Contact information
Type
Scientific
Primary contact
Dr Gavin Perkins
ORCID ID
Contact details
Associate Clinical Professor
Department of Critical Care
2nd Floor
Lincoln House
Birmingham Heartlands Hospital
Birmingham
B9 5SS
United Kingdom
G.D.Perkins@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Beta Agonist Lung Injury TrIal (BALTI) Prevention Study: a multicentre, double-blind, randomised, placebo-controlled trial
Acronym
BALTI Prevention Study
Study hypothesis
Those recruited will be suffering from oesophageal cancer. They will be undergoing oesophagectomy and the surgical procedure will involve collapsing one lung. There is a high post-operative risk of acute lung injury.
Hypothesis:
Inhaled salmeterol prior to elective oesophagectomy will reduce the incidence of early acute lung injury.
Ethics approval
South Birmingham Ethics Committee approved on the 15th November 2007 (ref: 07/H1207/233)
Study design
Multicentre double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Oesophageal cancer
Intervention
Inhaled salmeterol (100 µg) via spacer immediately prior to surgery, and then afterwards twice daily for 72 hours, versus placebo inhaler. If the patient is ventilated the drug will be given through the inspiratory limb of the ventilator.
Intervention type
Drug
Phase
Not Applicable
Drug names
Salmeterol
Primary outcome measures
The development of clinically significant acute lung injury within 72 hours of oesophagectomy.
Secondary outcome measures
1. Global severity of illness at admission to Intensive Therapy Unit (ITU): Acute Physiology And Chronic Health Evaluation (APACHE II)
2. Severity of respiratory illness (partial pressure of oxygen in arterial blood [PaO2]:Fraction of inspired Oxygen [FiO2] ratio) daily for duration of intensive care unit (ITU)/high dependency unit (HDU) stay
3. Development of acute lung injury/acute respiratory distress syndrome (ARDS) at day 0 - 28
4. Ventilator free days
5. Organ failure free days
6. 28 and 90 day survival
7. Health related quality of life (EQ-5D) at baseline and at 28 and 90 days
Overall trial start date
01/03/2008
Overall trial end date
01/03/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Planned elective transthoracic oesophagectomy patients
2. Aged greater than 18 years
3. Male and female
4. Able to provide informed consent
5. Able to use a spacer device to deliver the drug
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
216 (increased to 360 as of 18/06/2009)
Participant exclusion criteria
1. Pregnancy
2. Current treatment with long acting beta agonist
3. Allergy to excipients in salmeterol
4. Current treatment with non-cardioselective beta-blockers
5. Treatment with investigational medicinal product (IMP) in the last 30 days
Recruitment start date
01/03/2008
Recruitment end date
01/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Associate Clinical Professor
Birmingham
B9 5SS
United Kingdom
Sponsor information
Organisation
Birmingham Heartlands Hospital (UK)
Sponsor details
c/o Dr Liz Adey
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Liz.Adey@heartofengland.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Department of Health (UK) - the Research Capacity Development (RCD) Programme (ref: PAS/02/06/RDA/010)
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
1. 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21406094
2. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24392848
Publication citations
-
Protocol
Perkins GD, Park D, Alderson D, Cooke MW, Gao F, Gates S, Lamb SE, Mistry D, Thickett DR, The Beta Agonist Lung Injury TrIal (BALTI)--prevention trial protocol., Trials, 2011, 12, 79, doi: 10.1186/1745-6215-12-79.
-
Results
Perkins GD, Gates S, Park D, Gao F, Knox C, Holloway B, McAuley DF, Ryan J, Marzouk J, Cooke MW, Lamb SE, Thickett DR, , The beta agonist lung injury trial prevention. A randomized controlled trial., Am. J. Respir. Crit. Care Med., 2014, 189, 6, 674-683, doi: 10.1164/rccm.201308-1549OC.