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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000716-21 | EudraCT Number |
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The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AP301 | Experimental | Treatment group |
|
| Saline solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP-301 | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| EVLW | Measurement of extravascular lung water | 7 days or until extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Klepetko, Univ.Prof.Dr.med.univ. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Thoracic Surgery MedUni Vienna | Vienna | 1090 | Austria |
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| saline solution | Drug | placebo solution (0.9 % physiologic NaCl, 5 ml nebulizer filling dose) is inhaled every 12 hours for a total of 7 days |
|
| ID | Term |
|---|---|
| C583752 | AP301 peptide |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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