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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR370 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Tapering off Inhaled Corticosteroids in Asthma patients after Reducation of Allergens.
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Scientific title:
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Does allergen avoidance allow tapering off inhaled coricosteroids in allergic asthmatic patients? - TICARA |
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Date of first enrolment:
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1/1/1999 |
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Target sample size:
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150 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=370 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Marjolein
Vries, de |
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Address:
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University Maastricht (UM), CAPHRI Research Institute, Department of General Practice,
P.O. Box 616
6200 MD
Maastricht
The Netherlands |
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Telephone:
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Email:
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marjolein.devries@hag.unimaas.nl |
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Affiliation:
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Name:
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C.P.
Schayck, van |
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Address:
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University Maastricht (UM), CAPHRI Research Institute, Department of General Practice,
P.O. Box 616
6200 MD
Maastricht
The Netherlands |
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Telephone:
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+31 (0)43 3882446 |
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Email:
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onno.vanschayck@hag.unimaas.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age of 16-60 year;
2. Treatment for asthma by the GP;
3. Use of inhaled corticosteroids;
4. Allergy for house dust mite allergens.
Exclusion criteria: 1. Serious diseases other than asthma with;
2. A low survival rate;
3. Other diseases, which influence bronchial symptoms and/ or lung function;
4. Exacerbation within one month before the start of the study;
5. The use of oral steroids or inhaled cromoglycates;
6. Use of house dust mite impermeable mattress/bedding covers;
7. Allergy to cats or dogs while keeping these pets.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Allergy, Asthma
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Intervention(s)
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All patients have been trained to use a self-management plan to adjust the dose of inhaled corticosteroids to symptoms and peak expiratory flow value.
After a run-in period of 3 months the intervention period with placebo controlled allergen avoidance started.
The participants in the intervention group received house dust miet impermeable covers for mattress, pillow and bedding.
The control group received placebo, house dust mite permeable, covers.
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Primary Outcome(s)
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Use of inhaled corticosteroids.
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Secondary Outcome(s)
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1. Asthma control;
2. Symptoms (dyspnoea, wheezing, coughing);
3. Peak flow parameters (morning peak flow, peak flow variability).
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Secondary ID(s)
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ISRCTN32862552
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N/A
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development, Boehringer Ingelheim, Netherlands Asthma Foundation, AstraZeneca
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