BACKGROUND: Nintedanib is in clinical development as a treatment for idiopathic 
pulmonary fibrosis (IPF). Data from the Phase II TOMORROW study suggested that 
nintedanib 150 mg twice daily had clinical benefits with an acceptable safety 
profile.
METHODS: The INPULSIS™ trials are replicate Phase III, randomized, double-blind, 
studies comparing the efficacy and safety of nintedanib 150 mg twice daily with 
placebo in patients with IPF. Eligible patients were aged ≥40 years with a 
diagnosis of IPF within 5 years before randomization who had undergone a chest 
high-resolution computed tomography (HRCT) scan within 1-year before screening, 
and who had a forced vital capacity (FVC) of ≥50% predicted and a diffusing 
capacity for carbon monoxide of 30-79% predicted. Participants were randomized 
3:2 to receive nintedanib or placebo for 52 weeks. The primary endpoint is the 
annual rate of decline in FVC. The key secondary endpoints are change from 
baseline in the total score on the St. George's Respiratory Questionnaire (a 
measure of health-related quality of life) over 52 weeks and time to first acute 
exacerbation.
RESULTS: Enrolment of 1066 patients in 24 countries was completed in September 
2012. Results will be reported in the first half of 2014.
CONCLUSION: The INPULSIS™ trials will determine the efficacy of nintedanib in 
patients with IPF, including its impact on disease progression as defined by 
decline in FVC, acute exacerbations and health-related quality of life. In 
addition, they will characterise the adverse event profile of nintedanib in this 
patient population.
TRIAL REGISTRATION: Registered at ClinicalTrials.gov (identifiers: NCT01335464 
and NCT01335477).