Nasal CongestionNCT05365789
A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold
A study testing Blocked Nose Baby nasal spray in people with Nasal Congestion, run by Church & Dwight Company, Inc. at 1 site in Poland.
Trial summary
The study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold. Read more about this study
- Who is it for?
- Ages 3 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- Blocked Nose Baby nasal spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jan 2022to 31 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female infants and toddlers.
- Aged 3 - 48 months (inclusive) at enrolment (Day 0).
- Parent/legal guardian answering "yes" to the question "Do you feel that your child has a cold?" at enrolment.
- Subjects with symptoms started not later than 48 hours prior to enrolment (Day 0).
- Subjects with nasal congestion (blocked / stuffy nose) rated as at least score of 2 (moderately bothersome) on a 0 to 3-point scale, based on morning evaluation (within an hour of child awakening).
- Subjects showing at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough.
- Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
- Parent/legal guardian is cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol established by the clinical trial center could be expected.
Who cannot join
- Subjects presenting an oral temperature greater than 38°C at enrolment (Day 0).
- Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, etc.) at enrolment (Day 0).
- Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at inclusion.
- Subjects with a 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, etc).
- Subjects presenting any kind of immunodeficiency.
Show all 14Show fewer
- Subjects presenting any hypersensitivity or allergy or intolerance to any component of the study products or of the rescue medication (paracetamol)
- 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
- Subject who was abroad in a country with a higher incidence rate of Covid-19 than Poland, within 14 days before the beginning of the study.
- Subject who have had contact with any person infected with COVID-19 within 10 days before the beginning of the study.
- Subject who are currently home quarantined, as recommended by the Sanitary Inspection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial to Evaluate Efficacy and Safety of a Nasal Spray Combined With Standard of Care for Nasal Congestion in Infants and Toddlers With Common Cold in Comparison to Standard of Care Alone
The study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold.
Read the detailed description
The purpose of the present study is to test the efficacy, safety and tolerability of a product in relieving the symptoms of the common cold in children. This nasal spray is specifically studied for small children, classified as medical devices and is already on the market. Sterimar Blocked Nose Baby (CDEU048-28) nasal spray is a medical device and is a 100 ml bag-on-valve spray. The spray contains hypertonic solution based on 100% natural sea water rich of marine trace elements with added manganese and copper.
220 subjects will be included in this open label, randomized, parallel group, study product and standard of care versus standard of care study.
Study product will be used as 1 to 2 sprays per nostril (each "dose" is 1 or 2 sprays per nostril, the second spray only if needed), for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e., maximum 12 sprays per nostril each day). The 10 day study consists of 4 visits- Day 0 onsite, Days 3 and 6 telephone contact, and Day 10 onsite.
There will be 3 strata according to age: (3-12 months), (13-24 months) and (25-48 months). Every effort will be made to ensure at least 20% of subjects in each of the study groups are 3-12 months of age.
- Conditions
- Nasal Congestion
- Being tested
- Blocked Nose Baby nasal spray, Standard of care
- Keywords
- Pediatric
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blocked Nose Baby nasal sprayDevice
One or two nasal sprays will be administered to each nostril for a minimum of 2 times per day up to a maximum of 6 times per day for a maximum of 10 days.
Standard of careOther
Standard of care consists of hydration, rest at home and antipyretic paracetamol as necessary.
| Study group | Role | What they receive |
|---|---|---|
| Study Device and Standard of Care | Active comparator | 1 to 2 sprays per nostril of Sterimar Blocked Nose Baby for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e. maximum 12 sprays per nostril each day) until nasal symptoms are resolved, up to a maximum of 10 days.
Standard of care consists of hydration, rest at home and antipyretic paracetamol as necessary. Receives: Device: Blocked Nose Baby nasal spray; Other: Standard of care |
| Standard of Care | Other | Standard of care consists of hydration, rest at home and antipyretic medication paracetamol as necessary. Receives: Other: 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 reduction of nasal congestion, evaluated by means of a specific questionnaire ("Cold Symptom Severity Questionnaire") on a 0 to 3-point scale, with higher score indicating a worse outcome, with 0 =not at all, 1=mild, 2=moderate and 3=severe to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons between groups.
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"),on a 0 to 3-point scale, with higher score indicating a worse outcome, with 0=not at all, 1=mild, 2=moderate and 3=severe, to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons between groups.
Other cold symptoms: Stuffy nose, Nasal crust, Runny nose, 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; comparison between groups. Secondary infections will be confirmed by the Investigator.
Measured: Through study completion, an average of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start20 Jan 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, randomized, parallel group. Study product and standard of care versus standard of care.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Church & Dwight Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Rynkiewicz, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365789
- Sponsor's protocol ID
- ST-21-U58
- Status last verified
- Oct 2023
- First submitted
- 27 Jan 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen O, Prime C, Hooper W, Vanderzande T, Alegre M, Rynkiewicz A, Karpinska-Nowak A, Ghassemi A. Efficacy and safety of seawater-based nasal irrigation on nasal congestion in infants and toddlers with common cold: a randomized controlled trial. Eur Arch Otorhinolaryngol. 2026 Sep 16. doi: 10.1007/s00405-026-10615-z. Online ahead of print.
PubMed 42747526
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Evaluate Efficacy and Safety of a Nasal Spray Combined With Standard of Care for Nasal Congestion in Infants and Toddlers With Common Cold in Comparison to Standard of Care Alone
- ClinicalTrials.gov ID
- NCT05365789
- Acronym / sponsor ID
- ST-21-U58
- Conditions
- Nasal Congestion
- Keywords
- Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Church & Dwight Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 9 May 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 study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold.
Detailed description
The purpose of the present study is to test the efficacy, safety and tolerability of a product in relieving the symptoms of the common cold in children. This nasal spray is specifically studied for small children, classified as medical devices and is already on the market. Sterimar Blocked Nose Baby (CDEU048-28) nasal spray is a medical device and is a 100 ml bag-on-valve spray. The spray contains hypertonic solution based on 100% natural sea water rich of marine trace elements with added manganese and copper.
220 subjects will be included in this open label, randomized, parallel group, study product and standard of care versus standard of care study.
Study product will be used as 1 to 2 sprays per nostril (each "dose" is 1 or 2 sprays per nostril, the second spray only if needed), for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e., maximum 12 sprays per nostril each day). The 10 day study consists of 4 visits- Day 0 onsite, Days 3 and 6 telephone contact, and Day 10 onsite.
There will be 3 strata according to age: (3-12 months), (13-24 months) and (25-48 months). Every effort will be made to ensure at least 20% of subjects in each of the study groups are 3-12 months of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized, parallel group. Study product and standard of care versus standard of care.
| Arm | Type | Receives |
|---|---|---|
| Study Device and Standard of Care | Active comparator | Device: Blocked Nose Baby nasal spray, Other: Standard of care1 to 2 sprays per nostril of Sterimar Blocked Nose Baby for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e. maximum 12 sprays per nostril each day) until nasal symptoms are resolved, up to a maximum of 10 days. Standard of care consists of hydration, rest at home and antipyretic paracetamol as necessary. |
| Standard of Care | Other | Other: Standard of careStandard of care consists of hydration, rest at home and antipyretic medication paracetamol as necessary. |
Who may qualify
- Ages
- 3 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male and female infants and toddlers.
- Aged 3 - 48 months (inclusive) at enrolment (Day 0).
- Parent/legal guardian answering "yes" to the question "Do you feel that your child has a cold?" at enrolment.
- Subjects with symptoms started not later than 48 hours prior to enrolment (Day 0).
- Subjects with nasal congestion (blocked / stuffy nose) rated as at least score of 2 (moderately bothersome) on a 0 to 3-point scale, based on morning evaluation (within an hour of child awakening).
Key exclusion criteria (14 listed)
- Subjects presenting an oral temperature greater than 38°C at enrolment (Day 0).
- Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, etc.) at enrolment (Day 0).
- Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at inclusion.
- Subjects with a 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, etc).
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 |
|---|---|---|
| Blocked Nose Baby nasal sprayOne or two nasal sprays will be administered to each nostril for a minimum of 2 times per day up to a maximum of 6 times per day for a maximum of 10 days. | Device | Study Device and Standard of Care |
| Standard of careStandard of care consists of hydration, rest at home and antipyretic paracetamol as necessary. | Other | Standard of Care, Study Device and Standard of Care |
Primary outcome
Change of nasal congestion
Time frame: Through study completion, an average of 10 days.
Assess reduction of nasal congestion, evaluated by means of a specific questionnaire ("Cold Symptom Severity Questionnaire") on a 0 to 3-point scale, with higher score indicating a worse outcome, with 0 =not at all, 1=mild, 2=moderate and 3=severe to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons between groups.
2 secondary outcomes
Change of other cold symptoms
Time frame: Through study completion, an average of 10 days.
Occurrence of secondary infections
Time frame: Through study completion, an average of 10 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 26 Oct 2023.
- Derived from this study: PubMed 42747526Chen O, Prime C, Hooper W, Vanderzande T, Alegre M, Rynkiewicz A, Karpinska-Nowak A, Ghassemi A. Efficacy and safety of seawater-based nasal irrigation on nasal congestion in infants and toddlers with common cold: a randomized controlled trial. Eur Arch Otorhinolaryngol. 2026 Sep 16. doi: 10.1007/s00405-026-10615-z. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Anna Rynkiewicz, MD principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blocked Nose Baby nasal spray in people with Nasal Congestion, run by Church & Dwight Company, Inc. at 1 site in Poland.
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 14 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 26 Oct 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 Poland. 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 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?
On the ClinicalTrials.gov record for NCT05365789, which also lists 1 linked publication.
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 26 Oct 2023.