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

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699165
• Other study ID #: 1202-2
• Secondary ID: CIV-12-06-007121
• Status: Completed
• Phase: N/A
• First received: August 16, 2012
• Last updated: April 18, 2013
• Start date: December 2012
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal

Intervention

Device:
• Nasal filter
Active nasal filter
• Placebo nasal filter
Placebo nasal filter

Locations

Country	Name	City	State
Denmark	Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Spirare ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	Yes
Other	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	Yes
Other	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	Yes
Other	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	No
Primary	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	No
Secondary	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	No