Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)

Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis in a Double-blinded Randomized Placebo-controlled Crossover Pilot Study

The purpose of this study is to assess the effect of reducing exposure to allergens in patients with hay fever by means of a nasal filter.

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Seasonal
• Intervention / Treatment: Device: Placebo nasal filter; Device: Nasal filter

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study entry. Documented by a positive skin test within 12 months of study enrollment.
• Written informed consent
• Reliable anticonception for fertile women
• Must be able to complete the study
• Forced Expiratory Volume at one second (FEV1) higher than 70 % of predicted value
• Positive grass immunoglobulin-E (IgE) blood sample equal to or higher than 3,50 kU/L

Exclusion Criteria:

• Positive pregnancy test for fertile women
• Asthma unless mild and only occurring in relation to the grass pollen season as assessed by the investigator
• Inadequate washout periods in regards to Environmental Exposure Unit (EEU) 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 chronic sinusitis as determined by individual investigator
• FEV1 lower than 70 % of predicted value
• Subjects with perennial allergic rhinitis (PAR) to e.g. house dust mites, cats, dogs moulds unless symptom free
• Allergic rhinitis requiring medication caused by allergens other than grass unless symptom free
• 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 septum perforations, nasal polyps, chronic nasal obstruction or other nasal diseases
• Receipt of immunotherapy with grass pollen within the previous 10 years
• Women who are breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Placebo Nasal filter; Placebo treatment	Device: Placebo nasal filter; Placebo nasal filter
Active Comparator: Nasal Filter; Active treatment	Device: Nasal filter; Active nasal filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score	To assess the effects of active nasal filters on symptoms development in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter determined by their maximum Total Nasal Symptom Score (TNSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test.	Day 1 and day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry	To assess the effects of active nasal filters on intranasal volume in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter. The assessment will be based on the difference between minimum and maximum volume as determined by acoustic rhinometry measurements pre- and post-exposure on each study day. The statistical analysis will be a parametric paired t-test.	Day 1 and day 15

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess symptoms using a VAS Scale symptoms questionnaire (PC)	On each study day: pre-exposure and post exposure: 30 minutes post and 3 hours post	Day 1 and Day 15
To assess the tolerability and safety of nasal filters	By means of a product evaluation questionnaire. On each study day evaluated 30 minutes post exposure	Day 1 and Day 15
To assess the effects on the lower airway via nitrogen oxide measurements during expiration.	On each study day: pre-exposure, 30 minutes post exposure and 3 hours post exposure	Day 1 and Day 15
Spirometric lung function	On each study day: pre-exposure, 30 minute post exposure and in 3 hour intervals for 24 hours	Day 1 and Day 15
Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Ocular Symptom Score (TOSS)	To assess the effects of active nasal filters on symptoms development in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter determined by their maximum Total Ocular Symptom Score (TOSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test.	Day 1 and day 15

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Spirare ApS
• Investigators: Principal Investigator: Torben Sigsgaard, Professor, Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Estimate): April 19, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: adult; safety; placebo; fever; prevention; efficacy; trial; nasal; randomized; crossover; double blind; clinical; symptom; hayfever; seasonal; rhinitis; randomised; controlled; acoustic rhinometry; allergic; pollen; grass; filter; doubleblind; hay; Total nasal symptom score
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: 1202-2; CIV-12-06-007121 (Other Identifier: Danish Health and Medicines Authority); 1-10-72-371-12. (Other Identifier: The Regional Ethics Committee on Biomedical Research, Central Denmark Region)