Compliance and Usability Study Evaluating RHINIX™ Nasal Filters

Not Applicable

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Device: Rhinix Nasal Filters

• Registration Number: NCT02108379
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-09
• Study Start: 2014-05
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-11-10
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1073

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

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Exclusion Criteria

• Improper fit of the Rhinix™ device

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rhinix Nasal Filters	Rhinix Nasal Filters	All included will receive rhinix nasal filters

Primary Outcome Measures

Name	Time	Method
Week 2 likelihood of continued use of RHINIX after study end.	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.	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 Outcome Measures

Name	Time	Method
Week 1: RHINIX Control	One assessment at the end of the 1st week of use	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	One assessment at the end of the 2nd week of use.	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
Week 2 satisfaction with RHINIX	One assessment at the end of the 2nd week	In week 2: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.
Week 1 Satisfaction with RHINIX	1 assessment at the end of the 1st week	In week 1: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.

Trial Locations

Locations (1)

Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine; 🇩🇰 Aarhus, Denmark