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

Idiopathic Pulmonary Fibrosis Clinical Trial

— IPF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136992
• Other study ID #: SPH01312
• Status: Completed
• Phase: Phase 2
• First received: May 11, 2014
• Last updated: May 12, 2014
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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 ?-?), 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China	Nanjing Chia-tai Tianqing Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in forced vital capacity (FVC)	to evaluate changes in FVC from baseline to 12 weeks /24 weeks/36 weeks/48 weeks	48 weeks	No
Secondary	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	No
Secondary	Changes in 6 minute walk distance (6MWD)	Changes in 6 minute walk distance (6MWD) and from baseline to 12/24/36/48weeks	48 weeks	No
Secondary	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	No
Secondary	Dyspnea score according by Modified Medical Research Center(MMRC)	to measure rating dyspnea according by Medi Medical Research Center(MMRC)	48 weeks	No