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Center for Global Research Data

A systematic review and individual patient data meta-analysis of physiological biomarkers in idiopathic pulmonary fibrosis

Lead Investigator: Gisli Jenkins, University of Nottingham
Title of Proposal Research: A systematic review and individual patient data meta-analysis of physiological biomarkers in idiopathic pulmonary fibrosis
Vivli Data Request: 5207
Funding Source: PI is funded by NIHR grant
Conflicts of Interest: RGJ reports grants from GlaxoSmithKline, UK Medical Research Council, Biogen, Galecto, MedImmune; as well as personal fees from Boehringer Ingelheim, Galapagos, GlaxoSmithKline, Heptares, MedImmune, Roche and Pulmatrix; served as consultant for NuMedii and Pliant; a trustee for charities Action for Pulmonary Fibrosis and the British Thoracic Society
None of these will impact data analysis and publication.

Summary of the Proposed Research:

Idiopathic pulmonary fibrosis (IPF) is a devastating condition which causes scarring of the lungs and affects around 3 million people worldwide. Disease trajectory is variable, with some patients progressing much quicker than others. Identifying early predictors of progression may enable relevant therapies to be offered at an early stage. Physiological biomarkers such as lung function (FVC, DLCO) and total distance walked in 6 minutes (6MWD) are non-invasive measurements. We therefore hope to collate data from clinical trial placebo arms to explore whether short term change in these measurements may be able to predict clinical outcomes. This will help better inform healthcare professionals.

Requested Studies:

A 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out
Sponsor: Boehringer Ingelheim
Study ID: NCT00514683
Sponsor ID: 1199.30

A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor: Boehringer Ingelheim
Study ID: NCT01335477
Sponsor ID: 1199.34

A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor: Boehringer Ingelheim
Study ID: NCT01335464
Sponsor ID: 1199.32

A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Sponsor: Roche
Study ID: NCT00287716
Sponsor ID: PIPF-004

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Sponsor: Roche
Study ID: NCT00287729
Sponsor ID: PIPF-006

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)
Sponsor: Roche
Study ID: NCT01366209
Sponsor ID: PIPF-016