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

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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Other: placebo; Other: use of Purotex treated bedding covers

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Purotex; use of Purotex treated bedding covers	Other: use of Purotex treated bedding covers; 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. The active probiotics are placed inside of millions of capsules and are introduced during the textile production. These human friendly bacteria remain non-active until friction force is created between the mattress/pillow and the sleeper's body. Under the friction force a small part of the capsules is opened and probiotics become active. They saturate the bacterial capacity of the textile and by doing so, reduce the risk of dust mite allergen development and growth of molds and harmful bacteria. The patients will apply the covers around their mattress and around their pillow. On top of these covers the patients will apply their own fitted sheet and pillowcase (which they will change every 4 weeks).
Placebo Comparator: Placebo; no use of Purotex treated bedding covers	Other: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in house dust mite allergen concentration	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)	every two weeks, starting after randomisation untill completion of the study (5 months after randomisation)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Bekaert textiles NV Waregem

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): September 26, 2016
• Last Update Submitted That Met QC Criteria: September 23, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 2012/398