Efficacy of Pirfenidone versus placebo in Idiopathic Pulmonary Fibrosis progression:a randomize clinical trial

Efficacy of Pirfenidone versus placebo in Idiopathic Pulmonary Fibrosis progression: a randomize clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017031333044N1

Enrollment

Registered

2017-07-13

Start date

2014-03-20

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis. Interstitial pulmonary disease, unspecified

Interventions

Intervention 1: Intervention group No.1: pirfenidone (PIRFENEX 200 mg manufactured by Cipla Ltd) will be added to their previous medication. The final dosage of pirfenidone is 1200 mg daily. At fir

Treatment - Drugs

Placebo

Intervention group No.1: pirfenidone (PIRFENEX 200 mg manufactured by Cipla Ltd) will be added to their previous medication. The final dosage of pirfenidone is 1200 mg daily. At first, the drug w

Intervention group No.2: Placebo will be added to previous medication of these patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1-Confirmed Idiopathic Pulmonary Fibrosis with lung biopsy 2-UIP view in lung HRCT with unknown cause base of ATS-ERS criteria 3-Agreement to participate in this study Exclusion criteria: 1-Suffering from connective tissue disease 2-occupational exposure to substances that cause lung fibrosis 3-close contact with animals 4-Deny to participate in this study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Total Lung Capacity. Timepoint: Before the intervention, three months after the intervention and six months after intervention. Method of measurement: Body box.	—

Secondary

Measure	Time frame
Functional Lung Capacity. Timepoint: Before the intervention, three months after the intervention and six months after intervention. Method of measurement: Body box.;SPO2. Timepoint: Before the intervention, three months after the intervention and six months after intervention. Method of measurement: Body box.;DLCO. Timepoint: Before the intervention, three months after the intervention and six months after intervention. Method of measurement: Body box.	—

Measure

Time frame

Functional Lung Capacity. Timepoint: Before the intervention, three months after the intervention and six months after intervention. Method of measurement: Body box.;SPO2. Timepoint: Before the intervention, three months after the intervention and six months after intervention. Method of measurement: Body box.;DLCO. Timepoint: Before the intervention, three months after the intervention and six months after intervention. Method of measurement: Body box.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactYosef Gholampour

Respiratory Diseases Institute, Masih Daneshvar hospital, Shahid Beheshti University of medical scie

pr.nritld@sbmu.ac.ir+98 21 2610 5050

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026