idiopathic pulmonary fibrosis
Conditions
Interventions
(PC-SOD NE 20-mg group)One vial containing 20-mg of PC-SOD NE, that is PC-SOD NE for inhalation via a nebulizer. (Timing of administration)Study drug is administered in nebulized form once daily. (Ad
Sponsors
LTT Bio-Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with IPF according to the guidelines and according to criteria established by the American Thoracic Society (ATS) 4 based on high-resolution computed tomography (HRCT) images. (2)Patients with a percentage of predicted forced vital capacity (FVC) at screening of >60%. (3)Patients with a percentage of predicted carbon monoxide diffusing capacity (DLco) at screening of >40%. (4)Patients whose FVC levels were reduced by >=5% within 12 months prior to the screening point, except during its acute exacerbation. (5)Sex: Male or female. (6)Age: 20-80 years (when informed consent is received), both inclusive. (7)Willing to use contraception: Female patients must be postmenopausal (for at least the past 12 months), surgically sterile, or have a negative urine pregnancy test at entry into the study. The patient must use maximally effective birth control during the course of the study, and be willing to use contraception for 6 months following the last study drug administration. Male patients must be either surgically sterile or willing to use a barrier contraception method upon enrollment, during the course of the study, and for 6 months following the last study drug administration. (8)All patients must be able to read, understand, and provide written voluntary informed consent on the Institutional Review Board (IRB)/ Ethics Committee(EC) approved ICF and provide authorization as appropriate for local privacy regulations. (9)Patients who are able and willing to comply with all treatment and follow-up procedures.
Exclusion criteria
Exclusion criteria: 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 &#8805; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of forced vital capacity (FVC). | — |
Secondary
| Measure | Time frame |
|---|---|
| (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) | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactTohru Mizushima, Ph D
LTT Bio-Pharma Co., Ltd. Chairman of the Board of Directors
Outcome results
None listed