An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 1,073
- Locations
- 1
- Primary Endpoint
- Week 2 likelihood of continued use of RHINIX after study end.
Study Overview
Brief Summary
This study will investigate usability and compliance related to rhinix nasal filters for the treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in Denmark.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Motivated to try a different treatment approach to seasonal allergic rhinitis (documented by answering the call-out by Astma-Allergi Danmark)
- •Indicates having seasonal allergic rhinitis to grass via online questionnaire
- •Informed consent (by email acceptance after having received information on the trial)
- •Assess to internet and email
Exclusion Criteria
- •Improper fit of the Rhinix™ device
Arms & Interventions
Rhinix Nasal Filters
All included will receive rhinix nasal filters
Intervention: Rhinix Nasal Filters (Device)
Outcomes
Primary Outcomes
Week 2 likelihood of continued use of RHINIX after study end.
Time Frame: 1 assessment at the end of the 2nd week of use.
In week 2: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device.
Week 1 likelihood of continued use of RHINIX after study end.
Time Frame: 1 assessment at the end of the 1st week of use.
In week 1: The proportion of subjects that rate that they will definitely or are likely to continue using RHINIX after the study is over given that they have stated that they have tried the device.
Secondary Outcomes
- Week 1: RHINIX Control(One assessment at the end of the 1st week of use)
- Week 2: RHINIX Control(One assessment at the end of the 2nd week of use.)
- Week 2 satisfaction with RHINIX(One assessment at the end of the 2nd week)
- Week 1 Satisfaction with RHINIX(1 assessment at the end of the 1st week)