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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
use of Purotex treated bedding covers
placebo
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Purotex

Placebo

Arm Description

use of Purotex treated bedding covers

no use of Purotex treated bedding covers

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in quality of life
questionnaires: RQLQ, NRQLQ
change in quality of sleep
change in control of allergic rhinitis symptoms
questionnaire
change in global discomfort
global discomfort due to allergic symptoms and discomfort from specific symptoms questionnaire VAS
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)
change in discomfort during sleep

Full Information

First Posted
November 22, 2013
Last Updated
September 23, 2016
Sponsor
University Hospital, Ghent
Collaborators
Bekaert textiles NV Waregem
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1. Study Identification

Unique Protocol Identification Number
NCT01997606
Brief Title
House Dust Mite Allergen Reduction in Bedding: Purotex Impregnated Covers of Bekaert Textiles
Acronym
Purotex covers
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Bekaert textiles NV Waregem

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Purotex
Arm Type
Experimental
Arm Description
use of Purotex treated bedding covers
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
no use of Purotex treated bedding covers
Intervention Type
Other
Intervention Name(s)
use of Purotex treated bedding covers
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in house dust mite allergen concentration
Description
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)
Time Frame
every two weeks, starting after randomisation untill completion of the study (5 months after randomisation)
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
questionnaires: RQLQ, NRQLQ
Time Frame
every week during the course of the study (from baseline untill 5 months after)
Title
change in quality of sleep
Time Frame
every week during the course of the study (from start till 5 months)
Title
change in control of allergic rhinitis symptoms
Description
questionnaire
Time Frame
every week during the course of the study (from baseline till month 5)
Title
change in global discomfort
Description
global discomfort due to allergic symptoms and discomfort from specific symptoms questionnaire VAS
Time Frame
every week during the course of the study (from baseline till month 5)
Title
change in use of rescue medication
Description
patients will fill out every week a questionnaire about the use of medication for their allergic rhinitis (and asthma)
Time Frame
every week during the course of the study (from baseline till month 5)
Title
change in discomfort during sleep
Time Frame
every week during the course of the study (from baseline till month 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

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

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