Clinical Evaluation of the Efficacy of a Nasal Spray in t... | NCT07657247

NCT07657247

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Eurofins	INDUSTRY

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Nasal spray	Experimental		Device: Spray pompe nasal

Name	Type	Description	Arm Group Labels	Other Names
Spray pompe nasal	Device	Dosage: 2 sprays per nostril	Nasal spray

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of the nasal dryness symptoms	The changes between the baseline and day 7 will be assessed using the Rhinitis Sicca Symptom Score (RSSS). The RSSS is constituted by the sum of the following individual symptoms: sensation of dry nose, impairment of nasal breathing/nasal obstruction, crusting, itching/sneezing attacks, pain in the nose, anterior nasal discharge /runny nose, thick nasal discharge, desire to clear one's throat/ dry throat, impairment of smell and impairment of sleep. Patients assessed with each of these symptoms on an ordinal scale of 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = strong, 4 = very strong).	Day 0 - Day 0 immediately after first use - Day 7

Secondary Outcomes

Measure	Description	Time Frame
Improvement of the total perceive Nasal symptom relief	The changes between the baseline and day 7 in the rhinoscopy score will be assessed. The rhinoscopy score is constituted by the sum of the following symptom: dryness, atrophy, redness, oedema of the nasal mucosa and crusting. The clinician will assess each symptom on an ordinal scale of 0-4 (0 = none, 1 = mild, 2 = moderate, 3 = strong, 4 = very strong).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gender: female and/or male.
Age: adults and children from 6 years old:
The physician's score for at least two symptoms, in addition to a dry nose, must average at least 2 at the enrolment visit (Day 0), for a minimum total score of 6.
Subjects agree to refrain from taking any medication and/or taking any action to relieve nasal symptoms throughout the study, from Day -4 to Day 7, apart from acetaminophen.
Autonomous adult, or minor with the consent of their legal representative.
Subject and/or Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
Subject and/or Parent/legal guardian is cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol established by the clinical trial center could be expected.
Ability of the patient (for adults) or their legal representative (for children) to follow the instructions for product use.
Having signed a free and informed consent to participate in the study expressed by the patient (for adults) or by their legal representative (for children) after being informed by the doctor.

Exclusion Criteria:

Subjects taking anticoagulants, antihistamines, nonsteroidal anti-inflammatory drugs (NSAIDs), or topical or systemic decongestants within two weeks prior to Visit 1 and during the study.
Subjects using other nasal sprays, nasal pumps, nasal irrigation/rinsing devices, or oils, creams, or gels in the nose within two weeks prior to Visit 1 and during the study.
Subjects with a history of sensitivity to products related to the product being evaluated.
Subjects with any clinically significant comorbid condition that, in the opinion of the principal investigator, could affect the subject's safety and/or participation in the study.
Person whose ability to use the product daily and complete the daily follow-up diary is in doubt.
Person refusing to sign the informed consent form prior to the study.
Person participating or having participated in any other clinical study within the 30 days preceding the study.
Person participating in any other clinical study.