Compliance and Usability Study Evaluating RHINIX™ Nasal Filters

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

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 Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Device: Rhinix Nasal Filters

• Study Type: Interventional
• Enrollment (Actual): 1073
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rhinix Nasal Filters; All included will receive rhinix nasal filters	Device: Rhinix Nasal Filters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Rhinix ApS; Astma-Allergi Danmark
• Investigators: Principal Investigator: Torben Sigsgaard, Prof MD, Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Estimate): November 11, 2014
• Last Update Submitted That Met QC Criteria: November 10, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: 00002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No