Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/03/2007
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

Prof Neil Thomson

ORCID ID

Contact details

Department of Respiratory Medicine
West Glasgow Hospitals University NHS Trust
1053 Gt. Western Road
Glasgow
G12 0YN
United Kingdom
+44 (0)141 211 3241
n.c.thomson@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The UK national guidelines for asthma management recommend a slow stepwise reduction of treatment in patients with chronic asthma which has been stable for a three to six month period. Inhaled steroids are highly effective in treating asthma, although, a plateau in the therapeutic response may exist for many asthmatic patients at doses below 1000 mcg daily. Concerns have been raised that some patients may be receiving inappropriately high doses of inhaled steroids. The aims of this study are to assess the clinical and economic implications of stepping down inhaled steroid treatment over a one year period on patients with chronic stable asthma receiving more than 1000 mcg inhaled steroid daily.

The primary objectives are:
1. To compare the number of exacerbations of asthma in the group in whom the dose of inhaled steroid is reduced by up to 50% with those in whom the dose is unaltered over a one year period;
2. To perform an economic evaluation of the two management plans. The benefit the proposed investigation may bring to the National Health Service (NHS) is the cost-effective use of inhaled steroid treatment in asthma.

Ethics approval

Ethical approval obtained in 1998.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Respiratory tract diseases: Asthma

Intervention

Step down inhaled steroid over one year

Intervention type

Drug

Phase

Not Specified

Drug names

Inhaled steroid

Primary outcome measures

Exacerbation rate

Secondary outcome measures

Inhaled steroid dose

Overall trial start date

02/01/1999

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Adult asthmatic patients

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

250

Participant exclusion criteria

1. Chronic Obstructive Pulmonary Disease (COPD)
2. Low dose inhaled steroids

Recruitment start date

02/01/1999

Recruitment end date

31/12/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Respiratory Medicine
Glasgow
G12 0YN
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Asthma National Research and Development Programme (UK)

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

Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12763981

Publication citations

  1. Results

    Hawkins G, McMahon AD, Twaddle S, Wood SF, Ford I, Thomson NC, Stepping down inhaled corticosteroids in asthma: randomised controlled trial., BMJ, 2003, 326, 7399, 1115, doi: 10.1136/bmj.326.7399.1115.

Additional files

Editorial Notes