Trials / Completed
CompletedNCT02595060
Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) Inhalation to Improve Host Defense and Pulmonary Barrier Restoration
GM-CSF Inhalation to Improve Host Defense and Pulmonary Barrier Restoration (GI-HOPE). A Randomized, Double-blind, Parallel Group, Multicenter, Phase II Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- University of Giessen · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This trial evaluates efficacy and safety of inhaled molgramostim (rhGM-CSF) in 45 patients with pneumonia associated acute respiratory distress syndrome (ARDS). A third of the patients will receive 150 mcg inhaled molgramostim, another third 450 mcg and the remaining third will receive inhaled placebo for 3 days. The patients will be followed for 28 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | inhaled molgramostim (rhGM-CSF) | |
| DRUG | inhaled placebo | formulated as the active substance without molgramostim |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2021-09-22
- Completion
- 2022-07-31
- First posted
- 2015-11-03
- Last updated
- 2023-08-31
Locations
7 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02595060. Inclusion in this directory is not an endorsement.