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Not yet recruiting NCT07204158

Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray

No phase Interventional Nasal Dryness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spray pompe nasal confort.
Who it may be relevant to
Registry conditions: Nasal Dryness. Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Performance Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray in Children and Adults With Nasal Dryness: a Prospective, Multicentric, Non-randomized Study in Real-life Conditions.

Overview

The purpose of this study is to see whether the nasal spray can help improve hydration of the nasal mucosa, reduce discomfort linked to nasal dryness, and confirm its safety in patients suffering from nasal dryness.

Interventions

  • Device Spray pompe nasal confort
    Seawater solution with hyaluronan

Primary outcome measures

  • Improvement of the nasal dryness symptoms [Time frame: From enrollment to the end of treatment at 1 week]
Secondary outcome measures (2)
  • Improvement of the total perceive Nasal symptom relief [Time frame: From enrollment to the end of treatment at 1 week]
  • Safety endpoint [Time frame: From enrollment to the end of treatment at 1 week]

Eligibility criteria

Inclusion criteria

  • IC1. Male, female over 6 years old.
  • IC2 Rhinoscopy score of at least 6, with a dryness symptom score of at least 2.
  • IC3. Have a smartphone that can use MILO application, for any patient that wishes to answer the questionnaires on their phone.
  • IC4. Patient and/or parent/legal guardian can understand and comply with protocol requirements and instructions.
  • IC5. Patient willing to not change their daily habits including but not limited to Smoking, use of fireplace candles, air conditioning, cold air, medication and dehumidifier.
  • IC6. Signed informed consent (by patient and/or parent/legal guardian).

Exclusion criteria

  • EC1. Patients taking anticoagulants, over-the-counter or prescription systemic/topical corticosteroids, antibiotics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), leukotriene antagonists, topical or systemic decongestants or any treatment for relieve of nasal symptoms (except acetaminophen) in the two weeks prior to Visit 1 and during the study;
  • EC2. Patient with known hyper sensibility to the study treatment;
  • EC3. Patients using other nasal sprays, nasal pumps, nasal irrigation/washing devices or nasal oils, creams or gels in the two weeks prior to Visit 1 and during the study;
  • EC4. Patients with any dermatological, respiratory or medical condition (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, nasal polyposis and chronic sinusitis, urticaria or eczema) that, in the opinion of the principal investigator, could interfere with the interpretation of study results;
  • EC5. Patients with a positive medical history of any significant illness in the 2 weeks preceding the study, which, in the opinion of the principal investigator, could interfere with the interpretation of study results;
  • EC6. Patients with nasal anatomical anomalies, e.g., severely deviated septum, congenital cleft lip/palate, nasal hemorrhagic diathesis (assessed by principal investigator);
  • EC7. Patient that uses cocaine or other inhaled drugs
  • EC8. Patients with any clinically significant co-morbid condition that, in the opinion of the principal investigator, could interfere with the interpretation of study results;
  • EC9. Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial;
  • EC10. Women of childbearing age (except menopausal, hysterectomized, and sterilized) are not using effective contraception (oral contraceptives, intra-uterine devices, contraceptive implants, or condoms);
  • EC11. A person belonging to a population referred to in articles 64 (incapacitated subjects), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision) and 68 (patients in an emergency) of the MDR 2017/745.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07204158 · 2025-A00666-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗