NCT01699165已完成不适用
Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis in a Double-blinded Randomized Placebo-controlled Crossover Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score
时间窗: 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.
次要结局
- Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry(Day 1 and day 15)
研究者
研究点 (2)
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