|- candidate number||1580|
|- NTR Number||NTR370|
|- Date ISRCTN created||19-dec-2005|
|- date ISRCTN requested||28-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Tapering off Inhaled Corticosteroids in Asthma patients after Reducation of Allergens.|
|- Scientific Title||Does allergen avoidance allow tapering off inhaled coricosteroids in allergic asthmatic patients?|
|- hypothesis||Allergen avoidance allows tapering off inhaled corticosteroids (ICS) in house dust mite allergic asthma patients.|
|- Healt Condition(s) or Problem(s) studied||Allergy, Asthma|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-1999|
|- planned closingdate||1-dec-2004|
|- Target number of participants||150|
|- Interventions||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.
|- Primary outcome||Use of inhaled corticosteroids.|
|- Secondary outcome||1. Asthma control;|
2. Symptoms (dyspnoea, wheezing, coughing);
3. Peak flow parameters (morning peak flow, peak flow variability).
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. C.P. Schayck, van|
|- CONTACT for SCIENTIFIC QUERIES||GP. Marjolein Vries, de|
|- Sponsor/Initiator ||University Maastricht (UM), CAPHRI Research Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Boehringer Ingelheim, Netherlands Asthma Foundation, AstraZeneca|
|- Publications||1. de Vries MP, van Schayck CP Bestaat er een verband tussen het optreden van luchtweginfecties op jonge leeftijd en het ontstaan van atopie? Longartsenvademecum, nummer 2- februari 2000; |
2. van den Bemt L, van Knapen L, de Vries MP, Jansen M, Cloosterman S, van Schayck CP. Clinical effectiveness of a mite-allergen impermeable bed covering system in asthmatic mite-sensitive patients. J Allergy Clin Immun, 2004, 114 (4): 858-62;
3. de Vries MP, van den Bemt L, van der Mooren FM, Muris JWM, van Schayck CP. The prevalence of house dust mite allergy and the use of HDM impermeable covers in a primary care population of patients with persistent asthma in the Netherlands. Prim Care Respir J, 2005, 14 (4): 210-4;
4. de Vries MP, van den Bemt L, Lince S, Muris JWM, Thoonen BPA, van Schayck CP. Factors associated with asthma control. J Asthma, 2005, in press.
|- Brief summary||In this study the hypothesis was tested whether allergen avoidance allows tapering off inhaled corticosteroids (ICS) in house dust mite allergic asthma patients. |
Asthma patients between 16 and 60 years using ICS were selected from general practices and the general population. With a RAST allergy for house dust mite and other common allergens was determined.
Patients having an allergy to cats and dogs whilst these animals were present in the house were excluded. Patients were instructed by the GP or a nurse to use a self-management plan to adjust the dose of ICS.
After a baseline period of three months patients received house dust mite impermeable bed covers or placebo covers. Follow-up period was two years. Medication use, symptoms and peakflow were recorded in diaries. Exposure to house dust mite allergens was determined by means of dust samples taken from mattresses, by vacuum cleaning in a standardised way.
|- Main changes (audit trail)|
|- RECORD||12-sep-2005 - 16-jun-2008|