GM-CSF Inhalation to improve HOst defense and Pulmonary barrier rEstoratio

Phase 1

• Conditions: Pneumonia associated Acute Respiratory Distress Syndrome (ARDS); MedDRA version: 20.0Level: LLTClassification code 10000036Term: A.R.D.S.System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-002479-28-DE
• Lead Sponsor: Justus-Liebig University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-15
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

All of the following inclusion criteria must be met before the patient can enter into the trial:
1. Signed informed consent form by the patient or a legal representative according to local regulations
2. Man or woman 18 to 75 years of age, inclusive
3. Women who have been post-menopausal for more than 1 year or women of childbearing potential using a highly efficient method of contraception (i.e. a method with less than 1% failure rate such as combined hormonal contraception, progesterone-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tube occlusion, vasectomized partner, sexual abstinence) during dosing and hospitalisation. Women must have a negative serum or urine pregnancy test before the first dose of study medication and must not be lactating.
4. Diagnosis of pneumonia-associated ARDS where the underlying condition is Community-Acquired Pneumonia (CAP) or Hospital-Acquired Pneumonia (HAP) in patients not on invasive ventilation upon diagnosis of HAP
5. Diagnosis of ARDS according to the Berlin ARDS definition (The ARDS definition task force) as evidenced by:
a. onset within 1 week of a known clinical insult or new or worsening respiratory symptoms
b. bilateral opacities on chest imaging, in the investigator’s opinion not fully explained by
effusions, lobar/lung collapse, or nodules,
c. respiratory failure in the investigator’s opinion not fully explained by cardiac failure or fluid
overload
d. PaO2/FIO2 =300 mmHg with PEEP =5 cm H2O
6. Requirement for positive pressure ventilation (non-invasive or via endotracheal tube) for more than 72 hours in total with FiO2 = 50% (or less when on additional ECMO) not longer than 14 days

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Receiving vasopressors of >100 µg/min
2. History of liver cirrhosis Child Pugh C, chronic hemodialysis (before severe pneumonia/ARDS), lung cancer
3. Malignancy with expected survival time of less than 6 months
4. History of, or listing for lung transplantation
5. Highly immunosuppressive therapy or anti-malignant combination chemotherapy within 3 weeks prior to first dose of study drug
6. Any anti-malignant chemotherapy within 24 hours prior to first dose of study drug
7. AIDS or known history of HIV infection
8. Pregnancy
9. Autoimmune thrombocytopenia, myelodysplastic syndromes with > 20% marrow blast cells
10. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim or to related compounds (i.e., Growgen®, Leucomax®, Leukine™, Topleucon™)
11. Participation in another clinical trial within 90 days prior to the first dose of study drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified