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

A

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

AP301
Experimental group
Description:
Treatment group
Treatment:
Drug: AP301
saline solution
Placebo Comparator group
Description:
Placebo group
Treatment:
Drug: Saline solution

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems