Abstract
Background: The two replicate, randomised, placebo-controlled, 52-week INPULSIS® trials assessed the efficacy and safety of nintedanib 150 mg bid in patients with IPF. Patients with FVC ≥50% predicted were included. The primary endpoint, the annual rate of FVC decline, was significantly reduced in the nintedanib group compared with placebo in both trials, consistent with slowing of disease progression. Key secondary endpoints were time to first acute exacerbation and change from baseline in SGRQ total score, both over 52 weeks.
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