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Compliance and Usability Study Evaluating RHINIX™ Nasal Filters

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ClinicalTrials.gov Identifier: NCT02108379
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : November 11, 2014
Sponsor:
Collaborators:
Rhinix ApS
Astma-Allergi Danmark
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Device: Rhinix Nasal Filters Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1073 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters
Study Start Date : May 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rhinix Nasal Filters
All included will receive rhinix nasal filters
Device: Rhinix Nasal Filters



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108379


Locations
Denmark
Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Rhinix ApS
Astma-Allergi Danmark
Investigators
Principal Investigator: Torben Sigsgaard, Prof MD Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02108379     History of Changes
Other Study ID Numbers: 00002
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases