Is the product safe?

After buying the product, participants will be asked to fill in a questionnaire, in order to:

Assess the cold symptoms before the use of the nasal spray.
Assess the resolution of cold symptoms after the use of the nasal spray.
Describe the adverse effect(s)/problem(s) observed while using the product (if any).

Full description

The Medical Device Regulation (EU) 2017/745 (MDR) considers post-market clinical follow-up (PMCF) as a continuous process that aims to update the clinical evaluation and validate or reassess the benefit-risk balance of the medical device. The PMCF is an integral part of the manufacturer's post-market surveillance plan (PMS).

The medical device in question is CE marked since 2016, with no substantial modification.

The objectives of this Post Market Clinical Follow Up (PMCF) study are: verify the use of this device in a real situation, verify if its efficacy and safety of use are aligned with the provisions of the clinical evaluation; confirm or reassess the benefit/risk balance; update the risk analysis; identify any need for CAPA.

Specific product questionnaires have been developed based on the validated I-NOSE questionnaire, which aim to investigate aspects of Real-World Evidence on efficacy, safety, even in specific categories or situations, known and unknown adverse events, difficulties in use or completeness and clarity of IFUs.

Given the low-risk class of the device (class I - Dir.93/42/EEC), which is intended for use by lay people and normally sold in pharmacies / para-pharmacies, the sponsor planned to distribute the questionnaires to users that have purchased the product through health professionals (pharmacists), who are normally in charge of the distribution of the product.

The questionnaire was prepared in simple and easily understandable language for lay people.

The data requested during the filling of the questionnaire does not provide for the collection of information that allows the sponsor an identification of the participant.

Data will be collected and processed in a totally anonymous form.

Enrollment

131 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria adolescents ( > 12 years) and adults:

both sex, both smokers and not smokers, with symptoms of common cold, runny nose, nasal congestion, rhinitis, who bought the product by the pharmacy/parapharmacy involved.

Inclusion Criteria children (2 - 12 years old):

both sex, with symptoms of common cold, runny nose, nasal congestion, rhinitis, whose parents/caregivers bought the product by the pharmacy/parapharmacy involved

Exclusion Criteria adolescents (> 12 years) and adults:

children and adolescents under 12 years
Healthy volunteers and patients without symptoms associated to common cold, runny nose, nasal congestion, rhinitis,

Exclusion Criteria children (2-12 years old):

children < 2 years old
adolescents (>12 years old) and adults
Healthy volunteers and patients without symptoms associated to common cold, runny nose, nasal congestion, rhinitis,