BALTI-2: Beta Agonists in Lung Injury Trial - BALTI-2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002647-86-GB

Enrollment

1334

Registered

2008-02-27

Start date

2006-09-25

Completion date

Unknown

Last updated

2019-12-16

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

Conditions

Acute respiratory distress syndrome (ARDS)

Interventions

Trade Name: Ventolin Solution for Intravenous Infusion Product Name: Ventolin Solution for Intravenous Infusion 5mg in 5ml (1mg/ml) Pharmaceutical Form: Solution for in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Intubated patients (16 years of age or older) requiring mechanical ventilation within 72 hours of the onset of acute respiratory distress syndrome defined according to the American European Consensus definition of: - acute onset - severe hypoxaemic respiratory failure (PaO2/FiO2 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnancy - current treatment with intravenous beta2-agonists - current treatment with beta-adrenergic antagonists - treatment withdrawal imminent - chronic liver disease (defined as Pugh's grading 3: coma, bilirubin >55 mmol/l, albumin 6 seconds compared with control) - enrolled in another clinical trial of an investigational medicinal product in the past 28 days

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To evaluate the effects of salbutamol on ventilator free days in patients with ARDS To evaluate the effects of salbutamol on disability and health realted quality of life of patients with ARDS 12 months after randomisation To evaluate the safety of intravenous salbutamol in patients with ARDS To evaluate the cost-effectiveness of salbutamol for patients with ARDS ; Primary end point(s): 1. Clinical outcome measures: - Mortality before (first) discharge from ICU - Mortality at discharge from hospital - Mortality at 12 months post randomisation - Number of ventilator free days - Lung function and disability at 12 months after randomisation - Health related quality of life at 12 months after randomisation - Safety - side effects of salbutamol 2. Resource use: - ICU length of stay - Hospital length of stay ;Main Objective: To evaluate whether intravenous infusion of salbutamol reduces 28 day all-cause mortality in patients with ARDS	—

Measure

Time frame

Secondary Objective: To evaluate the effects of salbutamol on ventilator free days in patients with ARDS To evaluate the effects of salbutamol on disability and health realted quality of life of patients with ARDS 12 months after randomisation To evaluate the safety of intravenous salbutamol in patients with ARDS To evaluate the cost-effectiveness of salbutamol for patients with ARDS ; Primary end point(s): 1. Clinical outcome measures: - Mortality before (first) discharge from ICU - Mortality at discharge from hospital - Mortality at 12 months post randomisation - Number of ventilator free days - Lung function and disability at 12 months after randomisation - Health related quality of life at 12 months after randomisation - Safety - side effects of salbutamol 2. Resource use: - ICU length of stay - Hospital length of stay ;Main Objective: To evaluate whether intravenous infusion of salbutamol reduces 28 day all-cause mortality in patients with ARDS

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026