NCT05960318

Post Market Clinical Follow-Up Study - Medical Device KalobaNaso

Post Market Clinical Follow-Up Study on Medical Devices KalobaNaso Useful for Cold and Rhinitis in Adults and Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 131 (actual)
• Sponsor: Schwabe Pharma Italia · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	KalobaNaso spray	Nasal spray, 2 puff per nostril, 3 times a day
DEVICE	KalobaNaso junior spray	Nasal spray, 1 puff per nostril, 3 times a day

Timeline

• Start date: 2023-05-08
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2023-07-25
• Last updated: 2023-09-07

Locations

1 site across 1 country: Italy