Nontuberculous mycobacterial lung disease respiratory infection
Conditions
Interventions
1) Dosage
High dosage group: Sargramostim 250 microgram at a time, twice a day
Intermediate dosage group: Sargramostim 125 microgram at a time, twice a day
Low dosage group: Sargramostim 125 microgram
D012138
Sponsors
Kikuchi Toshiaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the conditions below: 1. Age 20 or more at the time of obtaining informed consent, regardless of gender 2. Information about the name and condition of the disease is appropriately provided in advance 3. Ability to understand the explanation of this trial and give written voluntary consent 4. Meet the diagnostic criteria of nontuberculous mycobacterial lung disease. , , and Mycobacterium avium or M. intracellulare is detected in sputum twice within 2 years. 5. Meet a) or b) below: a) Sustained positive mycobacterial culture test after chemotherapy against nontuberculous mycobacterial lung disease for 6 months or more. b) Withdrawal of chemotherapy against nontuberculous mycobacterial lung disease due to insufficient effectiveness or adverse effects 28 days or more before assessment for eligibility
Exclusion criteria
Exclusion criteria: Subjects meeting one or more conditions below: 1. 12000/mm3 or more of WBC on enrollment 2. Previously treated with GM-CSF inhalation 3. 60 ml or more per 24 hours of Hemoptysis within 4 weeks 4. Cardiovascular diseases, congestive heart failure/angina pectoris/hemorrhagic diathesis etc., with severe symptoms 5. History of malignant tumor with in 5 years except treated uterine carcinoma in situ and local basal cell carcinoma 6. Systemic corticosteroid therapy with 10 mg/day or more on a prednisolone conversion basis within 3 months or the therapy is expected during this trial 7. Change of chemotherapy regimen against nontuberculous mycobacterial lung disease wihtin 28 days 8. Pregnancy, breast-feeding, or desire for childbearing during this trial 9. Liver dysfunction 10. Renal dysfunction 11. History of severe or unexplainable adverse effect by inhalatoin therapy 12. Incapable of informed consent, subject whose informed consent may not be voluntary 13. Ineligible for this trial at the medical discretion of the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients who show negative mycobacterial culture test in sputume 3 times in a row after initiation of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients who show negative mycobacterial culture test in sputum after initiation of intervention at 12-week and 16-week in a row or at 16-week 2. Improvement in mycobacterial smear test in sputum at 4, 8, 12, and 16-week from baseline 3. Change in QOL score at 16-week from baseline 4. Improvement in chest radiograph 5. Change in anti-GM-CSF antibody titer 6. Change in serum cytokine levels | — |
Contacts
Public ContactKenjiro Shima
Niigata University Medical & Dental Hospital
Outcome results
None listed