Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/01/2010
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 Christopher Brightling

ORCID ID

Contact details

Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RBF 00XX2

Study information

Scientific title

Acronym

Study hypothesis

Test the hypothesis that managing patients with asthma by effectively suppressing airway inflammation, using a standardised protocol, will improve the control of mild exacerbations, airway responsiveness and symptoms compared with standard clinical approach.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Asthma

Intervention

1. Treatment of airways inflammation
2. Standard care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Improved asthma control; control of airway inflammation; change in spirometry over one-year, severe exacerbations; total use of inhaled corticosteroids in each group; proportion of patients screened with a diagnosis of asthma without objective evidence.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/06/2000

Overall trial end date

18/05/2002

Reason abandoned

Eligibility

Participant inclusion criteria

80 patients with asthma

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

19/06/2000

Recruitment end date

18/05/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Trent (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

2002 resulrs in http://www.ncbi.nlm.nih.gov/pubmed/12480423

Publication citations

  1. Resulrs

    Green RH, Brightling CE, McKenna S, Hargadon B, Parker D, Bradding P, Wardlaw AJ, Pavord ID, Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial., Lancet, 2002, 360, 9347, 1715-1721, doi: 10.1016/S0140-6736(02)11679-5.

Additional files

Editorial Notes