Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment

Phase 4

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: placebo; Drug: nintedanib

• Registration Number: NCT02788474
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Identifying biomarkers to predict the clinical course and benefits of therapy early in the course of the disease remains one of the most urgent and relevant challenges to improve overall patient management, to prevent treatment delay or overtreatment. This study is conducted to examine the effect of nintedanib treatment on change in biomarkers indicative of extracellular matrix turnover which have been shown recently to correlate with disease progression. This study further aims to confirm the association of biomarker course during the first three months of treatment and disease progression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-05-27
• Study First Posted: 2016-06-02
• Study Start: 2016-06-09
• Primary Completion: 2017-08-04
• Disposition First Submitted: 2018-05-17
• Disposition First Submitted QC: 2018-05-17
• Disposition First Posted: 2018-05-18
• Study Completion: 2018-06-08
• Results First Submitted: 2019-05-29
• Results First Submitted QC: 2019-07-16
• Results First Posted: 2019-08-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
nintedanib	nintedanib	-

Primary Outcome Measures

Name	Time	Method
The Rate of Change (Slope) in Blood C-reactive Protein Degraded by Matrix Metalloproteinase-1/8 (CRPM) From Baseline to Week 12.	baseline and 12 weeks	The rate of change (slope) in blood C-reactive protein degraded by matrix metalloproteinase-1/8 (CRPM) from baseline to week 12 is presented. The mean presented is the adjusted rate based on a random coefficient regression (CRPM log 10 transformed) with fixed effects for gender, age, height and random effect of patient specific intercept and time.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Disease Progression as Defined by Absolute Forced Vital Capacity (FVC) Decline >=10% or Death Until Week 52	52 weeks	For this endpoint, disease progression was defined by absolute FVC (percentage of predicted) decline ≥10% or death up to Week 52 based on in-clinic supervised spirometry.; This is a key secondary endpoint of the trial. This outcome measure is "percentage of patients with disease progression" and CRPM is included in the various models as a factor/covariate, and that this outcome measure, the percentage of progressors are displayed under "Measured values"
The Rate of Change in Blood Collagen 1 Degraded by Matrix Metalloproteinase-2/9/13 (C1M) From Baseline to Week 12	baseline and 12 weeks	The rate of change in blood Collagen 1 degraded by matrix metalloproteinase-2/9/13 (C1M) from baseline to week 12 is presented.; The mean presented is the adjusted rate based on a random coefficient regression (C1M (negative reciprocal root transformation)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.
The Rate of Change in Blood Collagen 3 Degraded by Matrix Metalloproteinase-9 (C3M) From Baseline to Week 12	baseline and 12 weeks	The rate of change in blood Collagen 3 degraded by matrix metalloproteinase-9 (C3M) from baseline to week 12 is presented.; The mean presented is the adjusted rate based on a random coefficient regression (C3M- log 10 transformation) with fixed effects for gender, age, height and random effect of patient specific intercept and time.

Trial Locations

Locations (86)

Jasper Summit Research, LLC; 🇺🇸 Jasper, Alabama, United States

Western Connecticut Medical Group; 🇺🇸 Danbury, Connecticut, United States

St. Francis Medical Institute; 🇺🇸 Clearwater, Florida, United States

University of Florida College of Medicine; 🇺🇸 Jacksonville, Florida, United States

Minnesota Lung Center; 🇺🇸 Minneapolis, Minnesota, United States

The Lung Research Center, LLC; 🇺🇸 Chesterfield, Missouri, United States

Clinical Research Solutions; 🇺🇸 Dayton, Ohio, United States

Pulmonary Associates of Richmond, Inc.; 🇺🇸 Richmond, Virginia, United States

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, Sydney, New South Wales, Australia

Concord General Repatriation Hospital -Ambulatory Care Unit; 🇦🇺 Concord, New South Wales, Australia

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