Tapering off Inhaled Corticosteroids in Asthma patients after Reduction of Allergens

ISRCTN	ISRCTN32862552
DOI	https://doi.org/10.1186/ISRCTN32862552
Secondary identifying numbers	NTR370

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof C.P. Schayck, van
Scientific

University Maastricht
Care and Public Health Research Institute - CAPHRI
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 3882446
Email	onno.vanschayck@hag.unimaas.nl

Study design	Multicentre randomised double blind placebo controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Scientific title
Study acronym	TICARA
Study objectives	Allergen avoidance allows tapering off inhaled corticosteroids (ICS) in house dust mite allergic asthma patients
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Asthma, Allergy
Intervention	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 mite impermeable covers for mattress, pillow and bedding. The control group received placebo, house dust mite permeable, covers.
Intervention type	Other
Primary outcome measure	Use of inhaled corticosteroids
Secondary outcome measures	1. Asthma control 2. Symptoms (dyspnoea, wheezing, coughing) 3. Peak flow parameters (morning peak flow, peak flow variability)
Overall study start date	01/01/1999
Completion date	01/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	150
Key inclusion criteria	1. Age 16-60 years 2. Treatment for asthma by the GP 3. Use of inhaled corticosteroids 4. Allergy for house dust mite allergens
Key exclusion criteria	1. Serious diseases other than asthma with a low survival rate 2. Other diseases, which influence bronchial symptoms and/or lung function 3. Exacerbation within one month before the start of the study 4. The use of oral steroids or inhaled cromoglycates 5. Use of house dust mite impermeable mattress/bedding covers 6. Allergy to cats or dogs while keeping these pets
Date of first enrolment	01/01/1999
Date of final enrolment	01/12/2004

University Maastricht

Maastricht
6200 MD
Netherlands

Care and Public Health Research Institute (CAPHRI), University Maastricht (Netherlands)
Research organisation

P.O. Box 616
Maastricht
6200 MD
Netherlands

Research organisation

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

Netherlands Asthma Foundation (Netherlands)

No information available

Boehringer Ingelheim BV (Netherlands)

No information available

AstraZeneca BV (Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2006		Yes	No