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

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Pirfenidone; Drug: placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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
Dyspnea score according by Modified Medical Research Center(MMRC)	to measure rating dyspnea according by Medi Medical Research Center(MMRC)	48 weeks

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Collaborators: Nanjing Chia-tai Tianqing Pharmaceutical
• Investigators: Principal Investigator: Huiping Li, Shanghai Pulmonary Hospital , Tongji University

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 11, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Estimate): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Pirfenidone
• Other Study ID Numbers: SPH01312