Idiopathic pulmonary fibrosis. Idiopathic pulmonary fibrosis
Conditions
Interventions
Intervention group: participants in the intervention group will receive inhaled pirfenidone at a dose of 100 mg, administered twice daily (morning and evening) for a duration of 6 months. The medicati
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
25 Years to 80 Years
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) based on ATS/ERS/JRS/ALAT clinical and radiological criteria History of oral pirfenidone use for at least 3 months prior to enrollment Forced Vital Capacity (FVC) between 40% and 80% of the predicted value on pulmonary function test Resting oxygen saturation = 88% on room air (without supplemental oxygen)
Exclusion criteria
Exclusion criteria: Diagnosis of any interstitial lung disease (ILD) other than IPF Current smoking or smoking within the past 6 months History of hypersensitivity or intolerance to pirfenidone Presence of severe cardiac, hepatic, or renal disorders that may interfere with study outcomes Pregnancy or breastfeeding Severe psychiatric disorders that may impair the ability to follow study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the percentage of Forced Vital Capacity. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: standard spirometry at rest.;Change in forced expiratory volume in one second. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: standard spirometry.;Change in lung fibrosis severity based on quantitative and qualitative CT scan scoring. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: Qualitative assessment by pulmonologist and quantitative scoring based on a standardized system.;Severity of patient’s cough during the study period. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: Scored using a questionnaire.;Severity of dyspnea measured by the Borg Scale. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: Patient-reported dyspnea severity on the Borg numerical scale.;Change in the distance walked during the 6-minute walk test. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: Performed according to ATS standard protocol.;Change in resting oxygen saturation level. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: Measured by pulse oximetry at rest.;Reduction in TGF-ß levels. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: Measured by ELISA assay in blood samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in forced expiratory volume in one second. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: standard spirometry.;Change in lung fibrosis severity based on CT scan. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: Qualitative assessment by pulmonologist and quantitative scoring based on a standardized system.;Change in severity of cough. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: cough questionnaire.;Change in severity of dyspnea. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: Patient-reported dyspnea severity on the Borg numerical scale.;Levels of liver enzymes. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: Blood tests performed in a standard laboratory.;Kidney tests. Timepoint: Baseline (day 0), 3 months, and 6 months after treatment start. Method of measurement: Blood tests performed in a standard laboratory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAtefeh Abedini
Shahid Beheshti University of Medical Sciences
Outcome results
None listed