Clinical Trials Logo
  1. Home
  2. Lung Diseases, Interstitial
  3. NCT03099187

A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease

Lung Diseases, Interstitial Clinical Trial

Official title:
Multicenter, International, Double-blind, Two-Arm, Randomized, Placebo-controlled Phase II Trial of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing ILD

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of pirfenidone in participants with fibrosing interstitial lung disease (ILD) who cannot be classified with moderate or high confidence into any other category of fibrosing ILD by multidisciplinary team (MDT) review ("unclassifiable" ILD).

Clinical Trial Description

Study participants will be randomised to receive 801 mg pirfenidone or placebo three times daily for 24 weeks. The efficacy of pirfenidone versus placebo will be assessed by daily measurement of forced vital capacity using a handheld spirometer over the treatment period. Additionally, the study will assess the efficacy and safety of pirfenidone with and without concomitant mycophenolate mofetil treatment and in study participants with or without interstitial pneumonia with autoimmune features (IPAF). All study participants who attend the follow-up visit at Week 28 will be offered the opportunity to receive open-label pirfenidone within the trial protocol. In order to maintain blinding of the controlled period of the study, all study participants will discontinue treatment by Week 24 and return for a follow-up visit 4 weeks later. Study participants eligible to participate in the single-arm 12-month extension will be initiated on open-label pirfenidone during this visit (re-starting the dose titration from one capsule three times daily [TID]). During the long-term extension period, study participants will be monitored for safety, initially at monthly visits during the first 6 months and thereafter approximately every 3 months. A final follow-up visit will take place 4 weeks after the last dose of pirfenidone is taken. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03099187
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 2
Start date May 15, 2017
Completion date January 10, 2020
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04119115 - Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases
Active, not recruiting NCT04559581 - Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Recruiting NCT05151640 - INCHANGE - Nintedanib for Changes in Cough and Dyspnea in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Completed NCT02251964 - Rituximab in Interstitial Pneumonitis Phase 2/Phase 3
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Completed NCT01442779 - Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT05596760 - Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers N/A
Recruiting NCT05866198 - Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation N/A
Active, not recruiting NCT05321082 - A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) Phase 3
Completed NCT04016168 - Idiopathic Pulmonary Fibrosis and Serum Bank
Recruiting NCT00258583 - Dorothy P. and Richard P. Simmons Center for ILD Research Registry
Recruiting NCT05855109 - Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
Completed NCT05719233 - Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease
Recruiting NCT04159129 - Effects of Pulmonary Rehabilitation on Walking Speed in Patients With COPD or ILD Patients
Completed NCT03313180 - A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis Phase 3
Completed NCT05065190 - A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis Phase 3
Completed NCT03136120 - Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease
Recruiting NCT04930666 - BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease
Recruiting NCT05503030 - Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients