Rhinitis, Allergic, Seasonal
Conditions
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
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.
Interventions
DEVICENasal filter
Active nasal filter
DEVICEPlacebo nasal filter
Placebo nasal filter
Sponsors
Spirare ApS
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score | Day 1 and day 15 | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry | Day 1 and day 15 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To assess the effects on the lower airway via nitrogen oxide measurements during expiration. | Day 1 and Day 15 | On each study day: pre-exposure, 30 minutes post exposure and 3 hours post exposure |
| To assess symptoms using a VAS Scale symptoms questionnaire (PC) | Day 1 and Day 15 | On each study day: pre-exposure and post exposure: 30 minutes post and 3 hours post |
| 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) | Day 1 and day 15 | 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. |
| Spirometric lung function | Day 1 and Day 15 | On each study day: pre-exposure, 30 minute post exposure and in 3 hour intervals for 24 hours |
| To assess the tolerability and safety of nasal filters | Day 1 and Day 15 | By means of a product evaluation questionnaire. On each study day evaluated 30 minutes post exposure |
Countries
Denmark
Outcome results
None listed