Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030056
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
2002-01-30
Brief Title:
GM-CSF in Patients With Pulmonary Alveolar Proteinosis
Sponsor:
The Cleveland Clinic
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Trial of GM-CSF for Alveolar Proteinosis
Status:
TERMINATED
Status Verified Date:
2002-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to determine the efficacy and safety of granulocyte-macrophage colony-stimulating factor GM-CSF sargramostim administered subcutaneously to patients with pulmonary alveolar proteinosis PAP
Detailed Description:
PAP is a rare lung disease characterized by accumulation of surfactant phospholipids and proteins within the lungs There is no specific pharmacologic therapy for PAP and the current practice of lung lavage under general anesthesia is invasive and has limitations Although it is unknown if the anti GM-CSF antibody is related to the disease pathogenesis observations suggest a role for GM-CSF in lung homeostasis as well as in the pathogenesis of PAP
Patients will receive subcutaneous GM-CSF or placebo once a day and will be followed on an outpatient basis at 2 weeks and 1 2 3 4 5 and 6 months after initiation of therapy Clinical response will determine dosing schedule and will be evaluated by symptom scores gas exchange data and chest radiographs
Completion date provided represents the completion date of the grant per OOPD records
Patients will receive subcutaneous GM-CSF or placebo once a day and will be followed on an outpatient basis at 2 weeks and 1 2 3 4 5 and 6 months after initiation of therapy Clinical response will determine dosing schedule and will be evaluated by symptom scores gas exchange data and chest radiographs
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-002016-01 | None | None | None |