The value of measuring airway inflammation in the management of asthma
| ISRCTN | ISRCTN80754328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80754328 |
| Secondary identifying numbers | RBF 00XX2 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Christopher Brightling
Scientific
Scientific
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The value of measuring airway inflammation in the management of asthma |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 18/05/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 74 |
| Key inclusion criteria | 80 patients with asthma |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 19/06/2000 |
| Date of final enrolment | 18/05/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
LE3 9QP
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Trent (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | 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 |
Editorial Notes
08/11/2022: The following changes have been made:
1. Publication reference reclassified as results.
2. The final enrolment number has been added from the reference.
