Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
03/082
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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 names
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 trial start date
01/04/2004
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant 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
Recruitment start date
01/04/2004
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department Respiratory Medicine
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
Nottingham City Hospital NHS Trust (UK)
Sponsor details
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 9691169
gdochert@ncht.trent.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Asthma UK (UK), ID 03/082
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19590019
Publication citations
-
Results
Oborne J, Mortimer K, Hubbard RB, Tattersfield AE, Harrison TW, Quadrupling the dose of inhaled corticosteroid to prevent asthma exacerbations: a randomized, double-blind, placebo-controlled, parallel-group clinical trial., Am. J. Respir. Crit. Care Med., 2009, 180, 7, 598-602, doi: 10.1164/rccm.200904-0616OC.