Status:
COMPLETED
A Post-Market Clinical Follow-up Investigation to Verify Performance and Safety of Viiral®Nasal Spray in Subjects With Dry Nose Symptoms
Lead Sponsor:
Viiral Nordic AB
Conditions:
Rhinitis Sicca
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2022
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05264350
Start Date
February 3 2022
End Date
September 15 2022
Last Update
October 13 2022
Active Locations (2)
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1
Universitetssjukhuset, Avdelning för kliniska prövningar
Örebro, Region Örebro, Sweden, 701 85
2
Cordinator Medical Service AB
Linköping, Region Östergötland, Sweden, 58 758