A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministered with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment

  • STATUS
    Recruiting
  • sponsor
    BI
Updated on 23 November 2020

Summary

A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministered with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment

Description

To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in IPF patients with advanced lung function impairment.

If patients qualify, all study procedures including lab work, tests, study visits, and the study drug are provided to you free of charge by the sponsor.

Details
Condition Idiopathic Pulmonary Fibrosis
Clinical Study IdentifierTX145412
SponsorBI
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed (including any required washout)
Male or female patients aged ≥40 years at visit 1
A clinical diagnosis of IPF within the last 6 years before visit 1
Combination of high-resolution computed tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with a diagnosis of IPF as assessed by the investigator based on a HRCT scan performed within 18 months of visit 1
DLCO (corrected for Hb) ≤ 35% predicted of normal at visit 1
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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