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
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
-
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.