Condition category
Respiratory
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof C.P. Schayck, van

ORCID ID

Contact details

University Maastricht
Care and Public Health Research Institute - CAPHRI
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882446
onno.vanschayck@hag.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR370

Study information

Scientific title

Acronym

TICARA

Study hypothesis

Allergen avoidance allows tapering off inhaled corticosteroids (ICS) in house dust mite allergic asthma patients

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/1999

Overall trial end date

01/12/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

01/01/1999

Recruitment end date

01/12/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Maastricht
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

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

Sponsor details

P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882446
e.habets@caphri.unimaas.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Netherlands Asthma Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Boehringer Ingelheim BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AstraZeneca BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16701770

Publication citations

  1. Results

    de Vries MP, van den Bemt L, Thoonen BP, Muris JW, van Schayck CP, Relationship between house dust mite (HDM) allergen exposure level and inhaled corticosteroid dosage in HDM-sensitive asthma patients on a self management program., Prim Care Respir J, 2006, 15, 2, 110-115, doi: 10.1016/j.pcrj.2006.01.001.

Additional files

Editorial Notes