GM-CSF Inhalation for Nontuberculous Mycobacterial Lung Disease Pilot Trial

Phase 2

• Conditions: ontuberculous mycobacterial lung disease; respiratory infection; D009165

• Registration Number: JPRN-jRCTs031210062
• Lead Sponsor: Kikuchi Toshiaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-30
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified