Clinical trial NCT05264350: A Post-Market Clinical Follow-up Investigation to Verify Performance and Safety of Viiral®Nasal Spray in Subjects With Dry Nose Symptoms
Official title: A Prospective, Multicenter, Randomized, Controlled, Blinded Post-Market Clinical Follow-up Investigation to Verify Clinical Efficacy, Performance, and Safety of Viiral® Nasal Spray, Compared to Control, When Used According to Intended Use in Subjects With Dry Nose Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinitis Sicca
Lead sponsor: Viiral Nordic AB
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomised in proportions 2:1, Viiral® Nasal Spray group: Isotonic Saline Nasal Spray group. Block randomisation will be performed with varying block sizes. Numbered randomisation envelopes containing cards with code numbers will be prepared.
Primary purpose: TREATMENT

Brief summary: A chronic irritation of the nasal mucosa can be painful and unpleasant for the individual. Dry nasal mucosa with scabs is a common problem but not everyone seeks care. The causes can be several such as staying for long periods in dry and dusty air, hot rooms or hot environments, tobacco smoke, side effects of drugs and mechanical irritation (nasal congestion). The nasal spray contains salic acid (neuraminic acid). This substance is found naturally in humans in the nasal mucosa which keeps it moist. Salic acid is also found, for example, in breast milk and is also found in food production. Previous studies have shown that treatment with salic acid is gentle, relieves symptoms and has a soothing and moisturising effect.

The purpose of the study is to evaluate whether the symptoms of dry nose can be improved with treatment with Viiral®Nasal spray and have a soothing and moisturising effect. The treatment also aims to prevent colds caused by viruses.

As a control product in the study, a nasal spray with isotonic saline solution will be used. In this study, a total of 78 women and men who have been diagnosed with dry nose / rhinitis sicca will be included in the study. After the participants have given their consent to participate in the study, treatment with the study product or control product will begin. The treatment is started by the study participants themselves at home. Two thirds will be treated with the study product and one third will be treated with a control product. Clinic visits will be performed at three occasions after the screening/baseline visit, at day 14, day 28 and on day 56.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form.
* Adult males and females ≥ 18 years old.
* Score of at least 10 as indication for application of moistening nasal sprays per investigator judgement, confirmed with a total Rhinitis Sicca Symptom Score (sensation of dry nose, nasal obstruction, crusting, itching/sneezing attacks, pain in the nose, runny nose, thick nasal discharge, dry throat, impairment of smell and impairment of sleep) using a 5-point severity scale (0=none, 1=mild, 2=moderate, 3=strong, and 4 = very strong.
* Able to use the device independently.

Exclusion Criteria:

* Antiallergy drugs and rhinitis medication, including rescue medication for symptom relief and anti-hyperactivity last week.
* Pregnancy or lactation at time of investigation participation.
* Physical or mental impairment affecting subjects' ability to use the device, per investigator judgement.
* Person not suitable for the investigation according to the investigator judgement.

Primary outcomes:
measure: Rhinitis Sicca Symptom Score (RSSS)
timeFrame: Up to 8 weeks.
Secondary outcomes:
measure: Nasal spray sensory scale (NSSS)
timeFrame: Up to 8 weeks.
measure: Short Form 12 (SF-12)
timeFrame: Up to 8 weeks.
measure: Endoscopy score of the nasal cavity (ES)
timeFrame: Up to 8 weeks.
measure: Episodes of common cold/sick days
timeFrame: Up to 8 weeks.
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Universitetssjukhuset, Avdelning för kliniska prövningar
state: Region Örebro
city: Linköping
country: Sweden
facility: Cordinator Medical Service AB
state: Region Östergötland
Study officials:
References: