Fibrosing interstitial lung disease (ILD) of unknown origin MedDRA version: 19.1 Level: PT Classification code 10022611 Term: Interstitial lung disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912/F01
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PIRFENIDONE
CAS Number: 53179-13-8
Current Sponsor code: RO0220912/F01
Con
Sponsors
Roche Farma S.A, que representa en España a F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18-85 years - Confirmed fibrosing ILD which, following multidisciplinary team review, cannot be classified with either high or moderate confidence as a specific idiopathic interstitial pneumonia or other defined ILD - Progressive disease as considered by the investigator as patient deterioration within the last 6 months, which is defined as a rate of decline in forced vital capacity (FVC) >5% or a significant symptomatic worsening not due to cardiac, pulmonary vascular or other causes - Extent of fibrosis >10% on high-resolution computed tomography within the last 12 months -Forced vital capacity >= 45% of predicted value -Diffusing capacity of the lung for carbon monoxide (DLco) >= 30% of predicted value -Forced expiratory volume in 1 second/FVC ratio >= 0.7 -Able to do 6-minute walk distance (6MWD) >= 150 meters -For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: -Diagnosis with moderate or high confidence of nonspecific interstitial pneumonia and any ILD with an identifiable cause such as connective tissue disease-ILD, chronic hypersensitivity pneumonitis, or others -Diagnosis of idiopathic pulmonary fibrosis independent of the confidence level -History of unstable angina or myocardial infarction during the previous 6 months -Treatment with high dose systemic corticosteroids, or any immunosuppressant other than mycophenolate mofetil/acid (MMF), at any time at least 4 weeks prior to the screening period. Patients being treated with MMF should be on a stable dose that is expected to remain stable throughout the trial and was started at least 3 months prior to screening -Patients previously treated with pirfenidone or nintedanib -Patients treated with N-acetyl-cysteine for fibrotic lung disease, at any time within the 4 weeks of the screening period -Drug treatment for any type of pulmonary hypertension -Participation in a trial of an investigational medicinal product within the last 4 weeks -Significant co-existent emphysema (extent greater than extent of fibrosis on high-resolution computed tomography within the last 12 months) -Significant other organ co-morbidity including hepatic or renal impairment -Predicted life expectancy 1.5 × ULN, and Alkaline phosphatase >2.0 × ULN -Creatinine clearance = 500 milliseconds at screening, or a family or personal history of long QT syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the effect of pirfenidone versus (vs.) placebo on lung function parameters;Secondary Objective: •To evaluate the efficacy of pirfenidone vs. placebo from baseline (Day 1) until Week 24 on other functional parameters, outcomes, and patient-reported outcomes •To evaluate the safety of pirfenidone vs. placebo;Primary end point(s): Rate of decline in FVC measured in mL by daily handheld spirometer over the 24-week double-blind treatment period;Timepoint(s) of evaluation of this end point: Up to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Change in percent predicted FVC and in mL measured by spirometry during clinic visits 2.Categorical change in FVC of > 5% , measured both by daily spirometry as well as by spirometry during clinic visits 3.Categorical change in FVC of > 10%, measured both by daily spirometry as well as by spirometry during clinic visits 4.Change in percent predicted DLco 5.Change in 6MWD in meters 6.Change in University of California, San Diego-Shortness of Breath Questionnaire score 7.Change in score in Leicester Cough Questionnaire 8.Change in cough visual analog scale 9.Change in total and sub-scores of the St. George's Respiratory Questionnaire 10.Number of participants with non-elective hospitalization, both respiratory and all cause 11.Incidence of, and time to first, investigator-reported acute exacerbations 12.Progression-free survival (PFS), defined as the time to the first occurrence of a >10% absolute decline in percent predicted FVC, a >50 m decline of 6MWD, or death 13.PFS, alternatively defined as the time to the first occurrence of a >10% absolute decline in percent predicted FVC, non-elective respiratory hospitalization, or death 14.Time to death from any cause 15.Time to death from respiratory diseases 16.Nature, frequency, severity, and timing of treatment-emergent adverse events 17.Dose reductions and treatment interruptions 18.Abnormalities in clinical laboratory test results 19.Abnormalities in 12-lead ECG 20.Number of participants withdrawn from trial treatment or trial discontinuations;Timepoint(s) of evaluation of this end point: 1-5. Screening (Days -21 to -1) to Week 24 6-9. Week 1 (Day 1) to Week 24 10. Up to Week 91 11-13. Week 1 (Day 1) to Week 24 14-16. Up to Week 91 17. Week 1 to Week 24 18. Screening to Week 24 19. Screening to Week 28 20. Up to Week 91 | — |
Countries
Australia, Belgium, Canada, Czech Republic, Denmark, Germany, Greece, Ireland, Israel, Italy, Poland, Portugal, Spain, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd.
Outcome results
None listed