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

Conditions: Acute Pulmonary oedema
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2012-001863-64-AT

Lead Sponsor: Apeptico Forschung und Entwicklung GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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
-Informed consent:
-For patients that are temporarily unable to consent (e.g. comatose patients) a subsequent informed consent has to be provided.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Medical Issues
•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 10^9 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
•Pregnancy / lactation or intention to fall pregnant during the time course of the study
•Women of childbearing potential who are not using adequate contraception

General Issues
•Participation in other interventional drug trials