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news.Boehringer Ingelheim Pharmaceuticals has completed clinical trial enrolment of two Phase III studies evaluating the safety and efficacy of nintedanib (BIBF 1120).
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The two identical 52-week, double-blind, randomised, placebo-controlled trials with matching twice-daily 150mg dosing, inclusion criteria and endpoints enrolled a total of 970 patients in 20 countries.
The annual rate of decline in forced vital capacity (FVC), or the volume of air that is expelled into a spirometer following maximum inhalation is the primary endpoint. Reductions in FVC are reflected in impaired ventilation capacity of the lungs.
The secondary endpoints include health-related quality of life, exacerbations, respiratory mortality, overall survival and on-treatment survival.
University of Michigan Health System Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, associate professor and a study investigator Dr. Kevin Flaherty said the standard of IPF care is limited to oxygen therapy and lung transplant for some patients.
"IPF patients desperately need safe and effective treatments to not only reduce the decline in lung function and eventually decrease mortality, but also to stabilize health-related quality of life and delay or reduce sudden worsening of symptoms, or acute exacerbations," Dr. Flaherty added.
Nintedanib is an investigational compound, in patients with idiopathic pulmonary fibrosis (IPF), being studied at a twice-daily oral dose.