The effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole: Study protocol for a randomised placebo-controlled clinical trial

This paper describes the design of a randomized, multicenter, double-blind study that will examine changes in lung function, cough, and patient-reported outcomes in 298 patients with IPF treated with lansoprazole versus placebo for 12 months. The primary endpoint will be change in FVC from the first to the last week of the study. Included patients with a pre-existing diagnosis of persistent cough will have the option to participate in a cough substudy, which will assess 24-hour cough frequency (measured using the Vitalograph VitaloJAK cough monitor), cough intensity (assessed using a VAS), and cough-related QoL.