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

Acute Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627613
• Other study ID #: AP301-II-001
• Secondary ID: 2012-001863-64
• Status: Completed
• Phase: Phase 2
• Start date: July 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2019
• Source: Apeptico Forschung und Entwicklung GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Wounds and Injuries

Intervention

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.
• Saline solution
Placebo solution (0.9% physiologic NaCl) is inhaled every 12 hours (± 30 min), for a total of 7 days.

Locations

Country	Name	City	State
Austria	Department of Anesthesia, General Intensive Care and Pain Control,Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Apeptico Forschung und Entwicklung GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in extravascular lung water within 7 days of treatment	EVWL (measured with PiCCO® technique) until day 7 of treatment (AUC)	change from baseline - day 7
Secondary	Oxygenation index	Oxygenation index (PaO2 / FiO2 ratio) until day 7 of treatment	baseline - day 7
Secondary	ventilator plateau pressure	Ventilator plateau pressure until day 7 of treatment	baseline - day 7
Secondary	Murray Lung Injury Score		baseline - day 7
Secondary	Ventilation parameters / lung function		baseline - day 7
Secondary	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))		baseline - day 7