Respiratory Distress Syndrome, AdultPhase 3ThIloNCT03111212
Iloprost in Acute Respiratory Distress Syndrome
A Phase 3 study testing Iloprost in people with Respiratory Distress Syndrome, Adult, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The patients will be randomized into one of two groups. Both groups will receive standard care as is state of the art. The intervention group will receive Iloprost nebulized as inhalative therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Iloprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jun 2019to 14 Aug 2021
- Phase
- Phase 3
- 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
- Horowitz index <300
- Bilateral opacities on frontal chest radiograph
- requirement of positive pressure ventilation
- no clinical evidence of left atrial hypertension
- enrollment within 48h of onset of ARDS
- mechanical ventilation <7 days
Who cannot join
- age <18 years
- mechanical ventilation >7 days
- patient, surrogate or physician not committed to full intensive care support
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)
The patients will be randomized into one of two groups. Both groups will receive standard care as is state of the art. The intervention group will receive Iloprost nebulized as inhalative therapy.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Iloprost, control
- Keywords
- Acute respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
Iloprost nebulized
controlDrug
sodium chloride 0,9% nebulized
| Study group | Role | What they receive |
|---|---|---|
| Iloprost | Active comparator | Not described Receives: Drug: Iloprost |
| control | Placebo comparator | Not described Receives: Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2
partial pressure of oxygen in blood (PaO2), in millimeters of mercury divided by the fraction of oxygen in the inhaled air (FiO2)
Measured: Day 6 of Study
Secondary outcomes (11)
Overall survival in 90-day follow-up period
90 day all cause mortality
Measured: on day 90 after randomization and study entry
Sequential Organ Failure Assessment Score (SOFA Score)
The SOFA score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is assessed by 0=normal function to max 4 points=severe organ dysfunction Lowest Score is 0, the Maximums Score is 24; high Scores mean worse outcome
Measured: until ICU discharge, estimated average = 14 days
Duration of Mechanical Ventilation
Ventilation Support length
Measured: until ICU discharge, estimated average = 14 days
Number of Patients with the Occurence of Barotrauma
Barotrauma is damage to body tissue secondary to pressure difference in enclosed cavities within the body.Ventilator asynchrony, acute elevation of the plateau and peak pressures above 30 cmH2O, or sudden decrease of delivered tidal volume are result of barotrauma.
Measured: until ICU discharge, estimated average = 14 days
Number of Patients with Pulmonary Hemorrhage
Significant Bleeding from Lung
Measured: until ICU discharge, estimated average = 14 days
Number of Patients with Gastrointestinal Hemorrhage
Significant Bleeding from GI Tract
Measured: until ICU discharge, estimated average = 14 days
Number of Patients with Pulmonary Embolism
Blockage of an artery in the lungs by a embolus that has moved from elsewhere in the body to the lung
Measured: until ICU discharge, estimated average = 14 days
Number of Patients with Delirium
An organically caused decline from a previous baseline mental functioning, that develops over a short period of time, typically hours to days. Measured as occurence and length in time.
Measured: until ICU discharge, estimated average = 14 days
Number of Patients with ICU Acquired Weakness
Skeletal muscle dysfunction
Measured: until ICU discharge, estimated average = 14 days
Discharge Location
Number of Patients discharged to home without additional care (self-care), home with additional care (home health care) and other care facilities such as nursing homes. Measured as % of patients discharged to either of these locations.
Measured: until ICU discharge, estimated average = 14 days
Barthel Index (BI)
Is a measure using an ordinal scale used to measure performance in activities of daily living (ADL). The original 10-item form of the BI consists of 10 common ADL activities including: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Items are rated in terms of whether individuals can perform activities independently, with some assistance, or are dependent (scored as 10, 5 or 0). Items are weighted according to the level of nursing care required.
Measured: at 6 months after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start25 Jun 2019
- Primary completion14 May 2021
- Study completion14 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rosenberger, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111212
- Sponsor's protocol ID
- ThIlo
- Acronym
- ThIlo
- Status last verified
- Jun 2021
- First submitted
- 6 Apr 2017
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bernard A, Serna-Higuita LM, Althaus K, Rosenberger P, Vohringer R, Korner A, Haeberle H, Eggstein C, Bakchoul T, Margraf A, Fodi C, Zarbock A, Koeppen M, Mirakaj V. Diminished plasma levels of GPIb-alpha predict mortality in a prospective ARDS cohort. Front Med (Lausanne). 2026 Apr 24;13:1711751. doi: 10.3389/fmed.2026.1711751. eCollection 2026.
PubMed 42110435Haeberle HA, Calov S, Martus P, Serna-Higuita LM, Koeppen M, Goll A, Bernard A, Zarbock A, Meersch M, Weiss R, Mehrlander M, Marx G, Putensen C, Bakchoul T, Magunia H, Nieswandt B, Mirakaj V, Rosenberger P. Inhaled prostacyclin therapy in the acute respiratory distress syndrome: a randomized controlled multicenter trial. Respir Res. 2023 Feb 18;24(1):58. doi: 10.1186/s12931-023-02346-0.
PubMed 36805707Haeberle H, Prohaska S, Martus P, Straub A, Zarbock A, Marx G, Zago M, Giera M, Koeppen M, Rosenberger P. Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study. Trials. 2020 Mar 4;21(1):242. doi: 10.1186/s13063-020-4163-0.
PubMed 32131881
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)
- ClinicalTrials.gov ID
- NCT03111212
- Acronym / sponsor ID
- ThIlo / ThIlo
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Acute respiratory distress syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 Aug 2021 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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 patients will be randomized into one of two groups. Both groups will receive standard care as is state of the art. The intervention group will receive Iloprost nebulized as inhalative therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iloprost | Active comparator | Drug: Iloprost |
| control | Placebo comparator | Drug: control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Horowitz index <300
- Bilateral opacities on frontal chest radiograph
- requirement of positive pressure ventilation
- no clinical evidence of left atrial hypertension
- enrollment within 48h of onset of ARDS
Key exclusion criteria (4 listed)
- age <18 years
- mechanical ventilation >7 days
- patient, surrogate or physician not committed to full intensive care support
- pregnancy
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 |
|---|---|---|
| IloprostIloprost nebulized | Drug | Iloprost |
| controlsodium chloride 0,9% nebulized | Drug | control |
Primary outcome
Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2
Time frame: Day 6 of Study
partial pressure of oxygen in blood (PaO2), in millimeters of mercury divided by the fraction of oxygen in the inhaled air (FiO2)
11 secondary outcomes
Overall survival in 90-day follow-up period
Time frame: on day 90 after randomization and study entry
Sequential Organ Failure Assessment Score (SOFA Score)
Time frame: until ICU discharge, estimated average = 14 days
Duration of Mechanical Ventilation
Time frame: until ICU discharge, estimated average = 14 days
Number of Patients with the Occurence of Barotrauma
Time frame: until ICU discharge, estimated average = 14 days
Number of Patients with Pulmonary Hemorrhage
Time frame: until ICU discharge, estimated average = 14 days
Number of Patients with Gastrointestinal Hemorrhage
Time frame: until ICU discharge, estimated average = 14 days
Number of Patients with Pulmonary Embolism
Time frame: until ICU discharge, estimated average = 14 days
Number of Patients with Delirium
Time frame: until ICU discharge, estimated average = 14 days
Number of Patients with ICU Acquired Weakness
Time frame: until ICU discharge, estimated average = 14 days
Discharge Location
Time frame: until ICU discharge, estimated average = 14 days
Barthel Index (BI)
Time frame: at 6 months after study inclusion
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 30 Dec 2021.
- Derived from this study: PubMed 42110435Bernard A, Serna-Higuita LM, Althaus K, Rosenberger P, Vohringer R, Korner A, Haeberle H, Eggstein C, Bakchoul T, Margraf A, Fodi C, Zarbock A, Koeppen M, Mirakaj V. Diminished plasma levels of GPIb-alpha predict mortality in a prospective ARDS cohort. Front Med (Lausanne). 2026 Apr 24;13:1711751. doi: 10.3389/fmed.2026.1711751. eCollection 2026.
- Derived from this study: PubMed 36805707Haeberle HA, Calov S, Martus P, Serna-Higuita LM, Koeppen M, Goll A, Bernard A, Zarbock A, Meersch M, Weiss R, Mehrlander M, Marx G, Putensen C, Bakchoul T, Magunia H, Nieswandt B, Mirakaj V, Rosenberger P. Inhaled prostacyclin therapy in the acute respiratory distress syndrome: a randomized controlled multicenter trial. Respir Res. 2023 Feb 18;24(1):58. doi: 10.1186/s12931-023-02346-0.
- Derived from this study: PubMed 32131881Haeberle H, Prohaska S, Martus P, Straub A, Zarbock A, Marx G, Zago M, Giera M, Koeppen M, Rosenberger P. Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study. Trials. 2020 Mar 4;21(1):242. doi: 10.1186/s13063-020-4163-0.
- Individual participant dataSharing planned: Undecided
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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.
Peter Rosenberger, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iloprost in people with Respiratory Distress Syndrome, Adult, run by University Hospital Tuebingen at 1 site in Germany.
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 6 inclusion and 4 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 30 Dec 2021. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2 (time frame: Day 6 of Study). 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 NCT03111212, which also lists 3 linked publications.
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 30 Dec 2021.