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Study in Intensive Care Patients to Investigate the Clinical Effect of Repetitive Orally Inhaled Doses of AP301 on Alveolar Liquid Clearance in Acute Lung Injury

Primary Purpose

Acute Lung Injury

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
AP301
Saline solution
Sponsored by
Apeptico Forschung und Entwicklung GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring Peptide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥ 18
  • intubated and mechanically ventilated male and female patients of the Intensive Care Units of the Department of Anesthesia, General Intensive Care and Pain Control
  • meets the criteria of ALI (as defined by the American-European Consensus Conference on ALI/ ARDS):
  • Onset of ALI within 48 hours
  • Bilateral infiltrates seen on frontal chest radiograph
  • PCWP ≤ 18 mm Hg or no clinical evidence of left atrial hypertension
  • paO2/ FiO2 ratio ≤ 300 mm Hg
  • EVLW in PiCCO® at screening ≥ 8 ml/PBW
  • Meeting criteria for extensive hemodynamic monitoring according to investigators discretion
  • ICU Patients being mechanically ventilated and are stable in this condition for at least 8 hours
  • Negative pregnancy test and adequate contraception in female patients of childbearing potential
  • Informed consent:
  • For patients that are temporarily unable to consent (e.g. comatose patients) a subsequent informed consent has to be provided.

Exclusion Criteria:

  • History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product
  • Brainstem death at screening
  • Current evidence of septic shock as defined by the Surviving Sepsis Campaign (Presence of acute organ dysfunction secondary to infection plus hypotension with systolic blood pressure < 90 mm Hg or mean arterial pressure (MAP) < 70 mm Hg for not less than one hour which cannot be reversed with fluid resuscitation)
  • Neutrophil count <0.3 x 109 L
  • Patients under immunosuppression: high dose steroids (> 80 mg Prednisolone /d; > 300 mg hydrocortisone / d), cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks
  • BMI < 18.5 or > 35
  • Cardiogenic pulmonary edema diagnosed by echocardiography or pulmonary artery catheter
  • Pregnancy / lactation or intention to fall pregnant during the time course of the study
  • Women of childbearing potential as well as men of procreative capacity who are not using adequate contraception
  • Participation in other interventional drug trials

Sites / Locations

  • Department of Anesthesia, General Intensive Care and Pain Control,Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AP301

saline solution

Arm Description

Treatment group

Placebo group

Outcomes

Primary Outcome Measures

change in extravascular lung water within 7 days of treatment
EVWL (measured with PiCCO® technique) until day 7 of treatment (AUC)

Secondary Outcome Measures

Oxygenation index
Oxygenation index (PaO2 / FiO2 ratio) until day 7 of treatment
ventilator plateau pressure
Ventilator plateau pressure until day 7 of treatment
Murray Lung Injury Score
Ventilation parameters / lung function
Presence/absence/severity and duration of adverse effects - number and severity of adverse events (AEs), serious adverse events (SAEs) and suspected unexpected serious adverse events (SUSARs))

Full Information

First Posted
June 20, 2012
Last Updated
November 15, 2019
Sponsor
Apeptico Forschung und Entwicklung GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01627613
Brief Title
Study in Intensive Care Patients to Investigate the Clinical Effect of Repetitive Orally Inhaled Doses of AP301 on Alveolar Liquid Clearance in Acute Lung Injury
Official Title
Proof of Concept Study in Male and Female Intensive Care Patients to Investigate the Clinical Effect of Repetitive Orally Inhaled Doses of AP301 on Alveolar Liquid Clearance in Acute Lung Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apeptico Forschung und Entwicklung GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the effect of orally inhaled AP301 on alveolar liquid clearance in ALI (acute lung injury) patients with the purpose to assess the treatment associated changes of extravascular lung water (EVLW) within 7 days of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
Peptide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AP301
Arm Type
Experimental
Arm Description
Treatment group
Arm Title
saline solution
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Drug
Intervention Name(s)
AP301
Intervention Description
AP301 25 mg powder for reconstitution for solution for inhalation Orally delivered doses of 87.6 mg AP301 are inhaled every 12 hours (± 30 min), for a total of 7 days.
Intervention Type
Drug
Intervention Name(s)
Saline solution
Intervention Description
Placebo solution (0.9% physiologic NaCl) is inhaled every 12 hours (± 30 min), for a total of 7 days.
Primary Outcome Measure Information:
Title
change in extravascular lung water within 7 days of treatment
Description
EVWL (measured with PiCCO® technique) until day 7 of treatment (AUC)
Time Frame
change from baseline - day 7
Secondary Outcome Measure Information:
Title
Oxygenation index
Description
Oxygenation index (PaO2 / FiO2 ratio) until day 7 of treatment
Time Frame
baseline - day 7
Title
ventilator plateau pressure
Description
Ventilator plateau pressure until day 7 of treatment
Time Frame
baseline - day 7
Title
Murray Lung Injury Score
Time Frame
baseline - day 7
Title
Ventilation parameters / lung function
Time Frame
baseline - day 7
Title
Presence/absence/severity and duration of adverse effects - number and severity of adverse events (AEs), serious adverse events (SAEs) and suspected unexpected serious adverse events (SUSARs))
Time Frame
baseline - day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 18 intubated and mechanically ventilated male and female patients of the Intensive Care Units of the Department of Anesthesia, General Intensive Care and Pain Control meets the criteria of ALI (as defined by the American-European Consensus Conference on ALI/ ARDS): Onset of ALI within 48 hours Bilateral infiltrates seen on frontal chest radiograph PCWP ≤ 18 mm Hg or no clinical evidence of left atrial hypertension paO2/ FiO2 ratio ≤ 300 mm Hg EVLW in PiCCO® at screening ≥ 8 ml/PBW Meeting criteria for extensive hemodynamic monitoring according to investigators discretion ICU Patients being mechanically ventilated and are stable in this condition for at least 8 hours Negative pregnancy test and adequate contraception in female patients of childbearing potential Informed consent: For patients that are temporarily unable to consent (e.g. comatose patients) a subsequent informed consent has to be provided. Exclusion Criteria: History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product Brainstem death at screening Current evidence of septic shock as defined by the Surviving Sepsis Campaign (Presence of acute organ dysfunction secondary to infection plus hypotension with systolic blood pressure < 90 mm Hg or mean arterial pressure (MAP) < 70 mm Hg for not less than one hour which cannot be reversed with fluid resuscitation) Neutrophil count <0.3 x 109 L Patients under immunosuppression: high dose steroids (> 80 mg Prednisolone /d; > 300 mg hydrocortisone / d), cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks BMI < 18.5 or > 35 Cardiogenic pulmonary edema diagnosed by echocardiography or pulmonary artery catheter Pregnancy / lactation or intention to fall pregnant during the time course of the study Women of childbearing potential as well as men of procreative capacity who are not using adequate contraception Participation in other interventional drug trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Ullrich, Prof.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, General Intensive Care and Pain Control,Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
28750677
Citation
Krenn K, Lucas R, Croize A, Boehme S, Klein KU, Hermann R, Markstaller K, Ullrich R. Inhaled AP301 for treatment of pulmonary edema in mechanically ventilated patients with acute respiratory distress syndrome: a phase IIa randomized placebo-controlled trial. Crit Care. 2017 Jul 27;21(1):194. doi: 10.1186/s13054-017-1795-x.
Results Reference
derived

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Study in Intensive Care Patients to Investigate the Clinical Effect of Repetitive Orally Inhaled Doses of AP301 on Alveolar Liquid Clearance in Acute Lung Injury

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