Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 A

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.

Detailed Summary:
Sponsor: Apeptico Forschung und Entwicklung GmbH

Current Primary Outcome: change in extravascular lung water within 7 days of treatment [ Time Frame: change from baseline - day 7 ]

EVWL (measured with PiCCO® technique) until day 7 of treatment (AUC)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Oxygenation index [ Time Frame: baseline - day 7 ]
    Oxygenation index (PaO2 / FiO2 ratio) until day 7 of treatment
  • ventilator plateau pressure [ Time Frame: baseline - day 7 ]
    Ventilator plateau pressure until day 7 of treatment
  • Murray Lung Injury Score [ Time Frame: baseline - day 7 ]
  • Ventilation parameters / lung function [ Time Frame: baseline - day 7 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Apeptico Forschung und Entwicklung GmbH

Dates:
Date Received: June 20, 2012
Date Started: July 2012
Date Completion:
Last Updated: August 28, 2014
Last Verified: August 2014