Common ColdNCT05244148
Two Seawater-based Formulations for Relief of Nasal Congestion in Paediatric Subjects
A study testing IP1 - Stérimar BLOCKED NOSE Baby nasal spray in people with Common Cold and Nasal Congestion, run by Church & Dwight Company, Inc. at 1 site in Italy.
Trial summary
The objective of this clinical trial is to evaluate the tolerance and efficacy of two Stérimar nasal sprays products in children who have nasal congestion due to the common cold. Read more about this study
- Who is it for?
- Ages 3 to 48 months
- Conditions the study is for
- Common Cold, Nasal Congestion
- What is being tested?
- IP1 - Stérimar BLOCKED NOSE Baby nasal spray
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 25 Nov 2021to 20 Mar 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 3 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female infants and toddlers aged 3 - 48 months (inclusive) at enrolment (Day 0).
- Caretaker(s) answering "yes" to the question "Do you feel that your child has a cold?" at enrolment (Day 0).
- Subjects with symptoms started within 48 hours prior to enrolment (Day 0).
- Subjects with nasal congestion (blocked / stuffy nose) rated as at least grade 2 (moderately bothersome) on a 0 to 2-point scale, based on morning evaluation (within an hour of subject awakening).
- Subjects showing at least grade 2 on a 0 to 2-point scale for at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough.
- Legal caretaker(s) signed written informed consent for their young ones to participate in the study.
- Legal caretaker(s) willing to comply with all study procedures.
- Ability of the caretaker(s) (in the Investigator's opinion) to comprehend the full nature, procedures, and purpose of the study.
Who cannot join
- Subjects presenting a body temperature greater than 38°C measured with a non-contact infrared thermometer at enrolment (Day 0).
- Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, and so on) at enrolment (Day 0).
- Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at enrolment (Day 0).
- Subjects with history of allergic rhinitis.
- Subjects presenting any congenital or chronic disease that in the opinion of the Investigator would adversely affect the results of the study (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, and so on).
- Subjects presenting any kind of immunodeficiency.
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- Subjects presenting any hypersensitivity or allergy or intolerance to any component of the study products.
- Subjects with a positive medical history to any significant illness within the 2 weeks prior to the enrolment (Day 0).
- Subjects presenting any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
- Subjects currently participating or having participated in another clinical trial during the last 30 days prior to enrolment (Day 0).
- Subjects using saline nose drops or nasal sprays or pumps other than the study products, antibiotics, antivirals, intranasal medicines, decongestants, antihistamines, echinacea, combination cold formulas, supplements containing ≥ 10 mg zinc that would influence symptoms scores at enrolment (Day 0) within 12 hours prior the day of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Randomised, Open Label, Parallel Group, Controlled Clinical Trial to Evaluate Efficacy and Tolerability of Two Seawater-based Formulations Plus a Standard of Care Versus the Standard of Care Alone for Relief of Nasal Congestion in Paediatric Subjects With Common Cold
The objective of this clinical trial is to evaluate the tolerance and efficacy of two Stérimar nasal sprays products in children who have nasal congestion due to the common cold.
Read the detailed description
This clinical trial is a multicentre, randomized, parallel-group, controlled, open-label clinical trial to evaluate the efficacy of two Stérimar nasal sprays formulations (medical device already CE marked) for nasal congestion in children aged 3 to 48 months with common cold. In total the study foresees 300 patients divided between the different clinical sites.
- Conditions
- Common Cold, Nasal Congestion
- Being tested
- IP1 - Stérimar BLOCKED NOSE Baby nasal spray, IP2 - Stérimar Stop & Protect Cold Baby + standard of care, Standard of Care
- Keywords
- Common Cold, Nasal Congestion, Children
- Medical subject headings
- Common Cold, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP1 - Stérimar BLOCKED NOSE Baby nasal sprayDevice
1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.
IP2 - Stérimar Stop & Protect Cold Baby + standard of careDevice
1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.
Standard of CareBehavioural
hydration + rest at home + if needed paracetamol
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care Receives: Device: IP1 - Stérimar BLOCKED NOSE Baby nasal spray; Behavioral: Standard of Care |
| Group B | Experimental | IP2 - Stérimar Stop \& Protect Cold Baby + standard of care Receives: Device: IP2 - Stérimar Stop & Protect Cold Baby + standard of care; Behavioral: Standard of Care |
| Group C | Other | Standard of Care alone Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of nasal congestion.
Assess change of nasal congestion, evaluated by means of a specific questionnaire ("Cold Symptom Severity" questionnaire), to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons among groups A, B versus group C.
Measured: Through study completion, an average of 10 days
Secondary outcomes (2)
Change of other cold symptoms.
Assess change of other cold symptoms, evaluated by means of a specific questionnaire ("Cold Symptom Severity" questionnaire), to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons among groups; comparisons among groups A, B versus group C.
Other cold symptoms:
- Nasal crust (dry mucus)
- Runny nose (drip/sniff/snorting/drainage/discharge)
- Thick mucus
- Sneezing
- Cough.
Measured: Through study completion, an average of 10 days
Occurrence of secondary infections.
Assessment of occurrence of secondary infections (number) daily, from the beginning to the end of the study; comparisons of group A, B versus group C. Secondary infections will be confirmed by the Investigator.
Measured: Daily through the end of the study, approximately 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start25 Nov 2021
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Why it stopped: Unable to recruit 300 subjects.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 Arms: 1. Group A: IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care 2. Group B: IP2 - Stérimar Stop \& Protect Cold Baby + standard of care 3. Group C: Standard of Care alone
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Evidilya S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244148
- Sponsor's protocol ID
- ST-20-F11
- Status last verified
- Oct 2024
- First submitted
- 3 Jan 2022
- Last updated
- 3 Oct 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Open Label, Parallel Group, Controlled Clinical Trial to Evaluate Efficacy and Tolerability of Two Seawater-based Formulations Plus a Standard of Care Versus the Standard of Care Alone for Relief of Nasal Congestion in Paediatric Subjects With Common Cold
- ClinicalTrials.gov ID
- NCT05244148
- Acronym / sponsor ID
- ST-20-F11
- Conditions
- Common Cold, Nasal Congestion
- Keywords
- Common Cold, Nasal Congestion, Children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit 300 subjects.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Evidilya S.r.l.
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 17 Feb 2022 (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 objective of this clinical trial is to evaluate the tolerance and efficacy of two Stérimar nasal sprays products in children who have nasal congestion due to the common cold.
Detailed description
This clinical trial is a multicentre, randomized, parallel-group, controlled, open-label clinical trial to evaluate the efficacy of two Stérimar nasal sprays formulations (medical device already CE marked) for nasal congestion in children aged 3 to 48 months with common cold. In total the study foresees 300 patients divided between the different clinical sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 Arms: 1. Group A: IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care 2. Group B: IP2 - Stérimar Stop \& Protect Cold Baby + standard of care 3. Group C: Standard of Care alone
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: IP1 - Stérimar BLOCKED NOSE Baby nasal spray, Behavioral: Standard of CareIP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care |
| Group B | Experimental | Device: IP2 - Stérimar Stop & Protect Cold Baby + standard of care, Behavioral: Standard of CareIP2 - Stérimar Stop \& Protect Cold Baby + standard of care |
| Group C | Other | Behavioral: Standard of CareStandard of Care alone |
Who may qualify
- Ages
- 3 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male and female infants and toddlers aged 3 - 48 months (inclusive) at enrolment (Day 0).
- Caretaker(s) answering "yes" to the question "Do you feel that your child has a cold?" at enrolment (Day 0).
- Subjects with symptoms started within 48 hours prior to enrolment (Day 0).
- Subjects with nasal congestion (blocked / stuffy nose) rated as at least grade 2 (moderately bothersome) on a 0 to 2-point scale, based on morning evaluation (within an hour of subject awakening).
- Subjects showing at least grade 2 on a 0 to 2-point scale for at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough.
Key exclusion criteria (11 listed)
- Subjects presenting a body temperature greater than 38°C measured with a non-contact infrared thermometer at enrolment (Day 0).
- Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, and so on) at enrolment (Day 0).
- Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at enrolment (Day 0).
- Subjects with history of allergic rhinitis.
- Subjects presenting any congenital or chronic disease that in the opinion of the Investigator would adversely affect the results of the study (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, and so on).
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 |
|---|---|---|
| IP1 - Stérimar BLOCKED NOSE Baby nasal spray1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day. | Device | Group A |
| IP2 - Stérimar Stop & Protect Cold Baby + standard of care1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day. | Device | Group B |
| Standard of Carehydration + rest at home + if needed paracetamol | Behavioural | Group A, Group B, Group C |
Primary outcome
Change of nasal congestion.
Time frame: Through study completion, an average of 10 days
Assess change of nasal congestion, evaluated by means of a specific questionnaire ("Cold Symptom Severity" questionnaire), to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons among groups A, B versus group C.
2 secondary outcomes
Change of other cold symptoms.
Time frame: Through study completion, an average of 10 days
Occurrence of secondary infections.
Time frame: Daily through the end of the study, approximately 10 days
Results and safety
The study was stopped early (reason given: Unable to recruit 300 subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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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.
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 IP1 - Stérimar BLOCKED NOSE Baby nasal spray in people with Common Cold and Nasal Congestion, run by Church & Dwight Company, Inc. 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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 3 Oct 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 was stopped early (reason given: Unable to recruit 300 subjects.). Results are not available in the source record.
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 of nasal congestion. (time frame: Through study completion, an average of 10 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 3 Oct 2024.