Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Apeptico Forschung und Entwicklung GmbH
ClinicalTrials.gov Identifier:
NCT01627613
First received: June 20, 2012
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Acute Lung Injury
Drug: AP301
Drug: Saline solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Apeptico Forschung und Entwicklung GmbH:

Primary Outcome Measures:
  • change in extravascular lung water within 7 days of treatment [ Time Frame: change from baseline - day 7 ] [ Designated as safety issue: No ]
    EVWL (measured with PiCCO® technique) until day 7 of treatment (AUC)


Secondary Outcome Measures:
  • Oxygenation index [ Time Frame: baseline - day 7 ] [ Designated as safety issue: No ]
    Oxygenation index (PaO2 / FiO2 ratio) until day 7 of treatment

  • ventilator plateau pressure [ Time Frame: baseline - day 7 ] [ Designated as safety issue: No ]
    Ventilator plateau pressure until day 7 of treatment

  • Murray Lung Injury Score [ Time Frame: baseline - day 7 ] [ Designated as safety issue: No ]
  • Ventilation parameters / lung function [ Time Frame: baseline - day 7 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 2012
Study Completion Date: August 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AP301
Treatment group
Drug: AP301

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.

Placebo Comparator: saline solution
Placebo group
Drug: Saline solution
Placebo solution (0.9% physiologic NaCl) is inhaled every 12 hours (± 30 min), for a total of 7 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627613

Locations
Austria
Department of Anesthesia, General Intensive Care and Pain Control,Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Apeptico Forschung und Entwicklung GmbH
Investigators
Principal Investigator: Roman Ullrich, Prof. Medical University of Vienna
  More Information

No publications provided

Responsible Party: Apeptico Forschung und Entwicklung GmbH
ClinicalTrials.gov Identifier: NCT01627613     History of Changes
Other Study ID Numbers: AP301-II-001, 2012-001863-64
Study First Received: June 20, 2012
Last Updated: August 28, 2014
Health Authority: Austria: Ethikkommission
Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Acute Lung Injury
Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014