Condition category
Cancer
Date applied
02/01/2008
Date assigned
29/02/2008
Last edited
09/01/2014
Prospective/Retrospective
Prospectively 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 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

  1. 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.

  2. 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.

Additional files

Editorial Notes