Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis (IPF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Idiopathic Pulmonary Fibrosis (IPF)

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

No interventions assigned to this group

Healthy Volunteers

Sixty normal controls will be recruited from volunteers.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes