TIPAL: The effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole, a randomised placebo-controlled multi-centre clinical trial
Chief Investigator: Professor Andrew Wilson
Funder: National Institute for Health Research (NIHR)
Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Health Condition or Problem Studied: Idiopathic Pulmonary Fibrosis (IPF)
Intervention: Patients will be randomised on a 1:1 basis to receive either:
• ACTIVE ARM: Oral lansoprazole 30 mg (as 2 x 15mg capsules) twice daily, 12 hours apart, for 12 months
• CONTROL ARM: Matched placebo (2 capsules) twice daily, 12 hours apart, for 12 months
Trial drug is to be taken at least 30 minutes before food. Dose may be reduced to one capsule twice daily in those developing adverse reactions.
Study Design: This study is an interventional clinical trial of an investigational medicinal product: a phase III, randomised, placebo-controlled, two arm parallel group, double-blind, multicentre clinical trial. Randomisation will be generated by a secure web-based system on a 1:1 basis with minimisation for recruiting site, baseline IPF treatment, reflux and cough sub-study status.
Target Sample Size: 298 participants (149 per group); 160 (80 per group) of whom will be recruited into the cough count sub-study.
Trial Manager - Megan Jones, Megan.L.Jones@uea.ac.uk
Trial Assistant - Thomas Conway, Thomas.Conway@uea.ac.uk
Study email for general enquiries - email@example.com