Study of Subcutaneous Injection of Low-dose rhGM-CSF +/- WLL in PAP.
NCT ID: NCT01983657
Last Updated: 2013-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2012-01-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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D1
Patients diagnosed with PAP will be received rhGM-CSF 1.25 ug/kg/d subcutaneously for 1 month, before evaluation on the 30th day (±3 day).
If the treatment is effective, participants may be entered into low-dose group(D1)(rhGM-CSF administration 1.25 ug/kg/d, qd, sc, for 2 months，then rhGM-CSF administration 1.25 ug/kg/d, qod, sc, for 3 months), when the chest CT absorption≥25% , and /or the PaO2 elevated by 5 mm Hg.
rhGM-CSF
GM-CSF will be given subcutaneously according to the rule in different groups.
D2
Patients diagnosed with PAP will be received rhGM-CSF 1.25 ug/kg/d subcutaneously for 1 month, before evaluation on the 30th day (±3 day).
When the treatment is ineffective, and anti-GM-CSF antibody titers level ≥1:1000，the dose will be increased to 2.5 ug/kg/d. After 2 months, if the clinical response was optimal, that dose is continued for 3 months, and defined as group 2(D2).
rhGM-CSF
GM-CSF will be given subcutaneously according to the rule in different groups.
D3
Patients diagnosed with PAP will be received rhGM-CSF 1.25 ug/kg/d subcutaneously for 1 month, before evaluation on the 30th day (±3 day).
When the treatment is ineffective, and anti-GM-CSF antibody titers level ≥1:1000，the dose will be increased to 2.5 ug/kg/d. After 2 months, if the clinical response was not optimal, the patients will receive whole lung lavage(WLL), who are defined as group 3(D3).
rhGM-CSF
GM-CSF will be given subcutaneously according to the rule in different groups.
D4
Patients diagnosed with PAP will be received rhGM-CSF 1.25 ug/kg/d subcutaneously for 1 month, before evaluation on the 30th day (±3 day).
When the treatment is ineffective, and anti-GM-CSF antibody titers level \<1:1000，the patients will receive whole lung lavage(WLL), then give rhGM-CSF administration (1.25 ug/kg/d) for 3 months, which belong to group4(D4).
rhGM-CSF
GM-CSF will be given subcutaneously according to the rule in different groups.
Whole Lung Lavage(WLL)
using double lumen endotracheal tube (DLT) to selectively lavage one lung
Interventions
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rhGM-CSF
GM-CSF will be given subcutaneously according to the rule in different groups.
Whole Lung Lavage(WLL)
using double lumen endotracheal tube (DLT) to selectively lavage one lung
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 17-80
* Signed informed consent
Exclusion Criteria
* Received whole lung lavage therapy within 4 weeks before enrollment
* Received previous GM-CSF therapy within 6 months before enrollment
* WBC≥12,000/ul
* fever≥38℃
* Severe edema, severe liver, kidney, lung and cardiovascular disease.
* Pregnant，planning to get pregnant or nursing
* Inability to express the subjective discomfort
* Serious drug allergy history, E.coli preparation or rhGM-CSF serious allergy history
17 Years
80 Years
ALL
No
Sponsors
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Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Huiping Li
Professor,Chief of Dept. of Respiratory Medicine
Principal Investigators
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Huiping Li, Dr
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China
Locations
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Shanghai Pulmonary Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Huiping Li, Doctor
Role: primary
References
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Zhang F, Weng D, Su Y, Yin C, Shen L, Zhang Y, Zhou Y, Li Q, Hu Y, Li H. Therapeutic effect of subcutaneous injection of low dose recombinant human granulocyte-macrophage colony-stimulating factor on pulmonary alveolar proteinosis. Respir Res. 2020 Jan 2;21(1):1. doi: 10.1186/s12931-019-1261-1.
Other Identifiers
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20120401
Identifier Type: -
Identifier Source: org_study_id