Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever

NCT02108574 | Completed DMC

• 1 other identifier: 1401
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• To assess the change in daily Total Nasal Symptom Score (TNSS) between Rhinix™ and placebo

  Baseline recording at 09.00 Run-in recordings from 09.30-11.00 Daily Total Nasal Symptom Score evaluated from 11.00-17.00 with the last recording at 17.00, recordings at 30 minute increments. Total Nasal Symptom Score is the sum of 4 symptoms (runny nose, blocked nose, itchy nose and sneezing) which are each evaluated on a scale of 0=none, 1=mild, 2=moderate, 3=severe symptoms

  11.00-17.00 with recordings at 30. minute increments.

Secondary Outcomes (3)

• To assess the change in Daily Throat Irritation between Rhinix™ and placebo

  11.00-17.00 with hourly increments

• To assess the correlation between maximum TNSS and difference in Daily TNSS

  11.00-17.00 at 30 minute increments

• Change in Daily TNSS for subgroup

  11.00-17.00 at 30 minute increments

Study Arms (2)

Placebo Filter

PLACEBO COMPARATOR

Placebo device

Device: Placebo Filter

Rhinix Nasal Filter

ACTIVE COMPARATOR

Actual Rhinix Nasal Filter

Device: Rhinix Nasal Filter

Interventions

Placebo Filter DEVICE

Placebo Filter

Rhinix Nasal Filter DEVICE

Rhinix Nasal Filter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Rhinix ApS: collaborator

Study Sites (1)

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

Aarhus C, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 26141263 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Torben Sigsgaard, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

DK (1)