Clinical trial NCT01699165: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Spirare ApS
First posted: 2012-10-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score
timeFrame: Day 1 and day 15
Secondary outcomes:
measure: Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry
timeFrame: Day 1 and day 15
Other outcomes:
measure: To assess symptoms using a VAS Scale symptoms questionnaire (PC)
timeFrame: Day 1 and Day 15
measure: To assess the tolerability and safety of nasal filters
timeFrame: Day 1 and Day 15
measure: To assess the effects on the lower airway via nitrogen oxide measurements during expiration.
timeFrame: Day 1 and Day 15
measure: Spirometric lung function
timeFrame: Day 1 and Day 15
measure: 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)
timeFrame: Day 1 and day 15
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Study officials:
affiliation: Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
name: Torben Sigsgaard, Professor
role: PRINCIPAL_INVESTIGATOR
References: