Rhinitis SiccaNCT05264350
A Post-Market Clinical Follow-up Investigation to Verify Performance and Safety of Viiral®Nasal Spray in Subjects With Dry Nose Symptoms
A study testing Sialic acid nasal spray and Isotonic Saline Nasal Spray in people with Rhinitis Sicca, run by Viiral Nordic AB at 2 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis Sicca
- What is being tested?
- Sialic acid nasal spray and Isotonic Saline Nasal Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesSweden
- Study dates
- 3 Feb 2022to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Cordinator Medical Service AB
Linköping, Region Östergötland, 58 758
Universitetssjukhuset, Avdelning för kliniska prövningar
Örebro, Region Örebro, 701 85
About this study
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
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
- Being tested
- Sialic acid nasal spray, Isotonic Saline Nasal Spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sialic acid nasal sprayDevice
The nasal spray will be self administered twice daily for 8 weeks.
Isotonic Saline Nasal SprayDevice
The nasal spray will be self administered twice daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Viiral® Nasal Spray group | Experimental | The nasal spray to be administrated twice daily for 8 weeks. Receives: Device: Sialic acid nasal spray |
| Isotonic Saline Nasal Spray | Active comparator | The nasal spray to be administrated twice daily for 8 weeks. Receives: Device: Isotonic Saline Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 8 weeks.
Secondary outcomes (4)
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?
Measured: 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.
Measured: 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
Measured: Up to 8 weeks.
Episodes of common cold/sick days
The total number of common cold episodes and episodes days.
Measured: Up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start3 Feb 2022
- Primary completion16 Aug 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis SiccaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viiral Nordic AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264350
- Sponsor's protocol ID
- Vii-001
- Status last verified
- Oct 2022
- First submitted
- 3 Feb 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05264350
- Acronym / sponsor ID
- Vii-001
- Conditions
- Rhinitis Sicca
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Viiral Nordic ABIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Viiral® Nasal Spray group | Experimental | Device: Sialic acid nasal sprayThe nasal spray to be administrated twice daily for 8 weeks. |
| Isotonic Saline Nasal Spray | Active comparator | Device: Isotonic Saline Nasal SprayThe nasal spray to be administrated twice daily for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sialic acid nasal sprayThe nasal spray will be self administered twice daily for 8 weeks. | Device | Viiral® Nasal Spray group |
| Isotonic Saline Nasal SprayThe nasal spray will be self administered twice daily for 8 weeks. | Device | Isotonic Saline Nasal Spray |
Primary outcome
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). 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
4 secondary outcomes
Nasal spray sensory scale (NSSS)
Time frame: Up to 8 weeks.
Short Form 12 (SF-12)
Time frame: Up to 8 weeks.
Endoscopy score of the nasal cavity (ES)
Time frame: Up to 8 weeks.
Episodes of common cold/sick days
Time frame: Up to 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Rhinitis Sicca
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sialic acid nasal spray and Isotonic Saline Nasal Spray in people with Rhinitis Sicca, run by Viiral Nordic AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhinitis Sicca Symptom Score (RSSS) (time frame: Up to 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.