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

Apeptico

Status and phase

Completed

Phase 2

Conditions

Acute Lung Injury

Treatments

Drug: Saline solution

Drug: AP301

Study type

Interventional

Funder types

Industry

Identifiers

NCT01627613

2012-001863-64 (EudraCT Number)

AP301-II-001

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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