Beta Agonist Lung injury Trial - Prevention Study - BALTI Preventio

Phase 1

• Conditions: This programme of research will examine the role of beta-2 agonist as specific pharmacotherapy to reduce the incidence of Acute Lung Injury (ALI) / Acute Respiratory Distress Syndrome (ARDS) in patients undergoing elective oesophagectomy.

• Registration Number: EUCTR2007-004096-19-GB
• Lead Sponsor: Birmingham Heartlands Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-21
• Study Completion: 2012-08-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

1. Provision of informed consent.
2. Age >18years.
3. Planned elective transthoracic oesophagectomy.
4. Ability to use inhaler with spacer device.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnancy.
2. Current treatment with long acting beta agonist (any formulation).
3. Allergy to excipients contained in the salmeterol inhaler.
4 Current treatment with non-cardioselective beta blockers (the cardioselective beta blockers atenolol, betazolol, bisoprolol and metoprolol are permitted).
5. Treatment with an investigational medicinal product in the last 30 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified