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
Secondary identifying numbers	N0013133760

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

Acute Medicine
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
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
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	salbutamol
Primary outcome measure	Main outcome measure peak expiratory flow rate (PEFR) (baseline - 15 minutes post salbutamol) and (baseline - 15 minutes post second dose of salbutamol)
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/03/2003
Completion date	01/03/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Not provided at time of registration
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

England
United Kingdom

Study participating centre

Acute Medicine

London
SE1 7EH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Guy's and St Thomas' NHS Trust (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

Editorial Notes

18/10/2017: No publications found in PubMed, verifying study status with principal investigator.