Trial record 13 of 22 for:    Open Studies | "Rhinitis, Allergic, Seasonal"

Compliance and Usability Study Evaluating RHINIX™ Nasal Filters

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Aarhus
Sponsor:
Collaborators:
Rhinix ApS
Astma-Allergi Danmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02108379
First received: March 18, 2014
Last updated: May 12, 2014
Last verified: March 2014
  Purpose

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 Intervention
Seasonal Allergic Rhinitis
Device: Rhinix Nasal Filters

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Outpatient In-season Study Assessing Compliance and Usability of Rhinix™ Nasal Filters

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Week 1 likelihood of continued use of RHINIX after study end. [ Time Frame: 1 assessment at the end of the 1st week of use. ] [ Designated as safety issue: No ]
    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.

  • Week 2 likelihood of continued use of RHINIX after study end. [ Time Frame: 1 assessment at the end of the 2nd week of use. ] [ Designated as safety issue: No ]
    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:
  • Week 1 Satisfaction with RHINIX [ Time Frame: 1 assessment at the end of the 1st week ] [ Designated as safety issue: No ]
    In week 1: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.

  • Week 2 satisfaction with RHINIX [ Time Frame: One assessment at the end of the 2nd week ] [ Designated as safety issue: No ]
    In week 2: The proportion of subjects who are completely or somewhat satisfied with RHINIX given that they have used the product.

  • Week 1: RHINIX Control [ Time Frame: One assessment at the end of the 1st week of use ] [ Designated as safety issue: No ]
    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 [ Time Frame: One assessment at the end of the 2nd week of use. ] [ Designated as safety issue: No ]
    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:
  • Week 1: Correlation of use and allergy severiy [ Time Frame: One assessment at the end of the 1st week of use ] [ Designated as safety issue: No ]
    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.

  • Week 2: Correlation between use and allergy severity [ Time Frame: One assessment at the end of the 2nd week of use ] [ Designated as safety issue: No ]
    Week 2: To assess the correlation between symptom severity at screening and likelihood of answering that they will definitely/likely continue using the product.

  • Week 1: Perceived decrease in medication [ Time Frame: One assessment after the 1st week of use ] [ Designated as safety issue: No ]
    In week 1: To assess whether use of RHINIX has led to a perceived decrease in use of medication.

  • Week 2: Perceived decrease in medication [ Time Frame: One assessment after 2nd week of use ] [ Designated as safety issue: No ]
    Week 2: To assess whether use of RHINIX has led to a perceived decrease in use of medication.


Estimated Enrollment: 1500
Study Start Date: May 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rhinix Nasal Filters
All included will receive rhinix nasal filters
Device: Rhinix Nasal Filters

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02108379

Contacts
Contact: Torben Sigsgaard, Prof MD +4587168013 ts@mil.au.dk
Contact: Peter S. Kenney, MD-PHD student +4561719898 ptkh@mil.au.dk

Locations
Denmark
Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine Recruiting
Aarhus, Denmark, 8000
Contact: Peter Kenney       ptkh@mil.au.dk   
Principal Investigator: Torben Sigsgaard, Prof MD         
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02108379     History of Changes
Other Study ID Numbers: 00002
Study First Received: March 18, 2014
Last Updated: May 12, 2014
Health Authority: Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on September 22, 2014