idiopathic pulmonary fibrosis
Conditions
Interventions
PC-SOD NE was repeatedly inhaled once daily for 7 days at doses of 10 mg ( step 1 ) or 20 mg ( step 2 ), or once daily for 14 days at a dose of 40 mg ( step 3 ).
Placebo was repeatedly inhaled once da
Sponsors
LTT Bio Pharma Co., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Sex:Male or Female (2)Age:20-80 years (3)Japanese (4)Patients diagnosed as IIP by X-ray and HCRT (5) LDH 350U/L<= SP-A 65ng/mL<= (6)All patients must provide written informed consent (7)Patients who the principal Investigator or the investigator judges medically suitable for inclusion in the clinical investigation based on examination at screening conduceted within 28days prior to study drug administration
Exclusion criteria
Exclusion criteria: (1)Exclusion criteria involving similar diseases 1.Patients who's IPF was clearly caused by pharmaceuticals 2.Patients diagnosed with COPD or asthma or airway infection (2)Exclusion criteria due to previous treatment (3)Patients who are moderate intake of alcohol or alcoholics (4)Patients of chemical dependency (5)Patients who are smokers within a month(6)Patients are sensitive to any drugs (alldrugs prescribed or commercially available drugs) or have history of sensitivity to the drugs (7)Before 4 wee (8)Patients who participated in another clinical study within 4 months prior to the administration period of the study drug (9)Patients who are pregnant or possibly pregnant, or nursing (10)Patients who have taken PC-SOD previously in their medical history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)Safety Adverse event subjective, objective weight vital signs 12-lead electrocardiogram lung function test Clinical test antibody titer in blood of PC-SOD (2)Pharmacological effect Biomarker(LDH, SP-A, SP-D, KL-6) (3)Pharmacokinetics blood serum concentration of PC-SOD | — |
Countries
Japan
Outcome results
None listed