Post Market Clinical Follow-Up Study - Medical Device KalobaNaso

NCT ID: NCT05960318

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 131 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2023-07-31

Brief Summary

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:

1. Assess the cold symptoms before the use of the nasal spray.

2. Assess the resolution of cold symptoms after the use of the nasal spray.

3. Describe the adverse effect(s)/problem(s) observed while using the product (if any).

Detailed 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.

Conditions

Common Cold; Nasal Mucosal Inflammation; Rhinitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Adolescents and adults

Adolescents from 12 years old and adults with common cold, nasal mucosa inflammation and/or rhinitis, who have bought the product.

KalobaNaso spray

Intervention Type: DEVICE

Nasal spray, 2 puff per nostril, 3 times a day

Children

Children from 2 to 12 years old with common cold, nasal mucosa inflammation and/or rhinitis, whose parents/caregivers have bought the product.

KalobaNaso junior spray

Intervention Type: DEVICE

Nasal spray, 1 puff per nostril, 3 times a day

Interventions

KalobaNaso spray

Nasal spray, 2 puff per nostril, 3 times a day

Intervention Type: DEVICE

KalobaNaso junior spray

Nasal spray, 1 puff per nostril, 3 times a day

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

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

• 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,

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schwabe Pharma Italia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Floriana Raso

Role: STUDY_DIRECTOR

Schwabe Pharma Italia

Locations

Schwabe Pharma Italia

Neumarkt, Bolzano, Italy

Countries

Italy

Other Identifiers

KN-01-2023

Identifier Type: -

Identifier Source: org_study_id