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Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

NCT ID: NCT02108574

Last Updated: 2014-12-23

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

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

Brief Summary

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This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis (hay fever) in a park setting.

Detailed Description

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The study will include 100 participants with grass allergy and will look at the efficacy and usability of RHINIX™ nasal filters on hay fever in a randomized, double-blind, placebo-controlled, crossover design.

Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Filter

Placebo device

Group Type PLACEBO_COMPARATOR

Placebo Filter

Intervention Type DEVICE

Rhinix Nasal Filter

Actual Rhinix Nasal Filter

Group Type ACTIVE_COMPARATOR

Rhinix Nasal Filter

Intervention Type DEVICE

Interventions

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Placebo Filter

Intervention Type DEVICE

Rhinix Nasal Filter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study entry. Documented by a positive skin test (wheal \> 3mm) within 12 months of study enrolment.
* Written informed consent
* Must be able to complete the study
* Reliable anticonception for fertile women
* FEV1 higher than 70 % of predicted value
* Positive grass IgE blood sample higher or equal to 0,7 kU/L

Exclusion Criteria

* Improper fit of the Rhinix™ device
* Nasal septal deviation
* Retrospective TNSS for last summer \< 3
* Positive pregnancy test for fertile women
* Inadequate washout periods in regards to park study appointments (intranasal or systemic corticosteroids (1month), intranasal cromolyn (2 weeks), intranasal or systemic decongestants (3 days), intranasal or systemic antihistamines (3 days), Loratadine (10 days)).
* Rhinitis medicamentosa
* Use of long acting anti-histamines.
* Documented evidence of acute or cronic sinusitis, as determined by the individual investigator.
* FEV1 lower than 70 % of predicted value
* Subjects with nasal conditions likely to affect the outcome of the study in the opinion of the investigator, i.e. anterior nasal septum deviation, nasal septal perforations, nasal polyps, chronic nasal obstruction or other nasal diseases.
* Receipt of immunotherapy with grass pollen within the previous 10 years (at least two rounds of treatment).
* Women who are breastfeeding
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

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torben Sigsgaard, Professor

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 C, , Denmark

Site Status

Countries

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Denmark

References

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Kenney P, Hilberg O, Laursen AC, Peel RG, Sigsgaard T. Preventive effect of nasal filters on allergic rhinitis: A randomized, double-blind, placebo-controlled crossover park study. J Allergy Clin Immunol. 2015 Dec;136(6):1566-1572.e5. doi: 10.1016/j.jaci.2015.05.015. Epub 2015 Jun 30.

Reference Type DERIVED
PMID: 26141263 (View on PubMed)

Other Identifiers

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1401

Identifier Type: -

Identifier Source: org_study_id