idiopathic pulmonary fibrosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with IPF who satisfied the diagnostic criteria of ATS/ERS/JRS/ALAT 2018 [According to past medical history, laboratory tests and HRCT (typical UIP and Probable UIP)]. 2. Aged 40-80 years, both male and female. 3. Patients who never received any NAC or anti-fibrotic agents (including Pirfenidone and Nintedanib) before visiting Shanghai Pulmonary Hospital. 4. Regularly followed-up in Shanghai Pulmonary Hospital for one year during drug administration.
Exclusion criteria
Exclusion criteria: 1. Patients without required medical records according to the protocol. 2. Patients with malignant tumours. 3. Patients with severe diseases of other systems (e.g. patients with severe cardiac, renal or hepatic deficiencies based on judgement of investigators). 4. Concomitant drug not in accordance with the protocol (e.g. Azathioprine, Steine-mucolytic agent). 5. Other conditions inappropriate for enrollment according to the judgement of investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SGRQ at one year; | — |
Secondary
| Measure | Time frame |
|---|---|
| SGRQ at six months;FVC% decline rate compared to baseline (at six months and one year);DLco% decline rate compared to baseline (at six months and one year);Numbers of acute exacerbation within one year;PaO2 and/or SaO2 decline compared to baseline (both absolute value and decline rate, at six months and one year);HRCT change (HRCT score, at six months and one year);6MWD change (absolute value decline, at six months and one year).; | — |
Countries
China
Contacts
Department of Respiratory Medicine, Shanghai Pulmonary Hospital Tongji University, School of Medicine