A Post-Market Clinical Follow-up Investigation to Verify Performance and Safety of Viiral®Nasal Spray in Subjects With Dry Nose Symptoms

NCT05264350 | Completed

• 1 other identifier: Vii-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Rhinitis Sicca

Outcome Measures

Primary Outcomes (1)

• Rhinitis Sicca Symptom Score (RSSS)

  RSSS score constitutes of the sum of ten (10) individual symptoms. Each symptom assessed on 5-point scale (0 = none, 1 = mild, 2 = moderated, 3 = strong, 4 = very strong). 1. Sensation of dry nose 2. Impairment of nasal breathing/nasal obstruction 3. Crusting 4. Itching/ sneezing attacks 5. Pain in the nose 6. Nasal discharge anterior/runny nose 7. Thick nasal discharge 8. Desire to clear one's throat /dry throat 9. Impairment of smell 10. Impairment of sleep

  Up to 8 weeks.

Secondary Outcomes (4)

• Nasal spray sensory scale (NSSS)

  Up to 8 weeks.

• Short Form 12 (SF-12)

  Up to 8 weeks.

• Endoscopy score of the nasal cavity (ES)

  Up to 8 weeks.

• Episodes of common cold/sick days

  Up to 8 weeks.

Study Arms (2)

Viiral® Nasal Spray group

EXPERIMENTAL

The nasal spray to be administrated twice daily for 8 weeks.

Device: Sialic acid nasal spray

Isotonic Saline Nasal Spray

ACTIVE COMPARATOR

The nasal spray to be administrated twice daily for 8 weeks.

Device: Isotonic Saline Nasal Spray

Interventions

Sialic acid nasal spray DEVICE

The nasal spray will be self administered twice daily for 8 weeks.

Viiral® Nasal Spray group

Isotonic Saline Nasal Spray DEVICE

The nasal spray will be self administered twice daily for 8 weeks.

Isotonic Saline Nasal Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viiral Nordic AB: lead

Study Sites (2)

Universitetssjukhuset, Avdelning för kliniska prövningar

Örebro, Region Örebro, 701 85, Sweden

Location

Cordinator Medical Service AB

Linköping, Region Östergötland, 58 758, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: March 3, 2022
• Study Start: February 3, 2022
• Primary Completion: August 16, 2022
• Study Completion: September 15, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

SE (2)