Acute Lung InjuryPhase 2NCT01627613
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
A Phase 2 study testing AP301 and Saline solution in people with Acute Lung Injury, run by Apeptico Forschung und Entwicklung GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- AP301 and Saline solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2012to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Anesthesia, General Intensive Care and Pain Control,Medical University of Vienna
Vienna, 1090
About this study
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
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
- Being tested
- AP301, Saline solution
- Keywords
- Peptide
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP301Drug
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 solutionDrug
Placebo solution (0.9% physiologic NaCl) is inhaled every 12 hours (± 30 min), for a total of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| AP301 | Experimental | Treatment group Receives: Drug: AP301 |
| saline solution | Placebo comparator | Placebo group Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in extravascular lung water within 7 days of treatment
EVWL (measured with PiCCO® technique) until day 7 of treatment (AUC)
Measured: change from baseline - day 7
Secondary outcomes (5)
Oxygenation index
Oxygenation index (PaO2 / FiO2 ratio) until day 7 of treatment
Measured: baseline - day 7
ventilator plateau pressure
Ventilator plateau pressure until day 7 of treatment
Measured: baseline - day 7
Murray Lung Injury Score
Measured: baseline - day 7
Ventilation parameters / lung function
Measured: baseline - day 7
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))
Measured: baseline - day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apeptico Forschung und Entwicklung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Ullrich, Prof., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627613
- Sponsor's protocol ID
- AP301-II-001
- Other IDs
- 2012-001863-64
- Status last verified
- Nov 2019
- First submitted
- 20 Jun 2012
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28750677
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01627613
- Acronym / sponsor ID
- AP301-II-001
- Conditions
- Acute Lung Injury
- Keywords
- Peptide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Apeptico Forschung und Entwicklung GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP301 | Experimental | Drug: AP301Treatment group |
| saline solution | Placebo comparator | Drug: Saline solutionPlacebo group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP301AP301 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 | AP301 |
| Saline solutionPlacebo solution (0.9% physiologic NaCl) is inhaled every 12 hours (± 30 min), for a total of 7 days. | Drug | saline solution |
Primary outcome
change in extravascular lung water within 7 days of treatment
Time frame: change from baseline - day 7
EVWL (measured with PiCCO® technique) until day 7 of treatment (AUC)
5 secondary outcomes
Oxygenation index
Time frame: baseline - day 7
ventilator plateau pressure
Time frame: baseline - day 7
Murray Lung Injury Score
Time frame: baseline - day 7
Ventilation parameters / lung function
Time frame: baseline - day 7
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Derived from this study: PubMed 28750677Krenn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Ullrich, Prof. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP301 and Saline solution in people with Acute Lung Injury, run by Apeptico Forschung und Entwicklung GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in extravascular lung water within 7 days of treatment (time frame: change from baseline - day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01627613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.