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

NCT ID: NCT01627613

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-08-31

Brief 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.

Conditions

Acute Lung Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AP301

Treatment group

Group Type: EXPERIMENTAL

AP301

Intervention Type: DRUG

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 group

Group Type: PLACEBO_COMPARATOR

Saline solution

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Saline solution

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apeptico Forschung und Entwicklung GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman Ullrich, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Department of Anesthesia, General Intensive Care and Pain Control,Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

Krenn K, Lucas R, Croize A, Boehme S, Klein KU, Hermann R, Markstaller K, Ullrich R. Inhaled AP301 for treatment of pulmonary edema in mechanically ventilated patients with acute respiratory distress syndrome: a phase IIa randomized placebo-controlled trial. Crit Care. 2017 Jul 27;21(1):194. doi: 10.1186/s13054-017-1795-x.

Reference Type: DERIVED

PMID: 28750677 (View on PubMed)

Other Identifiers

2012-001863-64

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AP301-II-001

Identifier Type: -

Identifier Source: org_study_id