Inhalation of Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Autoimmune Pulmonary … (NCT02243228) | Clinical Trial Compass
UnknownPhase 2
Inhalation of Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Autoimmune Pulmonary Alveolar Proteinosis (PAP)
China42 participantsStarted 2014-08
Plain-language summary
The purpose of the study is to evaluate if inhaled granulocyte-macrophage colony stimulating factor delay the increase in alveolar-arterial oxygen difference, compared to no treatment, for adult patients with mild-to-moderate autoimmune pulmonary alveolar proteinosis in China over a two-year period.
Who can participate
Age range18 Years
SexALL
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Accessible population:
Adult patients with mild-to-moderate autoimmune pulmonary alveolar and without spontaneous remission will be enrolled at Peking Union Medical College Hospital and Nanjing Drum Tower Hospital.
Inclusion Criteria:
* Adult autoimmune PAP subjects will be included: 1) a positive PAS stain from BALF or lung biopsy; 2) high level of serum anti-GM-CSF antibody (\>2.39ug/ml, the cut-off point in our hospital); 3) age above 18 years old; 4) exclude hereditary and secondary PAP.
* Able to give written informed consent and comply with the requirements of the study.
* Patients are not eligible for the whole lung lavage (WLL), decided by clinicians.
* Eligibility for GM-CSF inhalation: 1) Disease severity score (DSS) is 1-3; 2) No treatment with GM-CSF therapy or WLLin the 3 months prior to enrollment. Definition of DSS2: 1, no symptom and PaO2\>=70mmHg；2, PaO2\>=70mmHg with symptoms；3, PaO2\>=60 and \<70mmHg; 4, PaO2\>=50 and \<60mmHg; 5, PaO2\<50mmHg.
Exclusion Criteria:
* Patients will be observed for 3 months and all APAP patients who resolved spontaneously will be excluded from our study.
* PAP resulting from another condition (e.g. occupational exposure to silica, underlying HIV, respiratory infections, myeloproliferative disorder or leukaemia);
* A normal or low-titre serum anti-GM-CSF antibody (≤2.39ug/ml);
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies；
* Chronic lung disease associated with already …