Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
RBF 00XX2
Study information
Scientific title
The value of measuring airway inflammation in the management of asthma
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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Asthma
Intervention
1. Treatment of airways inflammation
2. Standard care
Intervention type
Other
Primary outcome measure
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 study start date
19/06/2000
Overall study end date
18/05/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
80 patients with asthma
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
80
Total final enrolment
74
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
19/06/2000
Recruitment end date
18/05/2002
Locations
Countries of recruitment
England, United Kingdom
Study 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
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
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/11/2002 | Yes | No |