Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis

University of California San Francisco (UCSF)

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Study type: Observational

Funder types: Other

Identifiers

NCT01718990

PPG-IPF

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

Patients with Idiopathic Pulmonary Fibrosis (IPF)

Description:

Sixty patients with IPF will be included in this prospective cohort;15 IPF patients per year for years 1-4.

Healthy Volunteers

Description:

Sixty normal controls will be recruited from volunteers.