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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Pirfenidone(200mg)tablets will be taken two tablets 3 times a day during the whole study process.
placebo will be taken two tablets 3 times a day during the whole study process
Changes in forced vital capacity (FVC)
to evaluate changes in FVC from baseline to 12 weeks /24 weeks/36 weeks/48 weeks
Time frame: 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
Time frame: 48week
Changes in 6 minute walk distance (6MWD)
Changes in 6 minute walk distance (6MWD) and from baseline to 12/24/36/48weeks
Time frame: 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.
Time frame: 48 weeks
Dyspnea score according by Modified Medical Research Center(MMRC)
to measure rating dyspnea according by Medi Medical Research Center(MMRC)
Time frame: 48 weeks
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