Allergic RhinitisPurotex coversNCT01997606
House Dust Mite Allergen Reduction in Bedding: Purotex Impregnated Covers of Bekaert Textiles
A study testing use of Purotex treated bedding covers in people with Allergic Rhinitis, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- use of Purotex treated bedding covers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Conditions
- Allergic Rhinitis
- Being tested
- use of Purotex treated bedding covers, placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of Purotex treated bedding coversOther
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).
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Purotex | Experimental | use of Purotex treated bedding covers Receives: Other: use of Purotex treated bedding covers |
| Placebo | Placebo comparator | no use of Purotex treated bedding covers Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: every two weeks, starting after randomisation untill completion of the study (5 months after randomisation)
Secondary outcomes (6)
Change in quality of life
questionnaires: RQLQ, NRQLQ
Measured: every week during the course of the study (from baseline untill 5 months after)
change in quality of sleep
Measured: every week during the course of the study (from start till 5 months)
change in control of allergic rhinitis symptoms
questionnaire
Measured: 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
Measured: 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)
Measured: every week during the course of the study (from baseline till month 5)
change in discomfort during sleep
Measured: every week during the course of the study (from baseline till month 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Bekaert textiles NV Waregem
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997606
- Sponsor's protocol ID
- 2012/398
- Acronym
- Purotex covers
- Status last verified
- Sep 2016
- First submitted
- 22 Nov 2013
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01997606
- Acronym / sponsor ID
- Purotex covers / 2012/398
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Bekaert textiles NV Waregem
- Study start
- Nov 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purotex | Experimental | Other: use of Purotex treated bedding coversuse of Purotex treated bedding covers |
| Placebo | Placebo comparator | Other: placebono use of Purotex treated bedding covers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of Purotex treated bedding coversPurotex 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). | Other | Purotex |
| placebo | Other | Placebo |
Primary outcome
Change in house dust mite allergen concentration
Time frame: 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)
6 secondary outcomes
Change in quality of life
Time frame: every week during the course of the study (from baseline untill 5 months after)
change in quality of sleep
Time frame: every week during the course of the study (from start till 5 months)
change in control of allergic rhinitis symptoms
Time frame: every week during the course of the study (from baseline till month 5)
change in global discomfort
Time frame: every week during the course of the study (from baseline till month 5)
change in use of rescue medication
Time frame: every week during the course of the study (from baseline till month 5)
change in discomfort during sleep
Time frame: every week during the course of the study (from baseline till month 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of Purotex treated bedding covers in people with Allergic Rhinitis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in house dust mite allergen concentration (time frame: every two weeks, starting after randomisation untill completion of the study (5 months after randomisation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.