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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

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

June 20, 2012
August 28, 2014
July 2012
May 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01627613 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Lung Injury
  • 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.

  • Drug: Saline solution
    Placebo solution (0.9% physiologic NaCl) is inhaled every 12 hours (± 30 min), for a total of 7 days.
  • Experimental: AP301
    Treatment group
    Intervention: Drug: AP301
  • Placebo Comparator: saline solution
    Placebo group
    Intervention: Drug: Saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01627613
AP301-II-001, 2012-001863-64
Yes
Apeptico Forschung und Entwicklung GmbH
Apeptico Forschung und Entwicklung GmbH
Not Provided
Principal Investigator: Roman Ullrich, Prof. Medical University of Vienna
Apeptico Forschung und Entwicklung GmbH
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP