Nasal CongestionNASBYNCT07257224
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
An observational study of Nasal Congestion and Common Cold, run by Laboratoires Quinton International S.L. at 2 sites in Spain.
Trial summary
The goal of this observational post-market clinical follow-up study is to evaluate the safety and performance of the CE-marked nasal spray for the relief of nasal congestion in infants and toddlers aged 6 to 48 months at day 5 post-enrollment. Read more about this study
- Who is it for?
- Ages 6 to 48 months
- Conditions the study is for
- Nasal Congestion, Common Cold, Allergic Rhinitis
- What is being tested?
- Quinton Medical Nasal Health Baby®
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2026to Nov 2027
- Phase
- Observational
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 to 48 months
- All sexes
- No healthy volunteers
- Child
Study population: Male and female infants / toddlers aged 6 to 48 months with nasal congestion, as reported by their legal guardian(s), identified during routine consultations in specialized physiotherapy clinics.
Who may be able to join
- Male and female infants / toddlers aged 6 to 48 months (inclusive) at the time of enrollment.
- Subjects presenting a nasal congestion VAS score ≥ 4/10, as reported by their legal guardian(s).
- Presence of nasal congestion confirmed by the investigator during the screening visit based on externally observable signs.
- Subjects suitable for nasal hygiene treatment with the study device according to its IFU
- Subjects with nasal congestion symptoms that began within 48 hours prior to enrollment.
- Subjects whose legal guardian(s) signed written informed consent on their behalf to participate in the study.
- Subject whose legal guardian(s) are willing and able to follow the IFU and comply with all study procedures.
Who cannot join
- Subjects who are currently participating in another clinical investigation.
- Subjects using saline nasal drops or nasal sprays or pumps other than the study product within 12 hours prior to the time of enrollment or during the study.
- Subjects using the study product within 24 hours prior to the time of enrollment in the study.
- If any severe symptoms are seen in the subject, the guardian will be advised to seek medical evaluation by the subject's physician.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Clínica Uner
Alicante, 03010
María Jesús Gómez López, +34 965 124 686, info@clinicauner.es
Aitor Baño Alcaraz, Physiotherapist and Osteopath
Nombre de Mujer
Alicante, 03013
África Pol Calderón, Physiotherapy, 686 16 48 53, info@nombredemujer.es
África Pol Calderón, Physiotherapist
About this study
The goal of this observational post-market clinical follow-up study is to evaluate the safety and performance of the CE-marked nasal spray for the relief of nasal congestion in infants and toddlers aged 6 to 48 months at day 5 post-enrollment. Enrollment does not require establishing a medical diagnosis; eligibility is based on guardian-reported nasal congestion consistent with lay use of the device.
Participants will be:
Read more
- Evaluated by a healthcare professional for eligibility.
- Receive treatment with the CE-marked nasal spray according to its Instructions for Use, for up to 14 days.
- Have their legal guardians report symptom severity and improvement using standardized scales (Visual Analog Scale) during follow-up visits on Day 2, Day 5, and Day 14 and device usability on Day 14.
This study does not include a comparison group and reflects real-world use of the device in routine pediatric care.
Read the detailed description
This is a prospective, observational, post-market clinical follow-up (PMCF) study designed to collect real-world data on the safety and performance of an isotonic seawater nasal spray for the relief of nasal congestion in infants and toddlers aged 6 to 48 months at day 5 post-enrollment.
The device is CE-marked as a Class IIa medical device under MDR 2017/745 and is already commercially available. Therefore, no investigational assignment or randomization is required. Participants will use the marketed device according to its Instructions for Use.
The study will enroll children who meet defined inclusion and exclusion criteria and whose legal guardians provide informed consent. Follow-up assessments are scheduled at Day 2, Day 5, and Day 14, with the primary evaluation point at Day 5. Legal guardians will report outcomes such as nasal congestion relief, secretion clearance, and breathing improvement using validated Visual Analog Scales (VAS). Safety data, including adverse events, will be collected throughout the 14-day period.
The primary objective is to confirm short-term safety and performance at Day 5. Secondary objectives include assessing sustained effects and safety through Day 14, subject legal guardian's satisfaction, and impact on sleep quality.
This study is being conducted at two centers in Spain and is expected to recruit over a 10-month period, with a total study duration of approximately 11 months.
Results will provide additional clinical evidence to support the continued safe and effective use of isotonic seawater nasal sprays in paediatric patients.
- Conditions
- Nasal Congestion, Common Cold, Allergic Rhinitis, Rhinosinusitis, Flu Symptom
- Being tested
- Quinton Medical Nasal Health Baby®
- Keywords
- infants, toddlers, Upper Respiratory Tract Infections, Pediatric nasal spray, nasal spray, Seawater isotonic solution, Post-market clinical follow-up (PMCF)
- Medical subject headings
- Nasal Obstruction, Common Cold, Rhinitis, Allergic, Rhinosinusitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinton Medical Nasal Health Baby®Device
CE-marked Class IIa isotonic seawater nasal spray intended for nasal hygiene and relief of nasal congestion in infants and toddlers. In this study, the device will be administered according to its Instructions for Use, up to 6 applications per day, for a maximum of 14 days. Participants will be evaluated at Day 2, Day 5, and Day 14 for symptom relief, nasal discharge clearance, breathing improvement, sleep quality, and safety outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Nasal Congestion Cohort | Male and female infants / toddlers aged 6 to 48 months with nasal congestion, as reported by their legal guardian(s), identified during routine consultations in specialized physiotherapy clinics. All participants will use the CE-marked nasal spray according to its Instructions for Use. Receives: Device: Quinton Medical Nasal Health Baby® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Treatment-related AEs and SAEs at Day 5 Performance - Improvement in nasal congestion improvement indicators at Day 5
Safety: Occurrence of Treatment-related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) at day 5 post-enrolment with daily device use as per the device Instructions for Use (IFU).
Performance: Relief of nasal congestion, improvement in nasal discharge clearance and improvement of breathing at day 5 post-enrolment with daily device use as per IFU assessed by VAS (0-10) by legal guardian(s).
Measured: Baseline to Day 5
Functioning - Symptom improvement at Day 5
Change in participant caregiver-reported symptom severity (nasal congestion, nasal discharge clearance, and breathing) using a Visual Analog Scale (VAS, 0-10) from baseline to Day 5 with daily treatment with the nasal spray as per its Instructions for Use.
Measured: Baseline to Day 5
Secondary outcomes (2)
Safety - AEs, TRAEs, and SAEs up to Day 14
Number and proportion of participants experiencing any adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs) during the 14-day study period.
Measured: Baseline to Day 14
Functioning - Symptom improvement and participant guardian-reported outcomes up to Day 14
Change in participant guardian-reported symptom severity (nasal congestion, secretion clearance, and breathing) at Days 2, and 14 compared to baseline using VAS (0-10); time to onset of perceived symptom relief; frequency of analgesic use; improvement of sleep quality at Days 2, 5 and 14 compared to baseline; and guardian's satisfaction at Day 14 using a 7-point Likert scale.
Measured: Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Quinton International S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257224
- Sponsor's protocol ID
- NASBY01
- Acronym
- NASBY
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor does not plan to share individual participant data with other or external researchers. All data will be pseudonymised and assigned a study-specific code before being entered into an electronic data collection system. Each site will have access only to the data of participants recruited at their own centre.