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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pirfenidone
placebo
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo (without active ingredient)

    Pirfenidone（200mg）

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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
    Changes in 6 minute walk distance (6MWD)
    Changes in 6 minute walk distance (6MWD) and from baseline to 12/24/36/48weeks
    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.
    Dyspnea score according by Modified Medical Research Center(MMRC)
    to measure rating dyspnea according by Medi Medical Research Center(MMRC)

    Full Information

    First Posted
    May 11, 2014
    Last Updated
    May 12, 2014
    Sponsor
    Shanghai Pulmonary Hospital, Shanghai, China
    Collaborators
    Nanjing Chia-tai Tianqing Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02136992
    Brief Title
    Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
    Acronym
    IPF
    Official Title
    A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Pulmonary Hospital, Shanghai, China
    Collaborators
    Nanjing Chia-tai Tianqing Pharmaceutical

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Pulmonary Fibrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo (without active ingredient)
    Arm Type
    Placebo Comparator
    Arm Description
    placebo will be taken two tablets 3 times a day during the whole study process.
    Arm Title
    Pirfenidone（200mg）
    Arm Type
    Experimental
    Arm Description
    Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.
    Intervention Type
    Drug
    Intervention Name(s)
    Pirfenidone
    Intervention Description
    Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo will be taken two tablets 3 times a day during the whole study process
    Primary Outcome Measure Information:
    Title
    Changes in forced vital capacity (FVC)
    Description
    to evaluate changes in FVC from baseline to 12 weeks /24 weeks/36 weeks/48 weeks
    Time Frame
    48 weeks
    Secondary Outcome Measure Information:
    Title
    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) )
    Description
    Lung function will be measured as improved/stabilized/exacerbated from baseline to 12 weeks/24 weeks/36 weeks/48 weeks
    Time Frame
    48week
    Title
    Changes in 6 minute walk distance (6MWD)
    Description
    Changes in 6 minute walk distance (6MWD) and from baseline to 12/24/36/48weeks
    Time Frame
    48 weeks
    Title
    Life quality: assessed by St. George respiratory questionnaire (SGRQ).
    Description
    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.
    Time Frame
    48 weeks
    Title
    Dyspnea score according by Modified Medical Research Center(MMRC)
    Description
    to measure rating dyspnea according by Medi Medical Research Center(MMRC)
    Time Frame
    48 weeks

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Huiping Li
    Organizational Affiliation
    Shanghai Pulmonary Hospital , Tongji University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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