Study in Intensive Care Patients Regarding the Effect of Inhaled AP-301 After Primary Graft Dysfunction After Lung Transplantation

PGD Primary Graft Dysfunction Clinical Trial

Official title:

Pilot Study to Investigate the Clinical Effect of Orally Inhaled AP301 on Treatment of Primary Graft Dysfunction (PGD) in Mechanically Ventilated Patients After Primary Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095626
• Other study ID #: AP-301-III-001
• Secondary ID: 2013-000716-21
• Status: Completed
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: March 2015

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 investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being a male or female recipient on the AKH`s waiting list for primary single or double LuTX

• PGD score = 1 within 72 hours after LuTX

• Informed consent is available

Exclusion Criteria:

• History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product

• Postoperative ECMO support

• Paediatric /adolescent recipients (< 18 years)

• Lobar transplantation

• Retransplantation

• Combined solid organ transplants

• Participation in other drug trials

Related Conditions & MeSH terms

• PGD Primary Graft Dysfunction
• Primary Graft Dysfunction

Intervention

Drug:
• AP-301
orally delivered doses of 87.6 mg AP301 (dose per subject, 5 ml nebulizer filling dose) are inhaled every 12 hours for a total of 7 days
• saline solution
placebo solution (0.9 % physiologic NaCl, 5 ml nebulizer filling dose) is inhaled every 12 hours for a total of 7 days

Locations

Country	Name	City	State
Austria	Division of Thoracic Surgery MedUni 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	P/F ratio	The changes of the P/F ratio from T0 (time of PGD diagnosis) to day 7 of the treatment or to extubation of the patient	7 days
Secondary	EVLW	Measurement of extravascular lung water	7 days or until extubation