NCT01997606已完成不适用
Cross-over Study of the Impact of Purotex Covers on the Concentration of House Dust Mite Allergen in Bedding and the Quality of Life in Patients With Allergic Rhinitis to House Dust Mite.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in house dust mite allergen concentration
研究概览
简要总结
Product information:
Purotex is a textile treatment that uses five 100% natural bacteria or probiotics, selected for their ability to clean up house dust mite allergen along with other allergen types.
Study design:
- Placebo-controlled: the effect of the Purotex impregnated mattress and pillow covers will be compared to untreated, classical bedding covers (placebo).
- Cross-over design: There will be 2 'treatment' arms. One arm (Arm 1) in which the subjects will first use the Purotex impregnated covers (Set A=Purotex) during 2 months (=period A) and, after a wash out period of 1 month, the untreated covers (set B=placebo) during 2 months (=period B). In the second arm (Arm 2), the subjects will first use the untreated set (set A=placebo) and, after a wash out period the Purotex impregnated covers (set B=Purotex).
- Randomized: The subjects will be randomly assigned to one of the 2 treatment arms.
- Double blind: both the subjects and the investigators will not know to which treatment arm the subjects are assigned.
Study hypothesis:
We want to investigate:
- if there is a reduced concentration of HDM allergen in Purotex covers compared to untreated covers in real life
- if patients with allergic rhinitis to house dust mite use the Purotex covers, they experience an improvement of their quality of life and sleep, and an improvement of their allergic symptoms and global discomfort
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, 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
- •Subjects must be willing to give/sign informed consent
- •Subjects (male or female) must be at least 18 years old and maximum 65 years old at screening
- •Clinical history of allergic rhinitis for at least 1 year
- •Positive skin prick test for D. Pteronyssinus ± D. Farinae
- •Positive nasal provocation test with the house-dust-mite allergen
- •Specific IgE: Unicap positive to D. Pteronyssinus (d1) and D. Farinae (d2) (> 0.7U/ml)
- •VAS score for global discomfort caused by nasal- or other allergic symptoms during the previous 4 weeks ≥
- •The concentration of Der p1 in the dust collected from own bedding (mattress and pillow), measured by ELISA is above the detection limit (≥ 0.488 ng/ml).
排除标准
- •Patients sensitized to animals should not be included if they are symptomatic upon exposure and regularly exposed to animals: positive SPT to pets and pets at home
- •Patients with an allergy to tree pollen (symptoms during the season + positive skin prick test) should not be included
- •Subject pregnant or lactating
- •Completed allergen specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years
- •SCIT or SLIT during the study period
- •Regular use of oral corticosteroids for exacerbations of asthma
- •Daily use of oral corticosteroids
- •Daily use of cyclosporine or other immunosuppressant drugs
- •Regular use of antibiotics
- •History of anaphylactic reaction to an allergen
- •Severe general diseases (especially cardiopulmonary disease with reduced lung capacity)
结局指标
主要结局
Change in house dust mite allergen concentration
时间窗: every two weeks, starting after randomisation untill completion of the study (5 months after randomisation)
Concentration of house dust mite allergen in dust collected from the mattress and pillow covers will be measured by using ELISA During the study, the patients will collect dust every 2 weeks (for each cover their will be 5 time points with an interval of 2 weeks on which dust will be collected)
次要结局
- change in discomfort during sleep(every week during the course of the study (from baseline till month 5))
- change in control of allergic rhinitis symptoms(every week during the course of the study (from baseline till month 5))
- Change in quality of life(every week during the course of the study (from baseline untill 5 months after))
- change in quality of sleep(every week during the course of the study (from start till 5 months))
- change in global discomfort(every week during the course of the study (from baseline till month 5))
- change in use of rescue medication(every week during the course of the study (from baseline till month 5))
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
The Effectiveness of Antibacterial Therapeutic Clothing Based on Silver or Chitosan as Compared With Non-antibacterial Therapeutic Clothing in Patients With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT04297215Erasmus Medical Center165
已完成
不适用
The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study)Foot Ulcer, DiabeticNCT02334241INRESA Pharma200
已完成
不适用
A Project to Study Probiotic Beauty Products on Skin ImprovementSkin DiseasesNCT05276661Chia Nan University of Pharmacy ＆ Science20
已完成
4 期
A Longitudinal Prospective Outcomes Study of Laparoscopic Abdominal Wall Hernia Repair Using Symbotex™ Composite MeshGrade I Ventral HerniaGrade II Ventral HerniaNCT02341430Anne Arundel Health System Research Institute50
招募中
不适用
Melodi Matrix™ in Breast ReconstructionBreast ReconstructionNCT06027996Melodi Health, Inc.702