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

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

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).

Study Overview

• Status: Completed
• Conditions: Rhinitis; Common Cold; Nasal Mucosal Inflammation
• Intervention / Treatment: Device: KalobaNaso spray; Device: KalobaNaso junior spray

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.

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Italy
  • Bolzano
    • Egna, Bolzano, Italy, 39044
      • Schwabe Pharma Italia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Customers of the pharmacies/parapharmacies involved

Description

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,

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adolescents and adults; Adolescents from 12 years old and adults with common cold, nasal mucosa inflammation and/or rhinitis, who have bought the product.	Device: KalobaNaso spray; 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.	Device: KalobaNaso junior spray; Nasal spray, 1 puff per nostril, 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of the symptoms of nasal congestion	A 6-items close question questionnaire developed based on I-NOSE (Italian-Nose Obstruction Symptom Evaluation), a validated and published questionnaire. It is a five-points scale with values from 0 to 4 (0= not a problem; 4 = severe problem)	Before use and at the resolution (after maximum 7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of known and unknown side-effects and / or other risks associated to the use of medical device	Safety of the device during and after use	During and after use (from the first application to after maximum 7 days)

Collaborators and Investigators

• Sponsor: Schwabe Pharma Italia
• Investigators: Study Director: Floriana Raso, Schwabe Pharma Italia

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Picornaviridae Infections; Nose Diseases; Inflammation; Rhinitis; Mucositis; Common Cold
• Other Study ID Numbers: KN-01-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No