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

NCT00742482 | Terminated Phase 3 DMC

• 1 other identifier: HL 0101 INT
• Study Type: interventional
• Target: 418
• Locations: 12 countries
• Sites: 13

Brief Summary

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

Conditions

Acute Lung Injury; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 28 days mortality

  28 days

Secondary Outcomes (7)

• Days alive and off ventilator

  Day 29

• Days on ventilation

  Day 1 to Day 29

• Days alive and out of ICU

  Day 29

• Changes in Pao2/FiO2 ratios and other relevant lung parameters, changes in SOFA score

  From Day 1 to Day 4, Day 1 to Day 8, Day 4 to Day 8

• Dead/alive at discharge of ICU

  Followed until Day 180

Interventions

HL 10 DRUG

Freeze dried HL 10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (13)

Allgemeines Krankenhaus, Klinik für Anästhesie un Allgemeine Intensivmedizin

Vienna, 1090, Austria

Location

Erasme University Hospital

Brussels, 1070, Belgium

Location

Mount Sinai Hospital, Critical Care Unit

Toronto, Ontario, M5G 1X5, Canada

Location

Odense University Hospital

Odense C, 5000, Denmark

Location

Kuopio University Hospital, Intensive Care Unit

Kuopio, 70211, Finland

Location

Hôpital Pitié Salpétrière, Département d'Anesthésie Réanimation

Paris, 75651, France

Location

Klinik für Anästhesiologie der RWTH Aachen

Aachen, 52074, Germany

Location

Academisch Medisch Centrum

Amsterdam, 1005, Netherlands

Location

Department of Intensive Care Medicine

Utrecht, 3584, Netherlands

Location

Ullevål University Hospital, INtensive Care Department

Oslo, 0407, Norway

Location

Consorci Hospitalari Parc Taulí

Sabadell (Barcelona), 08208, Spain

Location

University Hospital of Lund, Department of Intensive Care

Lund, 221 85, Sweden

Location

St Thomas Hospital, Adult Intensive Care

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

• Lu Q, Zhang M, Girardi C, Bouhemad B, Kesecioglu J, Rouby JJ. Computed tomography assessment of exogenous surfactant-induced lung reaeration in patients with acute lung injury. Crit Care. 2010;14(4):R135. doi: 10.1186/cc9186. Epub 2010 Jul 15.

  PMID: 20633284 DERIVED

• Kesecioglu J, Beale R, Stewart TE, Findlay GP, Rouby JJ, Holzapfel L, Bruins P, Steenken EJ, Jeppesen OK, Lachmann B. Exogenous natural surfactant for treatment of acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2009 Nov 15;180(10):989-94. doi: 10.1164/rccm.200812-1955OC. Epub 2009 Aug 27.

  PMID: 19713451 DERIVED

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jozef Kesecioglu, MD, PhD

  Anaesthesist-Intensivist, Department of Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: January 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: June 1, 2005
• Last Updated: February 24, 2025

Record last verified: 2009-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); CA (1); NO (1); DE (1); BE (1); NL (2); ES (1); SE (1); AU (1); FI (1); DK (1); FR (1)