Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Lecithinized Superoxide Dismutase Nebulizer (PC-SOD NE) in Adult Patients with Moderate Idiopathic Pulmonary Fibrosis
- Conditions
- idiopathic pulmonary fibrosis
- Registration Number
- JPRN-UMIN000009572
- Lead Sponsor
- TT Bio-Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 96
Not provided
1) Exclusion criteria involving similar diseases (1)Patients who's IPF was clearly caused by pharmaceuticals (2)Patients diagnosed with asthma or chronic obstructive pulmonary disease (COPD) FEV1% <70% or Patients who are diagnosed with severe COPD from the HRCT image (3)Patients diagnosed with a pulmonary or respiratory infection that may affect the efficacy of the study drug 2) Exclusion criteria due to previous treatment (1)Patients who started to use steroids or changed the dose of the steroid within 4 weeks prior to the study drug administration. (2)Patients who used immunosuppressants , pirfenidone, N-acetylcysteine or steroids within 4 weeks prior to study drug administration (on the other hand, those who stop these drugs for any reason and have a washout period of >=4 weeks can be enrolled). 3) Exclusion criteria due to potential safety issues (1)Patients having Grade 4 hepatic, renal, or digestive disorders (2)Patients who have complicated ≥ Grade 4 hematologic disorders or cardiovascular diseases (3)Patients who have complicated malignant neoplasm such as cancer or tumor occurring within 5 years before enrollment, however, patients with a history of lung cancer cannot enroll. (4)Patients who are pregnant or possibly pregnant, or nursing (5)Patients who participated in another clinical study within 4 months prior to the administration period of the study drug (6)Patients who have a drug dependency or a history of drug abuse (7)Patients who are current smokers (8)Patients are sensitive to any drugs (all drugs prescribed or commercially available drugs) or have history of sensitivity to the drugs (9)Patients who have taken PC-SOD or PC-SOD NE previously in their medical history (10) Patients determined for other reasons not to be suitable to enter the current clinical study safely by the PI or subinvestigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline of forced vital capacity (FVC).
- Secondary Outcome Measures
Name Time Method (1) FVC (rate of change), %FVC (change from baseline and rate of change), VC (change from baseline and rate of change), %VC (change from baseline and rate of change), total lung capacity (TLC) (change from baseline and rate of change), diffusing lung function (%DLco) (change from baseline and rate of change), SpO2 at rest (change from baseline and rate of change). (2) Change from baseline and rate of change of pulmonary fibrosis markers. (3) Activities of daily living (ADL). (4) Acute exacerbations. (5) Deterioration of FVC. (6) Deterioration of SpO2. (7) Survival rate: Overall survival rate and death from a respiratory cause. (8) Progression free survival (PFS)