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

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

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis Sicca
• Intervention / Treatment: Device: Sialic acid nasal spray; Device: Isotonic Saline Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Region Örebro
    • Örebro, Region Örebro, Sweden, 701 85
      • Universitetssjukhuset, Avdelning för kliniska prövningar
  • Region Östergötland
    • Linköping, Region Östergötland, Sweden, 58 758
      • Cordinator Medical Service AB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Viiral® Nasal Spray group; The nasal spray to be administrated twice daily for 8 weeks.	Device: Sialic acid nasal spray; The nasal spray will be self administered twice daily for 8 weeks.
Active Comparator: Isotonic Saline Nasal Spray; The nasal spray to be administrated twice daily for 8 weeks.	Device: Isotonic Saline Nasal Spray; The nasal spray will be self administered twice daily for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).; Sensation of dry nose; Impairment of nasal breathing/nasal obstruction; Crusting; Itching/ sneezing attacks; Pain in the nose; Nasal discharge anterior/runny nose; Thick nasal discharge; Desire to clear one's throat /dry throat; Impairment of smell; Impairment of sleep	Up to 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal spray sensory scale (NSSS)	Tolerability examination, sensory perception of the spray. Parameters to be answered using visual analog scale (VAS 0 = worst grading - 100 = best grading); Did product have any taste?; Did product run out of nose? (amount); Did product run down throat? (amount); Did you feel discomfort when nozzle was inserted to your nose?; Did product induce the urgency to sneeze?	Up to 8 weeks.
Short Form 12 (SF-12)	SF-12 is a health-related quality of life questionnaire consisting of twelve questions that measure functional health and well-being form the subject's point of view.	Up to 8 weeks.
Endoscopy score of the nasal cavity (ES)	Changes of the nasal mucosa using a 3-point scale (0 = no, 1 = mild, 2 = severe).; Classification of crusting; Dryness of mucosa; Redness and oedema of nasal mucosa; Atrophy	Up to 8 weeks.
Episodes of common cold/sick days	The total number of common cold episodes and episodes days.	Up to 8 weeks.

Collaborators and Investigators

• Sponsor: Viiral Nordic AB

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: Vii-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No