Nasal CongestionNCT05843071
PMCF Study to Evaluate Performance and Safety of "NASAL SPRAYS " Used to Relieve Nasal Congestion and Dryness
A study testing Nasal sprays with sea salts in people with Nasal Congestion and Nasal Dryness, run by C.O.C. Farmaceutici S.r.l. at 1 site in Italy.
Trial summary
Acute viral upper respiratory tract infection, also known as common cold, is the most frequently observed infectious disease in human beings. Although common cold is a self-limiting disease, symptoms such as runny nose, nasal congestion, sneezing, cough, sore throat, are troublesome. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Nasal Congestion, Nasal Dryness
- What is being tested?
- Nasal sprays with sea salts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 19 Jun 2023
- Phase
- Interventional
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pediatric subjects whose ICF will be signed by parent(s) or legal guardian;
- Adults' ICF signed;
- M \& F infants (6-23 months), children (2-11 years), or M \& F Aged ≥ 18 years at the time of the signature of the ICF;
- Infants, children or adults presenting with nasal congestion and/or nasal dryness.
- Willingness not to use other nasal sprays during the entire study.
Who cannot join
- Suspected other - different - conditions involving the respiratory tract (e.g. asthma, pneumonia);
- Suspected or known hypersensitivity or allergy to Investigational Product (IP) components;
- Suspected alcohol or drug abuse;
- Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. cystic fibrosis);
- Participation in another investigational study;
- Parent(s)' and/or patient's inability to follow all study procedures, including attending all site visits, tests and examinations;
- Parent(s)' and/or patient's mental incapacity that precludes adequate understanding or cooperation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
U.O.C otorinolaringoiatria, Policlinico Mater Domini
Catanzaro, CZ, 88100
About this study
Official title: An Interventional, Non-comparative, Single-center Post Marketing Clinical Follow-up (PMCF) Study to Evaluate Performance and Safety of "NASAL SPRAYS " Used to Relieve Nasal Congestion and Dryness
Acute viral upper respiratory tract infection, also known as common cold, is the most frequently observed infectious disease in human beings. Although common cold is a self-limiting disease, symptoms such as runny nose, nasal congestion, sneezing, cough, sore throat, are troublesome.
Dry nose is characterized by nasal mucosa dryness, itching, mild burning, crusting, and dehydrated mucus. Causes of dry nose sensation include climatic factors, dry room air, workplace conditions, allergic rhinitis, endonasal sinus surgery.
Read more
Dry nose symptoms occur concurrently and may be the first signs of a common cold infection and rhinitis sicca (also known atrophic rhinitis).
Saline nasal sprays are broadly used as first-line treatment to relieve nasal congestion or nasal dryness. Isotonic saline solutions preferentially aim at cleansing and moistening of the nasal mucosa and thus are suitable for treatment of dry nose symptoms. Hypertonic saline solutions are generally used for decongestion of the nasal mucosa.
For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "NASAL SPRAYS" used to relieve nasal congestion and dryness.
The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with the use of "NASAL SPRAYS" according to the instruction for use (IFU).
Each pediatric subject whose parent(s)/legal guardian signed an Informed Consent Form (ICF), and each adult subject after signing the ICF, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed.
At baseline visit (V0), one of the "NASAL SPRAYS" will be administered to the enrolled subject.
The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.
The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according to the IFU, depend on various factors regarding the physiology of the patients (e.g. nasal congestion/ obstruction, sneezing), the age of the patient, and for pediatric subjects, their birth characteristics (e.g. age, prematurity, birthweight).
- Conditions
- Nasal Congestion, Nasal Dryness
- Being tested
- Nasal sprays with sea salts
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal sprays with sea saltsDevice
Nasal sprays for nasal congestion and dryness
| Study group | Role | What they receive |
|---|---|---|
| Nasal spray treatment arm | Experimental | Not described Receives: Device: Nasal sprays with sea salts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nasal symptoms:To evaluate the performance of the "NASAL SPRAYS" used to relieve nasal congestion and dryness, through Visual Analogue Scale (VAS) for assessment of nasal symptoms
Visual Analogue Scale:
Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome.
Measured: From baseline (V0 = Day 0) to 10 days (EOS/V2 - Day 10 ± 1)
Secondary outcomes (3)
To evaluate the safety and tolerability of the "NASAL SPRAYS" through visual nasal examination and assessment of AEs including the relationship of the AE to the IP (e.g. local allergic reaction)
Measured: End of study visit (EOS/V2 - Day 10 ± 1)
Change in Quality of life: to evaluate the capability of the "NASAL SPRAYS" to improve the (QoL), through Visual Analogue Scale (VAS) for assessment of QoL
Visual Analogue Scale:
Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome.
Measured: End of study visit (EOS/V2 - Day 10 ± 1)
To evaluate the parent(s), children or adults' satisfaction of the "NASAL SPRAYS" through a 5-points Likert scale
Measured: End of study visit (EOS/V2 = Day 10 ± 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Sep 2022
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal CongestionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- C.O.C. Farmaceutici S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843071
- Sponsor's protocol ID
- COC-R8-NS
- Status last verified
- May 2023
- First submitted
- 13 Apr 2023
- Last updated
- 27 Mar 2024
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Non-comparative, Single-center Post Marketing Clinical Follow-up (PMCF) Study to Evaluate Performance and Safety of "NASAL SPRAYS " Used to Relieve Nasal Congestion and Dryness
- ClinicalTrials.gov ID
- NCT05843071
- Acronym / sponsor ID
- COC-R8-NS
- Conditions
- Nasal Congestion, Nasal Dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- C.O.C. Farmaceutici S.r.l.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 6 May 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.
Acute viral upper respiratory tract infection, also known as common cold, is the most frequently observed infectious disease in human beings. Although common cold is a self-limiting disease, symptoms such as runny nose, nasal congestion, sneezing, cough, sore throat, are troublesome.
Dry nose is characterized by nasal mucosa dryness, itching, mild burning, crusting, and dehydrated mucus. Causes of dry nose sensation include climatic factors, dry room air, workplace conditions, allergic rhinitis, endonasal sinus surgery.
Dry nose symptoms occur concurrently and may be the first signs of a common cold infection and rhinitis sicca (also known atrophic rhinitis).
Saline nasal sprays are broadly used as first-line treatment to relieve nasal congestion or nasal dryness. Isotonic saline solutions preferentially aim at cleansing and moistening of the nasal mucosa and thus are suitable for treatment of dry nose symptoms. Hypertonic saline solutions are generally used for decongestion of the nasal mucosa.
For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "NASAL SPRAYS" used to relieve nasal congestion and dryness.
The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with the use of "NASAL SPRAYS" according to the instruction for use (IFU).
Each pediatric subject whose parent(s)/legal guardian signed an Informed Consent Form (ICF), and each adult subject after signing the ICF, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed.
At baseline visit (V0), one of the "NASAL SPRAYS" will be administered to the enrolled subject.
The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.
The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according to the IFU, depend on various factors regarding the physiology of the patients (e.g. nasal congestion/ obstruction, sneezing), the age of the patient, and for pediatric subjects, their birth characteristics (e.g. age, prematurity, birthweight).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal spray treatment arm | Experimental | Device: Nasal sprays with sea salts |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pediatric subjects whose ICF will be signed by parent(s) or legal guardian;
- Adults' ICF signed;
- M \& F infants (6-23 months), children (2-11 years), or M \& F Aged ≥ 18 years at the time of the signature of the ICF;
- Infants, children or adults presenting with nasal congestion and/or nasal dryness.
- Willingness not to use other nasal sprays during the entire study.
Key exclusion criteria (7 listed)
- Suspected other - different - conditions involving the respiratory tract (e.g. asthma, pneumonia);
- Suspected or known hypersensitivity or allergy to Investigational Product (IP) components;
- Suspected alcohol or drug abuse;
- Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. cystic fibrosis);
- Participation in another investigational study;
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 |
|---|---|---|
| Nasal sprays with sea saltsNasal sprays for nasal congestion and dryness | Device | Nasal spray treatment arm |
Primary outcome
Change in nasal symptoms:To evaluate the performance of the "NASAL SPRAYS" used to relieve nasal congestion and dryness, through Visual Analogue Scale (VAS) for assessment of nasal symptoms
Time frame: From baseline (V0 = Day 0) to 10 days (EOS/V2 - Day 10 ± 1)
Visual Analogue Scale: Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome.
3 secondary outcomes
To evaluate the safety and tolerability of the "NASAL SPRAYS" through visual nasal examination and assessment of AEs including the relationship of the AE to the IP (e.g. local allergic reaction)
Time frame: End of study visit (EOS/V2 - Day 10 ± 1)
Change in Quality of life: to evaluate the capability of the "NASAL SPRAYS" to improve the (QoL), through Visual Analogue Scale (VAS) for assessment of QoL
Time frame: End of study visit (EOS/V2 - Day 10 ± 1)
To evaluate the parent(s), children or adults' satisfaction of the "NASAL SPRAYS" through a 5-points Likert scale
Time frame: End of study visit (EOS/V2 = Day 10 ± 1)
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 27 Mar 2024.
Related trials for Nasal Congestion
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
RecruitingPhase 3
Fixed-dose Combination of 1000 mg Dipyrone Monohydrate + 60 mg Caffeine + 4 mg Chlorpheniramine Maleate in Improving Symptoms of the Common Cold and Flu in Adults
Common Cold/Flu, Nasal Congestion
Not yet recruitingObservational study
Observational Study of RHINOSEDAL in Acute Nasal Obstruction
Nasal Obstruction, Common Cold
Active, not recruiting
Laser Posterior Nasal Nerve Neurolysis
Allergic Rhinitis, Chronic Rhinitis
Not yet recruiting
Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion
Atopic Rhinitis, Atopic Asthma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal sprays with sea salts in people with Nasal Congestion and Nasal Dryness, run by C.O.C. Farmaceutici S.r.l. 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 5 inclusion and 7 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 27 Mar 2024. 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?
Change in nasal symptoms:To evaluate the performance of the "NASAL SPRAYS" used to relieve nasal congestion and dryness, through Visual Analogue Scale (VAS) for assessment of nasal symptoms (time frame: From baseline (V0 = Day 0) to 10 days (EOS/V2 - Day 10 ± 1)). 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 27 Mar 2024.