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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: Pirfenidone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent signed; Age ≤75 years; Clinically or multidisciplinary diagnosed idiopathic pulmonary fibrosis(see 2011 guidance ); Resting state PaO2≥50mg, FVC%≥45% normal predicted value and DLCO≥30% normal predicted value. Exclusion Criteria: Allergic to pirfenidone; Patients with serious Significant pulmonary infection need anti-infection treatment; Patients who has taken interferon, penicillamine or other agents for the treatment of IPF; Patients who has taken prednisone(≥50mg) or other glucocorticoid in the past 1 month; Patients who has taken immunosuppressants in the past 1 month; Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months; Patients with malignant tumor in the past 5 years; Participated in other clinical trials in the past 3 months; 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); Pregnant or lactating women; The investigator assessed as inappropriate to participate in this clinical trial.

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (without active ingredient)<br>placebo will be taken two tablets 3 times a day during the whole study process. | Drug: Pirfenidone<br>* Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.<br>Drug: placebo<br>* placebo will be taken two tablets 3 times a day during the whole study process<br>|
| Experimental: Pirfenidone（200mg）<br>Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process. | Drug: Pirfenidone<br>* Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.<br>Drug: placebo<br>* placebo will be taken two tablets 3 times a day during the whole study process<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in forced vital capacity (FVC) | to evaluate changes in FVC from baseline to 12 weeks /24 weeks/36 weeks/48 weeks | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in lung function (including Forced expiratory volume in one second (FEV1) and The differences of diffusing capacity of the lung for carbon monoxide (DLco) ) | Lung function will be measured as improved/stabilized/exacerbated from baseline to 12 weeks/24 weeks/36 weeks/48 weeks | 48week | 
| Changes in 6 minute walk distance (6MWD) | Changes in 6 minute walk distance (6MWD) and from baseline to 12/24/36/48weeks | 48 weeks | 
| Life quality: assessed by St. George respiratory questionnaire (SGRQ). | Life quality will be assessed as improved if SGRQ single or total score increased >4% when completing the trial; Life quality will be assessed as stabilized if SGRQ single or total score changes within the range of 4% when completing the trial; Life quality will be assessed as exacerbated if SGRQ single or total score decreased >4% when completing the trial. | 48 weeks | 
| Dyspnea score according by Modified Medical Research Center(MMRC) | to measure rating dyspnea according by Medi Medical Research Center(MMRC) | 48 weeks |