Clinical and economic implications of stepping down inhaled corticosteroids in patients with chronic stable asthma
| ISRCTN | ISRCTN12335748 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12335748 |
| Protocol serial number | N/A |
| Sponsor | Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK) |
| Funder | NHS Asthma National Research and Development Programme (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 19/03/2007
- 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 Neil Thomson
Scientific
Scientific
Department of Respiratory Medicine
West Glasgow Hospitals University NHS Trust
1053 Gt. Western Road
Glasgow
G12 0YN
United Kingdom
| Phone | +44 (0)141 211 3241 |
|---|---|
| n.c.thomson@clinmed.gla.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The UK national guidelines for asthma management recommend a slow stepwise reduction of treatment in patients with chronic asthma which has been stable for a three to six month period. Inhaled steroids are highly effective in treating asthma, although, a plateau in the therapeutic response may exist for many asthmatic patients at doses below 1000 mcg daily. Concerns have been raised that some patients may be receiving inappropriately high doses of inhaled steroids. The aims of this study are to assess the clinical and economic implications of stepping down inhaled steroid treatment over a one year period on patients with chronic stable asthma receiving more than 1000 mcg inhaled steroid daily. The primary objectives are: 1. To compare the number of exacerbations of asthma in the group in whom the dose of inhaled steroid is reduced by up to 50% with those in whom the dose is unaltered over a one year period; 2. To perform an economic evaluation of the two management plans. The benefit the proposed investigation may bring to the National Health Service (NHS) is the cost-effective use of inhaled steroid treatment in asthma. |
| Ethics approval(s) | Ethical approval obtained in 1998. |
| Health condition(s) or problem(s) studied | Respiratory tract diseases: Asthma |
| Intervention | Step down inhaled steroid over one year |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Inhaled steroid |
| Primary outcome measure(s) |
Exacerbation rate |
| Key secondary outcome measure(s) |
Inhaled steroid dose |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 250 |
| Key inclusion criteria | Adult asthmatic patients |
| Key exclusion criteria | 1. Chronic Obstructive Pulmonary Disease (COPD) 2. Low dose inhaled steroids |
| Date of first enrolment | 02/01/1999 |
| Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Department of Respiratory Medicine
Glasgow
G12 0YN
United Kingdom
G12 0YN
United Kingdom
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 | 24/05/2003 | Yes | No |
