Diffuse Lung Disease |

Design and Rationale of the Idiopathic Pulmonary Fibrosis: Prospective Outcomes (IPF-PRO) Registry FREE TO VIEW

Emily O'Brien; Michael Durheim; Victoria Gamerman, MA; Sandra Garfinkel, RN; Kevin Anstrom, PhD; Scott Palmer, MHS; Craig Conoscenti
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Duke Clinical Research Institute, Durham, NC

Chest. 2014;146(4_MeetingAbstracts):369A. doi:10.1378/chest.1994307
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SESSION TITLE: Interstitial Lung Disease Posters II

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM

PURPOSE: Idiopathic pulmonary fibrosis (IPF) is a progressive, often fatal interstitial lung disease of unknown etiology. There is a large unmet need for contemporary prospective data in IPF to better understand the natural history of the disease, current practice patterns, and clinical and patient-reported outcomes. Furthermore, while there has been increasing interest in biomarkers and the genetic basis of IPF, additional work is needed to refine these tools to improve clinical practice and predict disease outcomes.

METHODS: IPF-PRO is a national, multicenter, observational registry of patients aged ≥40 years with newly diagnosed IPF. The registry will enroll 300 patients over 2 years at approximately 14 tertiary pulmonary care sites in the United States. Participants will receive usual care for IPF as defined by the treating physician. At baseline, retrospective medical record review will be used to characterize patient interactions with the health care system during the 12-month period prior to IPF diagnosis. Enrolling sites will abstract medical record data on diagnostic evaluations, pulmonary function, physical examinations, laboratory data, and clinical events at 6-month intervals for up to 5 years after enrollment. Patient reported outcomes including quality of life, pulmonary symptom burden and functional status will be collected at baseline and regularly scheduled clinic visits closest to 6-month intervals from enrollment. Blood samples including DNA, RNA, plasma, and serum will be collected throughout the registry.

RESULTS: The IPF-PRO Registry will follow approximately 300 patients for a minimum of 3 years, and up to 5 years.

CONCLUSIONS: IPF-PRO is a novel, multicenter, observational registry that will prospectively collect longitudinal data on IPF patients receiving usual care in the US.

CLINICAL IMPLICATIONS: The IPF-PRO Registry will create an opportunity to expand our understanding of the natural history of IPF, its impact on patients, and current practice patterns and provide a repository of well-phenotyped biological samples for further exploration.

DISCLOSURE: Emily O'Brien: Grant monies (from industry related sources): Institution received an IPF-PRO Registry Grant from Boehringer Ingelheim (Clinicaltrials.gov identifier: NCT01915511) Michael Durheim: Grant monies (from industry related sources): Boehringer Ingelheim – Study sponsor Victoria Gamerman: Employee: Victoria Gamerman is an employee of Boehringer Ingelheim Pharmaceuticals Inc. Sandra Garfinkel: Employee: Sandra Garfinkel is an employee of Boehringer Ingelheim Pharmaceuticals Inc. Kevin Anstrom: Grant monies (from sources other than industry): Money paid to Kevin Anstrom's institution - Name of entity: DCRI, Consultant fee, speaker bureau, advisory committee, etc.: Kevin Anstrom has been paid consultancy fees by Abbott Vascular, AstraZeneca, BMS, Pfizer, GSK, Ikaria Scott Palmer: Grant monies (from industry related sources): Money paid by Boehringer Ingelheim to Scott Palmer's institute (DCRI), Consultant fee, speaker bureau, advisory committee, etc.: Board membership (DSMB) - GSK study, Grant monies (from industry related sources): Grant money paid to Scott Palmer's institution by Biomarker Factory, NHLBI, BMS and Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Scott Palmer received payment for CME lectures, Other: Scott Palmer has been paid royalties Craig Conoscenti: Employee: Craig Conoscenti is an employee of Boehringer Ingelheim Pharmaceuticals Inc.

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