Post-market Clinical Follow-up Study of an Isotonic Saline Solution to Manage Nasal Congestion in Case of Flu Symptoms, Colds, Allergic Rhinitis and Rhinosinusitis in Infants and Toddlers

NCT07257224 | Not Yet Recruiting

• 1 other identifier: NASBA01
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 2

Brief 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 in the management of nasal congestion in case of flu, colds, allergic rhinitis and rhinosinusitis in infants and toddlers aged 3 to 48 months at day 5 post-enrolment. Enrolment 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:

• 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.

Conditions

Nasal Congestion; Common Cold; Allergic Rhinitis; Rhinosinusitis; Flu Symptom

Keywords

infants; toddlers; Upper Respiratory Tract Infections; Pediatric nasal spray; nasal spray; Seawater isotonic solution; Post-market clinical follow-up (PMCF)

Outcome Measures

Primary Outcomes (2)

• 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).

  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 Quinton Medical Nasal Health Baby® as per its Instructions for Use.

  Baseline to Day 5

Secondary Outcomes (2)

• Safety - AEs, TRAEs, and SAEs up to Day 14

  Baseline to Day 14

• Functioning - Symptom improvement and participant guardian-reported outcomes up to Day 14

  Baseline to Day 14

Study Arms (1)

Pediatric Nasal Congestion Cohort

Infants and toddlers (3 to 48 months) with nasal congestion due to flu, colds, allergic rhinitis, or rhinosinusitis. All participants will use the CE-marked nasal spray according to its Instructions for Use.

Device: Quinton Medical Nasal Health Baby®

Interventions

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.

Pediatric Nasal Congestion Cohort

Eligibility Criteria

• Age: 3 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants and toddlers aged 3 to 48 months, both male and female, presenting with nasal congestion associated with flu, common cold, allergic rhinitis, or rhinosinusitis, recruited from pediatric clinical practices and pediatric physiotherapy clinics.

You may qualify if:

• Male and female infants / toddlers aged 3 to 48 months (inclusive) at the time of enrolment.
• Subjects with flu, cold, allergic rhinitis or rhinosinusitis as reported by their legal guardian(s) and/or medical history.
• Subjects presenting at least moderately bothersome nasal congestion (blocked or stuffy nose) as reported by their legal guardian(s) and/or medical history and confirmed by the site investigator through non-diagnostic inspection.
• 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 enrolment.
• 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.

You may not qualify if:

• Subjects with known hypersensitivity or intolerance to seawater or any of its natural mineral components (e.g., sodium, chloride, magnesium) as reported by their legal guardian(s) and/or medical history.
• Subjects showing severe symptoms such as persistent fever (\>38°C), severe cough, ear pain, or respiratory distress, as reported by their legal guardian(s) and/or medical history.
• Subjects whose legal guardian(s) and/or medical history report any ongoing medical diagnosis or treatment for acute infection or chronic respiratory disease (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, etc.).
• Subjects whose legal guardians(s) and/or medical history report any type of immunodeficiency.
• Subjects whose legal guardian(s) and/or medical history report a neurological condition that may affect respiratory functioning.
• Subjects with visible nasal injury, wounds or bleeding, or any condition that may contraindicate the use of the study device according to the device IFU.
• Subjects who are currently participating or have participated in another clinical investigation within the last 30 days prior to enrolment.
• Subjects using saline nasal drops or nasal sprays or pumps other than the study product within 12 hours prior to the time of enrolment or during the study.
• Subjects using the study product within 24 hours prior to the time of enrolment in the study.
• Subject using antibiotics, antivirals, intranasal medications, decongestants, antihistamines, mucolytics, echinacea, combination cold formulas, supplements containing ≥ 10 mg zinc that could influence symptom scores within 12 hours prior to the time of enrolment or during the study.

Sponsors & Collaborators

• Laboratoires Quinton International S.L.: lead

Study Sites (2)

Clínica Uner

Alicante, 03010, Spain

Location

Nombre de Mujer

Alicante, 03013, Spain

Location

MeSH Terms

Conditions

Nasal Obstruction; Common Cold; Rhinitis, Allergic; Rhinosinusitis; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Rhinitis; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sinusitis; Paranasal Sinus Diseases

Central Study Contacts

Ana Brotons Cantó, PhD

CONTACT

+34 681 216 183; ana.brotons@quinton.es

Laboratoires Quinton International, S.L.

CONTACT

+34 965 36 11 01; info@quinton.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)