German pharmaceutical firm Boehringer Ingelheim has begun patient enrolment in the Phase III clinical trial of nintedanib (OFEV) to treat progressive fibrosing interstital lung disease (PF-ILD).
Nintedanib targets growth factor receptors known to be involved in the pulmonary fibrosis mechanisms, and also blocks the signalling pathways associated with fibrotic processes to slow the decline in lung function.
The double-blind, randomised, placebo-controlled Phase III trial will enrol a total of 600 patients with different fibrosing lung diseases.
The trial is designed to evaluate the efficacy and safety of nintedanib 150mg twice daily over 52 weeks in various progressive fibrosing lung conditions other than idiopathic pulmonary fibrosis (IPF).
Boehringer Ingelheim chief medical officer Dr Christopher Corsico said: “Boehringer Ingelheim is dedicated to advancing the understanding of fibrosing lung diseases where no or limited treatments exist.
"Our innovative PF-ILD trial is designed to include patients with fibrosing lung diseases who would not otherwise be eligible to participate in a clinical trial."
The trial will enrol PF-ILD patients with documented lung scarring on imaging and whose lung function and respiratory symptoms or chest imaging have aggravated even after treatment.
The primary endpoint of the trial is the measure of disease progression as an annual rate of decline in forced vital capacity (FVC), while the secondary endpoints include time to first ILD exacerbation and overall survival.
The Phase III trial will also examine other clinical evaluations such as absolute change from baseline in the King's brief interstitial lung disease questionnaire (K-BILD), which measures the health-related quality of life of patients with ILDs to assess the impact of treatment.