Post Market Clinical Follow-Up Study - Medical Device KalobaNaso

NCT05960318 | Completed

• 1 other identifier: KN-01-2023
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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:
• 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).

Conditions

Common Cold; Nasal Mucosal Inflammation; Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of known and unknown side-effects and / or other risks associated to the use of medical device

  During and after use (from the first application to after maximum 7 days)

Study Arms (2)

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

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

Interventions

KalobaNaso spray DEVICE

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

Adolescents and adults

KalobaNaso junior spray DEVICE

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

Children

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Customers of the pharmacies/parapharmacies involved

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Schwabe Pharma Italia: lead

Study Sites (1)

Schwabe Pharma Italia

Neumarkt, Bolzano, 39044, Italy

Location

MeSH Terms

Conditions

Common Cold; Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases

Study Officials

• Floriana Raso

  Schwabe Pharma Italia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 25, 2023
• Study Start: May 8, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

IT (1)