Condition category
Respiratory
Date applied
28/09/2005
Date assigned
21/11/2005
Last edited
13/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Timothy Harrison

ORCID ID

Contact details

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

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 measures

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

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19590019

Publication citations

  1. 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.

Additional files

Editorial Notes