Study on host immune response during treatment of patients with pulmonary nontuberculous mycobacterial disease
- Conditions
- pulmonary nontuberculous mycobacterial disease
- Registration Number
- JPRN-UMIN000049658
- Lead Sponsor
- Department of Respiratory Medicine, University of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
1. Comorbid respiratory disease: presence of any existing clinically significant known respiratory disease other than pulmonary NTM disease. 2. Malignancy: current malignancy or history of cancer that has just gone into remission less than 12 months prior to entry. 3. Liver disease: known pre-existing unstable liver disease. 4. Cardiovascular: Patients with severe or clinically significant cardiovascular disease that cannot be controlled with standard therapy. 5. Other co-morbidities: patients with known clinically significant endocrine, autoimmune, metabolic, neurologic, renal, gastrointestinal, hepatic, or hematologic disease that cannot be controlled with standard therapy. patients receiving systemic steroids for more than 4 weeks. However, patients receiving prednisolone equivalent of 10 mg/day or less of steroids will be subject to observation. 6. Pregnancy: subjects who are pregnant or lactating.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is to identify the gene expression profiles in whole blood cells and serum proteins that predict the response to treatment in pulmonary NTM patients, who will be divided into a treatment (CAM+EB+RFP or EM) response group and a treatment non-response group during a 1-year observation period. Then, the validity of the biomarker will be clarified in relation to the clinical information.
- Secondary Outcome Measures
Name Time Method The secondary endpoints of this study are to determine the effect of treatment (CAM/AZM+EB+RFP or EM) on pulmonary NTM disease by comparing the pre-treatment samples and post-treatment samples in terms of the gene expression in whole blood cells and serum protein levels. RNA-seq in this study will be performed at the University of Tsukuba.