Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
04/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Leman

ORCID ID

Contact details

Acute Medicine
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013133760

Study information

Scientific title

Randomised controlled trial of nebulised and metered dose inhaler via spacer salbutamol in acute moderate to severe asthma

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

salbutamol

Primary outcome measures

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 trial start date

01/03/2003

Overall trial end date

01/03/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/2003

Recruitment end date

01/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Acute Medicine
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Guy's and St Thomas' NHS Trust (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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes