House Dust Mite Allergen Reduction in Bedding: Purotex Impregnated Covers of Bekaert Textiles

Not Applicable

Completed

• Conditions: Allergic Rhinitis
• Interventions: Other: use of Purotex treated bedding covers; Other: placebo

• Registration Number: NCT01997606
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-28
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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 ≥ 5.
• 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).

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Purotex	use of Purotex treated bedding covers	use of Purotex treated bedding covers
Placebo	placebo	no use of Purotex treated bedding covers

Primary Outcome Measures

Name	Time	Method
Change in house dust mite allergen concentration	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)

Secondary Outcome Measures

Name	Time	Method
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)	questionnaire
Change in quality of life	every week during the course of the study (from baseline untill 5 months after)	questionnaires: RQLQ, NRQLQ
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)	global discomfort due to allergic symptoms and discomfort from specific symptoms questionnaire VAS
change in use of rescue medication	every week during the course of the study (from baseline till month 5)	patients will fill out every week a questionnaire about the use of medication for their allergic rhinitis (and asthma)

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium