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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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| Name | Class |
|---|---|
| Spirare ApS | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Nasal filter | Sham Comparator | Placebo treatment |
|
| Nasal Filter | Active Comparator | Active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal filter | Device | Active nasal filter |
| |
| Placebo nasal filter |
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torben Sigsgaard, Professor | Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D012220 | Rhinitis |
| D005334 | Fever |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Device |
Placebo nasal filter |
|
| Day 1 and day 15 |
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 |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |