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Completed

NCT Number: NCT05264350

A Post-Market Clinical Follow-up Investigation to Verify Performance and Safety of Viiral®Nasal Spray 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.

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Key information

Conditions

Rhinitis Sicca

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitetssjukhuset, Avdelning för kliniska prövningar, Örebro, Region Örebro, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sialic acid nasal spray

Device

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

Isotonic Saline Nasal Spray

Device

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

Primary outcomes

  1. Rhinitis Sicca Symptom Score (RSSS)

    Time frame: Up to 8 weeks.

    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

Secondary outcomes

  1. Nasal spray sensory scale (NSSS)

    Time frame: Up to 8 weeks.

    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?

  2. Short Form 12 (SF-12)

    Time frame: Up to 8 weeks.

    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.

  3. Endoscopy score of the nasal cavity (ES)

    Time frame: Up to 8 weeks.

    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

  4. Episodes of common cold/sick days

    Time frame: Up to 8 weeks.

    The total number of common cold episodes and episodes days.

Sponsors and collaborators

Lead sponsor

Viiral Nordic AB

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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