The tuberculosis treatments by anti-tuberculosis dry powder prepared as nano-particulate system for inhaling into the respiratory system
Phase 2
Recruiting
- Conditions
- patient with pulmonary tuberculosispulmonary tuberculosis treatment,dry powder inhaler
- Registration Number
- TCTR20190404002
- Lead Sponsor
- Government Pharmaceutical Organization (GPO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 208
Inclusion Criteria
new case and retreatment pulmonary tuberculosis, sputum AFB positive, have clinical symptoms of TB (cough > 3 week, lose weight, night sweat, abnormal film CXR), comply to clinical trial, mono resistant pulmonary TB
Exclusion Criteria
pregnancy and breast feeding, MDR TB, estimate peak expiratory flow rate > 60 L/min, ALT>125 U/L, HIV sero positive, allergy to research drugs, uncontrol asthma, copd, drug addict, use fluoroquinolone with in 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy, sputum culture conversion 8 weeks positive or negative,sputum culture conversion 8 weeks positive or negative
- Secondary Outcome Measures
Name Time Method Safety, Liverfunction test, serum uric acid , clinical of adverse reaction of oral treat and DPI 2 month 6 month level of AST, ALT, tB, dB, ALK , interview