RT Journal Article
SR Electronic
T1 Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease
JF BMJ Open Respiratory Research
JO BMJ Open Resp Res
FD British Thoracic Society
SP e000212
DO 10.1136/bmjresp-2017-000212
VO 4
IS 1
A1 Kevin R Flaherty
A1 Kevin K Brown
A1 Athol U Wells
A1 Emmanuelle Clerisme-Beaty
A1 Harold R Collard
A1 Vincent Cottin
A1 Anand Devaraj
A1 Yoshikazu Inoue
A1 Florence Le Maulf
A1 Luca Richeldi
A1 Hendrik Schmidt
A1 Simon Walsh
A1 William Mezzanotte
A1 Rozsa Schlenker-Herceg
YR 2017
UL http://bmjopenrespres.bmj.com/content/4/1/e000212.abstract
AB 600 patients aged ≥18 years will be randomised in a 1:1 ratio to nintedanib or placebo. Patients with diagnosis of IPF will be excluded. The study population will be enriched with two-thirds having a usual interstitial pneumonia-like pattern on HRCT. The primary endpoint is the annual rate of decline in forced vital capacity over 52 weeks. The main secondary endpoints are the absolute change from baseline in King’s Brief Interstitial Lung Disease Questionnaire total score, time to first acute interstitial lung disease exacerbation or death and time to all-cause mortality over 52 weeks.Ethics and dissemination The trial is conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (GCP) and Japanese GCP regulations.Trial registration number NCT02999178.