The value of measuring airway inflammation in the management of asthma
| ISRCTN | ISRCTN80754328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80754328 |
| Protocol serial number | RBF 00XX2 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Trent (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 18/05/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
LE3 9QP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
