Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01718990

Enrollment

110

Registered

2012-11-01

Start date

2012-10-31

Completion date

2018-12-31

Last updated

2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Molecular Markers	12 months	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, αvβ6-mediated TGFβ 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.

Countries

United States

Outcome results