Common ColdPMCFNCT05960318
Post Market Clinical Follow-Up Study - Medical Device KalobaNaso
An observational study of Common Cold and Nasal Mucosal Inflammation, run by Schwabe Pharma Italia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Common Cold, Nasal Mucosal Inflammation, Rhinitis
- What is being tested?
- KalobaNaso spray and KalobaNaso junior spray
- Type of treatment
- Medical device
- How many people
- 131 participants
- Where
- 1 siteItaly
- Study dates
- 8 May 2023to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Customers of the pharmacies/parapharmacies involved
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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).
Read the 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
- Being tested
- KalobaNaso spray, KalobaNaso junior spray
- Medical subject headings
- Common Cold, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KalobaNaso sprayDevice
Nasal spray, 2 puff per nostril, 3 times a day
KalobaNaso junior sprayDevice
Nasal spray, 1 puff per nostril, 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Adolescents and adults | Adolescents from 12 years old and adults with common cold, nasal mucosa inflammation and/or rhinitis, who have bought the product. Receives: 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. Receives: Device: KalobaNaso junior spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Safety of the device during and after use
Measured: During and after use (from the first application to after maximum 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start8 May 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schwabe Pharma Italia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Floriana Raso, Study director, Schwabe Pharma Italia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960318
- Sponsor's protocol ID
- KN-01-2023
- Acronym
- PMCF
- Status last verified
- Sep 2023
- First submitted
- 4 Jul 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study on Medical Devices KalobaNaso Useful for Cold and Rhinitis in Adults and Children
- ClinicalTrials.gov ID
- NCT05960318
- Acronym / sponsor ID
- PMCF / KN-01-2023
- Conditions
- Common Cold, Nasal Mucosal Inflammation, Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Schwabe Pharma ItaliaIndustry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents and adults | – | Device: KalobaNaso sprayAdolescents from 12 years old and adults with common cold, nasal mucosa inflammation and/or rhinitis, who have bought the product. |
| Children | – | Device: KalobaNaso junior sprayChildren from 2 to 12 years old with common cold, nasal mucosa inflammation and/or rhinitis, whose parents/caregivers have bought the product. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Customers of the pharmacies/parapharmacies involved
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KalobaNaso sprayNasal spray, 2 puff per nostril, 3 times a day | Device | Adolescents and adults |
| KalobaNaso junior sprayNasal spray, 1 puff per nostril, 3 times a day | Device | Children |
Primary outcome
Resolution of the symptoms of nasal congestion
Time frame: Before use and at the resolution (after maximum 7 days)
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)
1 secondary outcome
Rate of known and unknown side-effects and / or other risks associated to the use of medical device
Time frame: During and after use (from the first application to after maximum 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Floriana Raso study director
Schwabe Pharma Italia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Cold and Nasal Mucosal Inflammation, run by Schwabe Pharma Italia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of the symptoms of nasal congestion (time frame: Before use and at the resolution (after maximum 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.