Back to resultsCompliance and Usability Study Evaluating RHINIX™ Nasal Filters
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Rhinix Nasal Filters
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
Eligibility Criteria
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
Sites / Locations
- Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rhinix Nasal Filters
Arm Description
All included will receive rhinix nasal filters
Outcomes
Primary Outcome Measures
Week 1 likelihood of continued use of RHINIX after study end.
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.
Week 2 likelihood of continued use of RHINIX after study end.
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.
Secondary Outcome Measures
Week 1 Satisfaction with RHINIX
In week 1: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.
Week 2 satisfaction with RHINIX
In week 2: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.
Week 1: RHINIX Control
In week 1: The proportion of subjects who state that RHINIX has helped "to a very high degree" or "to a high degree" in controlling their hay fever symptoms given that they have used the product
Week 2: RHINIX Control
In week 2: The proportion of subjects who state that RHINIX has helped "to a very high degree" or "to a high degree" in controlling their hay fever symptoms given that they have used the product
Full Information
NCT ID
NCT02108379
First Posted
March 18, 2014
Last Updated
November 10, 2014
Sponsor
University of Aarhus
Collaborators
Rhinix ApS, Astma-Allergi Danmark
1. Study Identification
Unique Protocol Identification Number
NCT02108379
Brief Title
Compliance and Usability Study Evaluating RHINIX™ Nasal Filters
Official Title
An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Rhinix ApS, Astma-Allergi Danmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1073 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rhinix Nasal Filters
Arm Type
Experimental
Arm Description
All included will receive rhinix nasal filters
Intervention Type
Device
Intervention Name(s)
Rhinix Nasal Filters
Primary Outcome Measure Information:
Title
Week 1 likelihood of continued use of RHINIX after study end.
Description
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.
Time Frame
1 assessment at the end of the 1st week of use.
Title
Week 2 likelihood of continued use of RHINIX after study end.
Description
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.
Time Frame
1 assessment at the end of the 2nd week of use.
Secondary Outcome Measure Information:
Title
Week 1 Satisfaction with RHINIX
Description
In week 1: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.
Time Frame
1 assessment at the end of the 1st week
Title
Week 2 satisfaction with RHINIX
Description
In week 2: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.
Time Frame
One assessment at the end of the 2nd week
Title
Week 1: RHINIX Control
Description
In week 1: The proportion of subjects who state that RHINIX has helped "to a very high degree" or "to a high degree" in controlling their hay fever symptoms given that they have used the product
Time Frame
One assessment at the end of the 1st week of use
Title
Week 2: RHINIX Control
Description
In week 2: The proportion of subjects who state that RHINIX has helped "to a very high degree" or "to a high degree" in controlling their hay fever symptoms given that they have used the product
Time Frame
One assessment at the end of the 2nd week of use.
Other Pre-specified Outcome Measures:
Title
Week 1: Correlation of use and allergy severiy
Description
In week 1: To assess the correlation between symptom severity at screening and likelihood of answering that they will definitely/likely continue using the product.
Time Frame
One assessment at the end of the 1st week of use
Title
Week 2: Correlation between use and allergy severity
Description
Week 2: To assess the correlation between symptom severity at screening and likelihood of answering that they will definitely/likely continue using the product.
Time Frame
One assessment at the end of the 2nd week of use
Title
Week 1: Perceived decrease in medication
Description
In week 1: To assess whether use of RHINIX has led to a perceived decrease in use of medication.
Time Frame
One assessment after the 1st week of use
Title
Week 2: Perceived decrease in medication
Description
Week 2: To assess whether use of RHINIX has led to a perceived decrease in use of medication.
Time Frame
One assessment after 2nd week of use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben Sigsgaard, Prof MD
Organizational Affiliation
Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
26897304
Citation
Kenney P, Hilberg O, Sigsgaard T. Clinical Application of Nasal Filters: An Observational Study on the Usability of Nasal Filters in Managing Seasonal Allergic Rhinitis. J Allergy Clin Immunol Pract. 2016 May-Jun;4(3):445-452.e4. doi: 10.1016/j.jaip.2016.01.003. Epub 2016 Feb 18.
Results Reference
derived
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Compliance and Usability Study Evaluating RHINIX™ Nasal Filters
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