Skip to main content
OpenTrials
Completed

NCT Number: NCT02108379

Compliance and Usability Study Evaluating 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhinix Nasal Filters

Device

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Week 1 Satisfaction with RHINIX

    Time frame: 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.

  2. Week 2 satisfaction with RHINIX

    Time frame: 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.

  3. Week 1: RHINIX Control

    Time frame: 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

  4. Week 2: RHINIX Control

    Time frame: 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

Other outcomes

  1. Week 1: Correlation of use and allergy severiy

    Time frame: One assessment at the end of the 1st week of use

    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.

  2. Week 2: Correlation between use and allergy severity

    Time frame: One assessment at the end of the 2nd week of use

    Week 2: To assess the correlation between symptom severity at screening and likelihood of answering that they will definitely/likely continue using the product.

  3. Week 1: Perceived decrease in medication

    Time frame: One assessment after the 1st week of use

    In week 1: To assess whether use of RHINIX has led to a perceived decrease in use of medication.

  4. Week 2: Perceived decrease in medication

    Time frame: One assessment after 2nd week of use

    Week 2: To assess whether use of RHINIX has led to a perceived decrease in use of medication.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Astma-Allergi Danmark
  • Rhinix ApS

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.