Boehringer Ingelheim and the Duke Clinical Research Institute — which partnered to develop a study aimed at better understanding the health characteristics of people with idiopathic pulmonary fibrosis (IPF) disease at the time of diagnosis and so improve treatment — announced initial results for the first 49 patients in the Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry.
The study, which was initiated in May 2014 and is expected to end in May 2016, reports on the diagnostic methodology used to identify IPF patients, manage symptoms and make sound treatment decisions. Patient reports of clinical outcomes are also registered and blood samples are collected from patients periodically for future research use. Lead author of the study Michael Durheim, MD, Medical Instructor, Department of Medicine, Duke Clinical Research Institute, emphasized the study’s long-term objectives, saying,” We are very excited to share this first look at real-world patients with IPF across 18 IPF academic centers in the United States. As this alliance continues, our objective is to advance the understanding of this devastating disease, through additional findings about diagnosis, treatment patterns and whether blood or genetic markers may impact patient outcomes.”
The first registry results reveal that many patients already have pulmonary impairment when first diagnosed with IPF, as many exhibited symptoms more than a year before the diagnosis. This impairment was evaluated through lung function measures such as forced vital capacity (FVC), which represents the amount of air exhaled after maximum inhalation, at a median of 72%, and diffusing capacity of carbon monoxide (DLCO), which measures the extent to which oxygen reaches the red blood cells, at 39%. Of the 49 patients, 29% required oxygenation while resting and 45% needed supplemental oxygen in physical activities. IPF diagnosis was mainly (48 patients) by high resolution CT scan, while 10 of the patients also underwent surgical biopsy of lung tissue. Other diseases were identified in the IPF patients as well, namely gastroesophageal reflux disease (GERD) in 69% of the patients, and coronary artery disease and sleep apnea, with incidence rates of 29% and 31%, respectively.
The results are being presented at the American College of Chest Physicians Annual Meeting (CHEST 2015), currently underway in Montreal. Danny McBryan, MD, and vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, said of the findings, “These results showed us that many patients already have significant respiratory impairment by the time they are diagnosed by a pulmonologist, which reinforces what we know from ongoing research. The Registry emphasizes the critical need to recognize IPF earlier and send patients to a specialist faster to determine diagnosis and care.”