NCT01627613

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Apeptico Forschung und Entwicklung GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2012-06-26
• Last updated: 2019-11-18

Locations

1 site across 1 country: Austria