Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

University of Aarhus

Status: Completed

Conditions: Seasonal Allergic Rhinitis

Treatments: Device: Placebo Filter; Device: Rhinix Nasal Filter

Study type: Interventional

Funder types: Other

Identifiers

NCT02108574

1401

Details and patient eligibility

About

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

Full description

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups, including a placebo group

Placebo Filter

Placebo Comparator group

Description:

Placebo device

Treatment:

Device: Placebo Filter

Rhinix Nasal Filter

Active Comparator group

Description:

Actual Rhinix Nasal Filter

Treatment:

Device: Rhinix Nasal Filter