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

Официальное название

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.

Обзор

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.

Вмешательства

• Устройство Spray pompe nasal confort
  Seawater solution with hyaluronan

Первичные конечные точки

• Improvement of the nasal dryness symptoms [Срок оценки: From enrollment to the end of treatment at 1 week]

Вторичные конечные точки (2)

• Improvement of the total perceive Nasal symptom relief [Срок оценки: From enrollment to the end of treatment at 1 week]
• Safety endpoint [Срок оценки: From enrollment to the end of treatment at 1 week]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07204158 · 2025-A00666-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗