Allergic Rhinitis Clinical Trial
Official title:
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.
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
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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