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

Phase 2

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Pirfenidone; Drug: placebo

• Registration Number: NCT02136992
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

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

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 Timeline

• Study Start: 2011-12
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2014-05
• Study First Submitted: 2014-05-11
• Study First Submitted QC: 2014-05-12
• Last Update Submitted: 2014-05-12
• Study First Posted: 2014-05-13
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pirfenidone（200mg）	placebo	Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.
Placebo (without active ingredient)	placebo	placebo will be taken two tablets 3 times a day during the whole study process.
Placebo (without active ingredient)	Pirfenidone	placebo will be taken two tablets 3 times a day during the whole study process.
Pirfenidone（200mg）	Pirfenidone	Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.

Primary Outcome Measures

Name	Time	Method
Changes in forced vital capacity (FVC)	48 weeks	to evaluate changes in FVC from baseline to 12 weeks /24 weeks/36 weeks/48 weeks

Secondary Outcome Measures

Name	Time	Method
Dyspnea score according by Modified Medical Research Center(MMRC)	48 weeks	to measure rating dyspnea according by Medi Medical Research Center(MMRC)
Changes in 6 minute walk distance (6MWD)	48 weeks	Changes in 6 minute walk distance (6MWD) and from baseline to 12/24/36/48weeks
Life quality: assessed by St. George respiratory questionnaire (SGRQ).	48 weeks	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.
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) )	48week	Lung function will be measured as improved/stabilized/exacerbated from baseline to 12 weeks/24 weeks/36 weeks/48 weeks