Status:
COMPLETED
Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II
Lead Sponsor:
Faron Pharmaceuticals Ltd
Conditions:
Acute Lung Injury
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome ...
Detailed Description
This was a phase I/II open-label study to assess the safety, tolerability and preliminary efficacy of FP-1201 (IFN β-1a) in the treatment of patients with ALI and ARDS. The primary objective in the s...
Eligibility Criteria
Inclusion
- Adult male or female patients with ALI/ARDS confirmed by the combination of the following diagnostic criteria:
- An initiating clinical condition (e.g. sepsis, pneumonia, aspiration pneumonia, pancreatitis etc.)
- Acute onset
- Bilateral infiltrates documented by chest radiograph at end-aspiratory position
- The absence of clinical evidence of left atrial hypertension
- ALI: partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) ratio ≤300 mmHg in a stable state after the patient has adapted to standardised ventilation. (Within the UK this equates to \<40kPa)
- ARDS: PaO2 /FiO2 ≤200 mmHg in a stable state after the patient has adapted to standardised ventilation. (Within the UK this equates to \<26.7kPa)
- Provision of signed written informed consent from the patient or patients legally authorized representative.
- Age greater than or equal to 18.
- Initiation of study drug within 48 hours of the diagnosis of ALI/ARDS.
- All patients at entry are required to be receiving mechanical ventilatory support.
- Only patients who are considered suitable for active life support should be enrolled in the study.
- No clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates; if measured the pulmonary arterial wedge pressure should be less than or equal to 18mmHg
Exclusion
- Patients with burns.
- Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
- Patients with significant Chronic Obstructive Pulmonary Disease requiring ongoing treatment e.g. chronic use of oxygen or ventilatory support at home prior to admission.
- Patients with primary lung cancer or the presence of secondary metastases in the lungs.
- Patients requiring treatment for congestive heart failure.
- Patients receiving renal dialysis therapy for chronic renal failure.
- Patients taking immunomodulatory therapy or oral steroids on admission.
- Prior use of interferon.
- Inability to maintain blood pressure to ensure adequate end organ perfusion. It should be noted that the use of plasma colloids or vasopressor agents is allowed to achieve the maintenance of blood pressure.
- Current participation in another experimental treatment protocol.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00789685
Start Date
February 1 2009
End Date
September 1 2011
Last Update
May 27 2015
Active Locations (8)
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1
University Hospital of Wales
Cardiff, United Kingdom, CG14 4XW
2
Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA
3
Western Infirmary
Glasgow, United Kingdom, G11 6NT
4
Victoria Infirmary
Glasgow, United Kingdom, G42 9TY