Compliance and Usability Study Evaluating RHINIX™ Nasal Filters

NCT ID: NCT02108379

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1073 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rhinix Nasal Filters

All included will receive rhinix nasal filters

Group Type EXPERIMENTAL

Rhinix Nasal Filters

Intervention Type DEVICE

Interventions

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Rhinix Nasal Filters

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhinix ApS

UNKNOWN

Sponsor Role collaborator

Astma-Allergi Danmark

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torben Sigsgaard, Prof MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 26897304 (View on PubMed)

Other Identifiers

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00002

Identifier Type: -

Identifier Source: org_study_id