Can acute exacerbations of asthma be prevented with a four-fold increase in inhaled corticosteroid dose?
ISRCTN | ISRCTN46018181 |
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DOI | https://doi.org/10.1186/ISRCTN46018181 |
Secondary identifying numbers | 03/082 |
- Submission date
- 28/09/2005
- Registration date
- 21/11/2005
- Last edited
- 13/07/2009
- 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
Dr Timothy Harrison
Scientific
Scientific
Department Respiratory Medicine
Nottingham City Hospital NHS Trust
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Prevention |
Scientific title | |
Study objectives | That acute exacerbations of asthma requiring oral corticosteroids can be prevented with pre-emptive treatment with a four-fold increase in the dose of inhaled corticosteroid. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Asthma |
Intervention | Comparison of the effect of increasing regular inhaled corticosteroid four-fold to continuing on same dose in the event of increasing asthma symptoms. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Corticosteroids |
Primary outcome measure | The primary outcome will be the number of exacerbations requiring oral steroids in the active group compared with the placebo group. |
Secondary outcome measures | The total number of exacerbations and days with peak flow less than 15% baseline will also be compared. The sensitivity and specificity of our criteria to detect an exacerbation requiring prednisolone will be determined. The total dose of inhaled and oral corticosteroids used by both groups will be calculated. |
Overall study start date | 01/04/2004 |
Completion date | 30/09/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 500 |
Key inclusion criteria | 1. Written Informed consent prior to participation in the trial 2. Male or female patients 16 years of age or older 3. Documented diagnosis of asthma 4. Treatment with 200 to 1000 mcg inhaled beclomethasone dipropionate or equivalent 5. At least one exacerbation requiring a temporary increase in inhaled corticosteroid or oral corticosteroids in the preceding 12 months 6. No oral corticosteroids for 4 weeks prior to or during the run-in period |
Key exclusion criteria | 1. Other respiratory diagnosis or relevant medical condition 2. Smoking history of greater than 20 pack years 3. Subjects already using a management plan to deal with exacerbations and who would not wish to be randomised to placebo 4. Pregnant or nursing women |
Date of first enrolment | 01/04/2004 |
Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department Respiratory Medicine
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
Nottingham City Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Hucknall Road
Nottingham
NG5 1PB
England
United Kingdom
Phone | +44 (0)115 9691169 |
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gdochert@ncht.trent.nhs.uk | |
https://ror.org/05y3qh794 |
Funders
Funder type
Charity
Asthma UK (UK), ID 03/082
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/10/2009 | Yes | No |