Beta Agonist Lung injury Trial - Prevention Study - BALTI Prevention

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004096-19-GB

Enrollment

360

Registered

2008-02-21

Start date

2007-10-31

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Salmeterol Product Name: Salmeterol Pharmaceutical Form: Inhalation vapour, powder INN or Proposed INN: SALMETEROL CAS Numbe

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Acute respiratory distress syndrome (ARDS) is a serious condition affecting the lungs, making it difficult for the lungs to work effectiveley and get oxygen into the blood. ARDS also complicates approximately 25-30% of patients undergoing oesophagectomy (procedure to remove a portion of the lower gullet). This study aims to evaluate whether prophylactic (preventive) treatment with inhaled salmeterol will reduce the incidence of ARDS in patients undergoing elective oesophagectomy. ; Secondary Objective: -To evaluate the effects of Salmeterol on: -global severity of illness(APACHE II, SAPS II, SOFA); and respiratory severity of illness (oxygenation [PaO2:FiO2 ratio,lung injury score, lung water, [day 0 - extubation]) -lung and systemic inflammation. -To evaluate the ALI/ARDS within 28 days of surgery; 60 day and 1 year mortality. -To evaluate the effects of salmeterol on the number of days a patient is not on a ventilator. ;Primary end point(s): The primary outcome will be the development of clinically significant acute lung injury within 72 hours of oesophagectomy.	—

Measure

Time frame

Main Objective: Acute respiratory distress syndrome (ARDS) is a serious condition affecting the lungs, making it difficult for the lungs to work effectiveley and get oxygen into the blood. ARDS also complicates approximately 25-30% of patients undergoing oesophagectomy (procedure to remove a portion of the lower gullet). This study aims to evaluate whether prophylactic (preventive) treatment with inhaled salmeterol will reduce the incidence of ARDS in patients undergoing elective oesophagectomy. ; Secondary Objective: -To evaluate the effects of Salmeterol on: -global severity of illness(APACHE II, SAPS II, SOFA); and respiratory severity of illness (oxygenation [PaO2:FiO2 ratio,lung injury score, lung water, [day 0 - extubation]) -lung and systemic inflammation. -To evaluate the ALI/ARDS within 28 days of surgery; 60 day and 1 year mortality. -To evaluate the effects of salmeterol on the number of days a patient is not on a ventilator. ;Primary end point(s): The primary outcome will be the development of clinically significant acute lung injury within 72 hours of oesophagectomy.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 8, 2026