Compliance and Usability Study Evaluating RHINIX™ Nasal Filters

Seasonal Allergic Rhinitis Clinical Trial

Official title:

An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108379
• Other study ID #: 00002
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: November 10, 2014
• Start date: May 2014
• Est. completion date: July 2014

Study information

• Verified date: March 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1073
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Device:
• Rhinix Nasal Filters

Locations

Country	Name	City	State
Denmark	Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Astma-Allergi Danmark, Rhinix ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Week 1: Correlation of use and allergy severiy	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.	One assessment at the end of the 1st week of use	No
Other	Week 2: Correlation between use and allergy severity	Week 2: To assess the correlation between symptom severity at screening and likelihood of answering that they will definitely/likely continue using the product.	One assessment at the end of the 2nd week of use	No
Other	Week 1: Perceived decrease in medication	In week 1: To assess whether use of RHINIX has led to a perceived decrease in use of medication.	One assessment after the 1st week of use	No
Other	Week 2: Perceived decrease in medication	Week 2: To assess whether use of RHINIX has led to a perceived decrease in use of medication.	One assessment after 2nd week of use	No
Primary	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.	1 assessment at the end of the 1st week of use.	No
Primary	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.	1 assessment at the end of the 2nd week of use.	No
Secondary	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.	1 assessment at the end of the 1st week	No
Secondary	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.	One assessment at the end of the 2nd week	No
Secondary	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	One assessment at the end of the 1st week of use	No
Secondary	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	One assessment at the end of the 2nd week of use.	No