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
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study objectivesThat 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) studiedAsthma
InterventionComparison of the effect of increasing regular inhaled corticosteroid four-fold to continuing on same dose in the event of increasing asthma symptoms.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Corticosteroids
Primary outcome measureThe primary outcome will be the number of exacerbations requiring oral steroids in the active group compared with the placebo group.
Secondary outcome measuresThe 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 date01/04/2004
Completion date30/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants500
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2004
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department Respiratory Medicine
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Nottingham City Hospital NHS Trust (UK)
Hospital/treatment centre

Hucknall Road
Nottingham
NG5 1PB
England
United Kingdom

Phone +44 (0)115 9691169
Email gdochert@ncht.trent.nhs.uk
ROR logo "ROR" https://ror.org/05y3qh794

Funders

Funder type

Charity

Asthma UK (UK), ID 03/082

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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