Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Pirfenidone; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02136992

SPH01312

Details and patient eligibility

About

Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti- fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and safety evaluation in china. The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases.

Full description

The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases. During the observation, study visits will occur at the end of 12w, 24w, 36w, 48w.all participants will be required to check the various efficacy and safety indicators.

Enrollment: 160 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent signed;
2. Age ≤75 years;
3. Clinically or multidisciplinary diagnosed idiopathic pulmonary fibrosis(see 2011 guidance );
4. Resting state PaO2≥50mg, FVC%≥45% normal predicted value and DLCO≥30% normal predicted value.

Exclusion criteria

1. Allergic to pirfenidone;
2. Patients with serious Significant pulmonary infection need anti-infection treatment;
3. Patients who has taken interferon, penicillamine or other agents for the treatment of IPF;
4. Patients who has taken prednisone(≥50mg) or other glucocorticoid in the past 1 month;
5. Patients who has taken immunosuppressants in the past 1 month;
6. Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
7. Patients with malignant tumor in the past 5 years;
8. Participated in other clinical trials in the past 3 months;
9. Patients with serious heart disease(NYHA class Ⅲ-Ⅳ), liver disease(ALT or AST 2 times above the upper level of normal value range), kidney disease(Cr above the upper level of normal value range);
10. Pregnant or lactating women;
11. The investigator assessed as inappropriate to participate in this clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

Placebo (without active ingredient)

Placebo Comparator group

Description:

placebo will be taken two tablets 3 times a day during the whole study process.

Treatment:

Drug: Pirfenidone

Drug: placebo

Pirfenidone（200mg）

Experimental group

Description:

Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.

Treatment:

Drug: Pirfenidone

Drug: placebo