Condition category
Respiratory
Date applied
13/07/2006
Date assigned
17/08/2006
Last edited
10/03/2008
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 Dominick Shaw

ORCID ID

Contact details

17 Arleston Drive
Wollaton
Nottingham
NG8 2FR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03/050

Study information

Scientific title

Acronym

Study hypothesis

Use of exhaled nitric oxide will result in fewer asthma exacerbations.

Ethics approval

University Hospitals of Leicester (ref. no.: 9141) and the Leicester Primary Research Care Alliance (ref. no.: 0274).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Asthma

Intervention

Titrate steroid dose on basis of exhaled nitric oxide versus control group receiving treatment as per current BTS (British Thoracic Society) guidelines.

Intervention type

Drug

Phase

Not Specified

Drug names

Nitric oxide

Primary outcome measures

Asthma exacerbations.

Secondary outcome measures

Steroid dose (area under curve).

Overall trial start date

01/01/2004

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Asthma
2. On treatment, providing it is a repeat prescription i.e., the patient suffers from chronic asthma
3. Aged 18-85

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Recent exacerbation

Recruitment start date

01/01/2004

Recruitment end date

01/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

17 Arleston Drive
Nottingham
NG8 2FR
United Kingdom

Sponsor information

Organisation

Asthma UK (UK)

Sponsor details

Summit House
70 Wilson Street
London
EC2A 2DB
United Kingdom

Sponsor type

Charity

Website

http://www.asthma.org.uk/

Funders

Funder type

Charity

Funder name

Asthma UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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&list_uids=17496226

Publication citations

  1. Results

    Shaw DE, Berry MA, Thomas M, Green RH, Brightling CE, Wardlaw AJ, Pavord ID, The use of exhaled nitric oxide to guide asthma management: a randomized controlled trial., Am. J. Respir. Crit. Care Med., 2007, 176, 3, 231-237, doi: 10.1164/rccm.200610-1427OC.

Additional files

Editorial Notes