Can acute exacerbations of asthma be prevented with a four-fold increase in inhaled corticosteroid dose?

ISRCTN	ISRCTN46018181
DOI	https://doi.org/10.1186/ISRCTN46018181
Protocol serial number	03/082
Sponsor	Nottingham City Hospital NHS Trust (UK)
Funder	Asthma UK (UK), ID 03/082

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Timothy Harrison
Scientific

Department Respiratory Medicine
Nottingham City Hospital NHS Trust
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Corticosteroids
Primary outcome measure(s)	The primary outcome will be the number of exacerbations requiring oral steroids in the active group compared with the placebo group.
Key secondary outcome measure(s)	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.
Completion date	30/09/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Department Respiratory Medicine

Nottingham
NG5 1PB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009		Yes	No