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OpenTrials
Completed

NCT Number: NCT02151435

Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal, fibrotic disorder of the lung. The estimated prevalence is 30-80/100,000 in the United States with incidence estimates clearly rising. A major challenge in the care of patients with IPF is determining prognosis. The natural history of IPF is usually one of inexorable decline in lung function, ultimately resulting in death from respiratory failure. However, longitudinal physiologic decline in IPF is heterogeneous and difficult to predict in individual patients. While some patients with IPF may remain stable for years, in others the disease may progress rapidly over a relatively short time. We hypothesize that peripheral blood biomarkers based on extracellular matrix and matrix-modifying molecules will improve prognostication in patients with IPF.

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Key information

Conditions

IPF Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 35-80 years, inclusive
  • Diagnosis of IPF by HRCT or surgical lung biopsy
  • Able to understand and provide informed consent

Exclusion criteria

  • AE-IPF during the prior year
  • Environmental exposure (occupational, drug, etc.) felt to be the etiology of the interstitial disease.
  • Diagnosis of collagen-vascular conditions according to published American College of Rheumatology criteria.
  • Significant airway obstruction (FEV1/FVC ratio < 0.60) or bronchodilator response, defined as a change in FEV1 ≥ 12% and absolute change > 200 mL OR change in FVC ≥ 12% and absolute change > 200 mL at baseline
  • Partial pressure of arterial oxygen (PaO2) < 55 mm Hg
  • Evidence of active infection
  • Listed for lung transplantation
  • Myocardial infarction, coronary artery bypass, or angioplasty within 6 months
  • Unstable angina pectoris or congestive heart failure requiring hospitalization or deteriorating within 6 months
  • Uncontrolled arrhythmia or hypertension
  • Known HIV, hepatitis C, cirrhosis, or chronic active hepatitis
  • Active substance and/or alcohol abuse
  • If you are pregnant or breastfeeding
  • Any condition other than IPF that is likely to result in your death within the next year
  • Any condition that, in the judgment of the PI, might cause participation in the study to be detrimental to you or that the PI deems makes you a poor candidate

Treatment and study plan

Primary outcomes

  1. Progression-free survival

    Time frame: 1 year

    The primary outcome is your progression free survival as determined by time until any of: death, acute exacerbation of IPF, relative decline in FVC (liters) of at least 10% or DLCO (ml/min/mmHg) of 15% from baseline.

Other outcomes

  1. Longitudinal change in biomarker levels

    Time frame: 1 year

    In exploratory analyses, longitudinal change in your biomarker expression will be correlated with your disease progression to determine if change in biomarker levels over time predict subsequent disease progression.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Brown University
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 30, 2014
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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