Trial | NCT01627613  Report issue

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
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
Study Started
Jul 31
2012
Primary Completion
May 31
2014
Study Completion
Aug 31
2014
Last Update
Nov 18
2019

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.

AP301 Experimental

Treatment group

saline solution Placebo Comparator

Placebo group

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
No Results Posted