NCT02108379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,073

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 11, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

March 18, 2014

Last Update Submit

November 10, 2014

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Week 1 Satisfaction with RHINIX

    1 assessment at the end of the 1st week

  • Week 2 satisfaction with RHINIX

    One assessment at the end of the 2nd week

  • Week 1: RHINIX Control

    One assessment at the end of the 1st week of use

  • Week 2: RHINIX Control

    One assessment at the end of the 2nd week of use.

Other Outcomes (4)

  • Week 1: Correlation of use and allergy severiy

    One assessment at the end of the 1st week of use

  • Week 2: Correlation between use and allergy severity

    One assessment at the end of the 2nd week of use

  • Week 1: Perceived decrease in medication

    One assessment after the 1st week of use

  • +1 more other outcomes

Study Arms (1)

Rhinix Nasal Filters

EXPERIMENTAL

All included will receive rhinix nasal filters

Device: Rhinix Nasal Filters

Interventions

Rhinix Nasal FiltersDEVICE
Rhinix Nasal Filters

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Improper fit of the Rhinix™ device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26897304DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Torben Sigsgaard, Prof MD

    Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

April 9, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 11, 2014

Record last verified: 2014-03

Locations

DK(1)