Journal article
Design of the INPULSIS™ trials: Two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis
Abstract
BACKGROUND: Nintedanib is in clinical development as a treatment for idiopathic pulmonary fibrosis (IPF). Data from the Phase II TOMORROW study suggested that nintedanib 150 mg twice daily had clinical benefits with an acceptable safety profile.
METHODS: The INPULSIS™ trials are replicate Phase III, randomized, double-blind, studies comparing the efficacy and safety of nintedanib 150 mg twice daily with placebo in patients with IPF. Eligible …
Authors
Richeldi L; Cottin V; Flaherty KR; Kolb M; Inoue Y; Raghu G; Taniguchi H; Hansell DM; Nicholson AG; Le Maulf F
Journal
Respiratory Medicine, Vol. 108, No. 7, pp. 1023–1030
Publisher
Elsevier
Publication Date
July 2014
DOI
10.1016/j.rmed.2014.04.011
ISSN
0954-6111
Associated Experts
Fields of Research (FoR)
Sustainable Development Goals (SDG)
Medical Subject Headings (MeSH)
Clinical Trials, Phase III as TopicDisease ProgressionDouble-Blind MethodDrug Administration ScheduleHumansIdiopathic Pulmonary FibrosisIndolesMulticenter Studies as TopicPatient SelectionProtein Kinase InhibitorsQuality of LifeRandomized Controlled Trials as TopicResearch DesignTomography, X-Ray ComputedTreatment OutcomeVital Capacity