Tapering off Inhaled Corticosteroids in Asthma patients after Reduction of Allergens
| ISRCTN | ISRCTN32862552 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32862552 |
| Protocol serial number | NTR370 |
| Sponsor | Care and Public Health Research Institute (CAPHRI), University Maastricht (Netherlands) |
| Funders | Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Netherlands Asthma Foundation (Netherlands), Boehringer Ingelheim BV (Netherlands), AstraZeneca BV (Netherlands) |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof C.P. Schayck, van
Scientific
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 |
|---|---|
| onno.vanschayck@hag.unimaas.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Use of inhaled corticosteroids |
| Key secondary outcome measure(s) |
1. Asthma control |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Maastricht
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2006 | Yes | No |
