The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis

Not Applicable

• Conditions: Idiopathic pulmonary fibrosis

• Registration Number: JPRN-UMIN000020682
• Lead Sponsor: ational Hospital Organization Ibarakihigashi National Hospital The center of Chest Diseases and Severe Motor&Intellectual Disabilities

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-22
• Study Completion: 2023-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

the patients with coexisting lung cancer, acute exacerbation of idiopathic pulmonary fibrosis, severe cardiac or hepatic diseases, pulmonary arterial hypertension, sarcoidosis and respiratory infection, the patients who cannot perform pulmonary function test, pregnant women, use of prednisone greater than 20mg/day and immunosuppressives during the preceding 3 months, the patients who participated in other clinical trials in the last 3 months, the patients who are judged inappropriate for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change in vital capacity from baseline to months 12

Secondary Outcome Measures

Name	Time	Method
dyspnea, KL-6, SP-D, %DLCO, changes in the lowest peripheral oxygen saturation during the 6-minute walk test, arterial blood gas, the reduction of ground-glass and reticular opacities, echocardiogram, bronchoalveolar lavage, first occurence of acute exacerbation, the development of lung cancer, survival at 12 months