Randomised controlled trial of nebulised and metered dose inhaler via spacer salbutamol in acute moderate to severe asthma
| ISRCTN | ISRCTN46758872 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46758872 |
| Protocol serial number | N0013133760 |
| Sponsor | Department of Health |
| Funder | Guy's and St Thomas' NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 18/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Leman
Scientific
Scientific
Acute Medicine
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Randomised controlled trial of nebulised and metered dose inhaler via spacer salbutamol in acute moderate to severe asthma |
| Study objectives | In acute moderate to severe asthma, is inhaled salbutamol delivery improved by using a metered dose inhaler and spacer device compared with a gas driven jet nebuliser? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Asthma |
| Intervention | Patients with acute moderate to severe asthma will be randomised to receive inhaled salbutamol either by gas driven nebuliser or by metered dose inhaler and spacer device. Patients will be given oxygen by nasal prongs and an assessment of their asthma severity made. Those with life threatening features will be enrolled. After randomisation they will receive 20 puffs (2 mg) of salbutamol via the spacer device (Volumatic) or 20 puffs of placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | salbutamol |
| Primary outcome measure(s) |
Main outcome measure peak expiratory flow rate (PEFR) (baseline - 15 minutes post salbutamol) and (baseline - 15 minutes post second dose of salbutamol) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Key inclusion criteria | Adult patients presenting to the emergency department with acute moderate to severe asthma. They will have auscultatory expiratory wheeze and dyspnoea. The severity of their asthma will be determined by reference to the British Thoracic Society (BTS) guidelines on the management of acute asthma. Patients will be excluded if they have any life threatening features as defined in the BTS guidelines. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 01/03/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Acute Medicine
London
SE1 7EH
United Kingdom
SE1 7EH
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/10/2017: No publications found in PubMed, verifying study status with principal investigator.
