Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis

IPF Clinical Trial

Official title:

Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151435
• Other study ID #: UM HUM00004076
• Secondary ID: R01HL109118
• Status: Completed
• Phase: N/A
• First received: May 28, 2014
• Last updated: July 25, 2017
• Start date: August 2013
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 35-80 years, inclusive

2. Diagnosis of IPF by HRCT or surgical lung biopsy

3. Able to understand and provide informed consent

Exclusion Criteria:

1. AE-IPF during the prior year

2. Environmental exposure (occupational, drug, etc.) felt to be the etiology of the interstitial disease.

3. Diagnosis of collagen-vascular conditions according to published American College of Rheumatology criteria.

4. 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

5. Partial pressure of arterial oxygen (PaO2) < 55 mm Hg

6. Evidence of active infection

7. Listed for lung transplantation

8. Myocardial infarction, coronary artery bypass, or angioplasty within 6 months

9. Unstable angina pectoris or congestive heart failure requiring hospitalization or deteriorating within 6 months

10. Uncontrolled arrhythmia or hypertension

11. Known HIV, hepatitis C, cirrhosis, or chronic active hepatitis

12. Active substance and/or alcohol abuse

13. If you are pregnant or breastfeeding

14. Any condition other than IPF that is likely to result in your death within the next year

15. 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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• IPF
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Brown University, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Longitudinal change in biomarker levels	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.	1 year
Primary	Progression-free survival	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.	1 year