Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF) Clinical Trial

Official title:

Prospective, Longitudinal Cohort Trial of Patients With Idiopathic Pulmonary Fibrosis (IPF) and Healthy Control Patients. Clinical Data, Blood, and Bronchiolavage (BAL) Fluid Will be Collected Over 12 Months.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718990
• Other study ID #: PPG-IPF
• Status: Completed
• Start date: October 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Drug discovery can take many years especially since most studies to measure effectiveness depend on clinical outcomes like pulmonary function tests and hospitalizations.

This is an observational study designed to collect information, blood, and bronchoalveolar lavage fluid in people who have IPF and those who do not. The people who have IPF will be followed for 12 months to collect more biological samples and record clinically relevant information.

The goal of this study is to identify new molecular markers that are measurable and reliable in people who have IPF. It is hoped that these markers can be used in future drug studies to significantly speed up the process of finding drugs that help.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 35 to 80 years

• a diagnosis of IPF by consensus criteria

Exclusion Criteria:

• any condition that makes the patient at unacceptable risk for bronchoscopy

• the presence of significant co-existing emphysema on HRCT

• active cigarette smoking (defined as smoking within the last 6 months)

• the presence of a significant co-morbidity felt to limit life expectancy to less than 12 months.

• active listing for lung transplantation

• inability to provide informed consent

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular Markers	We anticipate that we will successfully enroll 60 subjects with IPF in a 12 month longitudinal cohort study and provide biological samples (Bronchiolavage (BAL), alveolar macrophages, and blood) to Projects 1-3 for use in identifying mechanistically-informative markers of alveolar epithelial cell ER stress, avß6-mediated TGFß activation, and EMT. We expect that levels of some of these mechanistic markers will be measurable in patient samples, and may be differentially present in IPF compared to normal controls. Variations in baseline levels of mechanistically-informative molecular markers may identify subgroups of Idiopathic Pulmonary Fibrosis (IPF) patients that share distinct clinical phenotypes.	12 months