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Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and Children

NCT07267689 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-05-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate the tolerance, the performance and safety of this device, 22‰ Hypertonic seawater aerosol therapy solution in unidose container, to treat adult and peadiatric patients with of upper respiratory tract infection such as rhinopharyngitis, rhinitis, acute rhinosinusitis or cold.

The main questions it aims to answer are to assess if the 22‰ Hypertonic seawater solution used as aerosol therapy solution for inhalation:

* improve nasal symptoms relief;
* improve sleep quality;
* improve mucus fluidizing;
* is safe and well tolerated.

The study is none comparative and will assess prospectively the symptomatic and functional benefits, the tolerance and the general safety of the medical device when used as an aerosol therapy solution, measured by change from baseline.

Treatments will be done at home and participants will be required to perform two on sites visits and to complete questionnaires and scales for 7 consecutive days from the treatment starting.

Conditions

  • Upper Resp Tract Infection
  • Rhinitis Acute
  • Rhinopharyngitis
  • Cold Symptom
  • Rhinitis Viral

Interventions

DEVICE

Treatment (22‰ Hypertonic seawater aerosol therapy solution)

Treatment twice a day for 7 consecutive days with 22‰ Hypertonic seawater aerosol therapy solution used in association with a nebulizer

Sponsors & Collaborators

  • Laboratoires Gilbert

    lead INDUSTRY

Principal Investigators

  • Sebastian Kędzierski, Dr. · Centrum Medyczne PZU Zdrowie

  • Michal Tyrek, Dr. · Centrum Medyczne Pratia Częstochowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-21
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07267689 on ClinicalTrials.gov