Efficacy and Safety of 3 Doses of HL10 Given at Fixed Time Intervals Compared to Standard Therapy

LEO Pharma

Status and phase

Terminated

Phase 3

Conditions

Acute Respiratory Distress Syndrome

Acute Lung Injury

Treatments

Drug: HL 10

Study type

Interventional

Funder types

Industry

Identifiers

NCT00742482

HL 0101 INT

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given at fixed time intervals compared to standard therapy

Enrollment

418 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients intubated and on mechanical ventilation
Patients with Acute Lung Injury defined as (a, b, c and d are all applicable): a: PaO2/FiO2 < or equal to 300 mmHg (40.0 kPa) (regardless of PEEP level), b: Acute onset, c: Pulmonary artery wedge pressure < or equal to 18 mmHg when measured or no clinical evidence of left atrial hypertension, d: Bilateral infiltrates seen on frontal chest radiograph
Less than 60 hours from onset of the present period of mechanical ventilation to 1st instillation
Expected to continue on mechanical ventilation for more than 24 hours
18 years of age or older
Following receipt of verbal and written information about the trial, the patient or legally acceptable representative must provide signed and dated informed consent before any trial related activity is carried out

Exclusion criteria

Current diagnosis of acute bronchial asthma attack
History of or clinical suspicion of lung fibrosis
Current diagnosis of suspected pulmonary thrombo-embolism
Patients on daily medication for chronic obstructive pulmonary disease at time of admission to ICU
Patients who have received mechanical ventilation for more than 48 hours continuously within 1 month prior to the present period of mechanical ventilation
Patients with pneumonectomy or lobectomy
Patients with untreated pneumothorax at time of instillation
Patients having tracheostomy at time of instillation
Patients who have had surgical procedures under general anaesthesia performed within 6 hours prior to inclusion blood gas sample
Patients having mean arterial blood pressure < 50 mmHg in spite of adequate fluid administration and/or vasoactive drugs at time of instillation
Patients having PaO2 < 75 mmHg with a FiO2 = 1.0 not responding to adjustment of PEEP at time of instillation
Glasgow Coma Score < or equal to 10 before sedation or major findings on CT/MR scan of the head such as: brain oedema, acute space occupying lesion, other acute lesions with bleeding or mass effect (patients with minor lesion which do not require further diagnostics or monitoring can be included)
Patients with life expectancy less than 3 months due to primary disease assessed by the attending physician (e.g., end-stage cancer, AIDS or generally poor health)
Known or suspected hypersensitivity to constituents(s) of the investigational product
Patients who have received treatment with any investigational drug within the previous 4 weeks
Current participation in any other interventional clinical trial until day 29 of the trial
Patients previously randomised in this trial
Patients known or suspected of not being able to comply with a study protocol (e.g., due to alcoholism, drug dependency or psychotic state)
Females of childbearing potential who have a positive pregnancy test or who are breast feeding
Patients suffering from highly infectious diseases where trial related procedures could pose a safety risk for the staff (e.g., SARS)