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
This study is not yet open for participant recruitment.
Verified June 2012 by Apeptico Forschung und Entwicklung GmbH
Sponsor:
Apeptico Forschung und Entwicklung GmbH
Information provided by (Responsible Party):
Apeptico Forschung und Entwicklung GmbH
ClinicalTrials.gov Identifier:
NCT01627613
First received: June 20, 2012
Last updated: June 26, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lung Injury |
Drug: AP301 Drug: Saline solution |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Apeptico Forschung und Entwicklung GmbH:
Primary Outcome Measures:
- change in extravascular lung water within 7 days of treatment [ Time Frame: change from baseline - day 7 ] [ Designated as safety issue: No ]EVWL (measured with PiCCO® technique) until day 7 of treatment (AUC)
Secondary Outcome Measures:
- Oxygenation index [ Time Frame: baseline - day 7 ] [ Designated as safety issue: No ]Oxygenation index (PaO2 / FiO2 ratio) until day 7 of treatment
- ventilator plateau pressure [ Time Frame: baseline - day 7 ] [ Designated as safety issue: No ]Ventilator plateau pressure until day 7 of treatment
- Murray Lung Injury Score [ Time Frame: baseline - day 7 ] [ Designated as safety issue: No ]
- Ventilation parameters / lung function [ Time Frame: baseline - day 7 ] [ Designated as safety issue: No ]
- 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)) [ Time Frame: baseline - day 7 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AP301
Treatment group
|
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. |
|
Placebo Comparator: saline solution
Placebo group
|
Drug: Saline solution
Placebo solution (0.9% physiologic NaCl) is inhaled every 12 hours (± 30 min), for a total of 7 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627613
Contacts
| Contact: Bernhard Fischer, Doz. | 0043-664143 ext 2919 | b.fischer@apeptico.com |
Locations
| Austria | |
| Department of Anesthesia, General Intensive Care and Pain Control,Medical University of Vienna | Not yet recruiting |
| Vienna, Austria, 1090 | |
| Contact: Bernhard Fischer, Doz. 0043-664143 ext 2919 b.fischer@apeptico.com | |
| Principal Investigator: Roman Ullrich, Prof. | |
Sponsors and Collaborators
Apeptico Forschung und Entwicklung GmbH
Investigators
| Principal Investigator: | Roman Ullrich, Prof. | Medical University of Vienna |
More Information
No publications provided
| Responsible Party: | Apeptico Forschung und Entwicklung GmbH |
| ClinicalTrials.gov Identifier: | NCT01627613 History of Changes |
| Other Study ID Numbers: | AP301-II-001, 2012-001863-64 |
| Study First Received: | June 20, 2012 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Austria: Ethikkommission Austria: Agency for Health and Food Safety |
Additional relevant MeSH terms:
|
Acute Lung Injury Respiratory Distress Syndrome, Adult Lung Injury Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013