Back to resultsEfficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Nasal filter
Placebo nasal filter
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring rhinitis, allergic, seasonal, double blind, doubleblind, randomized, randomised, placebo, crossover, clinical, nasal, filter, controlled, trial, hayfever, hay, fever, efficacy, safety, prevention, adult, grass, pollen, symptom, Total nasal symptom score, acoustic rhinometry
Eligibility Criteria
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
Sites / Locations
- Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Placebo Nasal filter
Nasal Filter
Arm Description
Placebo treatment
Active treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01699165
First Posted
August 16, 2012
Last Updated
April 18, 2013
Sponsor
University of Aarhus
Collaborators
Spirare ApS
1. Study Identification
Unique Protocol Identification Number
NCT01699165
Brief Title
Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)
Official Title
Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis in a Double-blinded Randomized Placebo-controlled Crossover Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Spirare ApS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
rhinitis, allergic, seasonal, double blind, doubleblind, randomized, randomised, placebo, crossover, clinical, nasal, filter, controlled, trial, hayfever, hay, fever, efficacy, safety, prevention, adult, grass, pollen, symptom, Total nasal symptom score, acoustic rhinometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Nasal filter
Arm Type
Sham Comparator
Arm Description
Placebo treatment
Arm Title
Nasal Filter
Arm Type
Active Comparator
Arm Description
Active treatment
Intervention Type
Device
Intervention Name(s)
Nasal filter
Intervention Description
Active nasal filter
Intervention Type
Device
Intervention Name(s)
Placebo nasal filter
Intervention Description
Placebo nasal filter
Primary Outcome Measure Information:
Title
Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score
Description
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.
Time Frame
Day 1 and day 15
Secondary Outcome Measure Information:
Title
Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry
Description
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.
Time Frame
Day 1 and day 15
Other Pre-specified Outcome Measures:
Title
To assess symptoms using a VAS Scale symptoms questionnaire (PC)
Description
On each study day: pre-exposure and post exposure: 30 minutes post and 3 hours post
Time Frame
Day 1 and Day 15
Title
To assess the tolerability and safety of nasal filters
Description
By means of a product evaluation questionnaire. On each study day evaluated 30 minutes post exposure
Time Frame
Day 1 and Day 15
Title
To assess the effects on the lower airway via nitrogen oxide measurements during expiration.
Description
On each study day: pre-exposure, 30 minutes post exposure and 3 hours post exposure
Time Frame
Day 1 and Day 15
Title
Spirometric lung function
Description
On each study day: pre-exposure, 30 minute post exposure and in 3 hour intervals for 24 hours
Time Frame
Day 1 and Day 15
Title
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)
Description
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.
Time Frame
Day 1 and day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben Sigsgaard, Professor
Organizational Affiliation
Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)
We'll reach out to this number within 24 hrs