Germany's Boehringer Ingelheim has started a new trial to evaluate the safety, tolerability and pharmacokinetics (PK) of OFEV (nintedanib) with add-on treatment pirfenidone.
The treatment method is for patients with idiopathic pulmonary fibrosis (IPF), a rare condition that causes thickening and scarring of the lung tissue over time. This limits the amount of oxygen that can be delivered to major organs, and also causes breathing difficulties.
The trial's primary endpoint is the percentage of patients with on-treatment gastrointestinal (GI) adverse events from baseline to week 12, as the most frequent adverse events for both products are of a gastrointestinal nature.
The company noted that on-treatment adverse events are defined as AEs, with an onset from the first dose of randomised treatment up to the last dose of randomised treatment.
100 IPF patients will be enrolled in the 12-week trial from 25 study centres in the US, Canada, Italy, Germany, France, and the Netherlands.
The trial's secondary endpoint, the amount of OFEV and pirfenidone circulating in the blood, will be measured to evaluate whether pirfenidone influences the amount of OFEV found in the blood.
Boehringer Ingelheim Medicine corporate senior vice-president and chief medical officer Dr Christopher Corsico said: "The safety and wellbeing of patients is at the centre of everything we do. We are initiating this trial to ensure that we provide the scientific community with important information regarding OFEV combination therapy.
"This trial is part of our continued commitment to tackling the global burden of progressive fibrotic lung diseases."
The median survival of IPF patients following diagnosis is just two to three years, underlining the importance of early and accurate diagnosis, and treatments that can help to slow disease progression.
Italy Regional Centre for Rare Lung Diseases profesor Carlo Vancheri said: "With the publication in July 2015 of the updated international evidence-based guideline for IPF, we now have conditional recommendations for the use of two approved treatment options for patients with IPF; nintedanib and pirfenidone.
"However, there has been limited evidence to date to establish the safety of combining these treatments. This new trial will provide essential information regarding the safety of adding pirfenidone to core treatment with nintedanib, and could help guide future therapy decisions in IPF."