A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.

Not Applicable

• Conditions: Idiopathic pulmonary fibrosis

• Registration Number: JPRN-UMIN000015508
• Lead Sponsor: Grant for Research on Diffuse Lung Disease from the Ministry of Health, Labour and Welfare of Japan.

Brief Summary

There was no difference between the two groups in the of change in FVC.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-24
• Study Completion: 2018-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

1.coexisting severe cardiovascular disease 2.coexisting severe liver disfunction 3.coexisting chronic kidney disease 4.patients who had a history of receiving chemotherapy or thoracic radiotherapy 5.patients who are pregnant or possibly pregnant, or nursing 6.patients who were unable to undergo physiologic tests 7.candidates for lung transplantation 8.improving physiologic tests or HRCT findings compared with previous 6 months. 9.patient who were administered with 20 mg/day or more of predonisolone during the preceding 3 months. Treated with NAC or nintedanib during the preceding 3 months. 10.treated with immunosuppressive agents. 11.coexisting pulmonary arterial hypertension, bronchial asthma,sarcoidosis,bronchiectasis, neoplasm,infectious disease. 12.patients who participated in another clinical study within 3 months prior to the administration period of the study drug. 13.considered ineligible for the study by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in forced vital capacity

Secondary Outcome Measures

Name	Time	Method
(1)Changes in distance and lowest SpO2 in 6-minute walk test, (2)Changes in vital capacity(VC), %VC, total lung capacity(TLC), %TLC, diffusion capacity of the lung for carbon monoxide (DLco), %DLco. A category analysis of FVC (5% or greater decline or decline less than 5% in FVC) (3) Changes in serum maker (KL-6, SP-D, SP-A) (4) Changes in high-resolution computed tomography (HRCT) findings (5) Changes in dyspnea (mMRC) (6) Changes in health Health-related Quality of Life (CAT score) (7) Safety (8) Incidence of acute exacerbation (9) Progression-free survival time (10) Survival