BI 1265162 in adolescents and adults with cystic fibrosis

A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis

This is a randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis. The study drug, (BI 1265162) is an inhaled form of an oral medication that has been used for many years in the treatment of high blood pressure in conjunction with other medications. This is a Multi-centre trial conducted in approximately 10 countries and 98 patients will be randomised including 21 adolescent patients. The treatment period will last 4 weeks and during this time participants will be asked to undergo physical examinations, have blood taken for laboratory tests, undergo Electrocardiograms (ECGs), Pulmonary Function Tests, answer questionnaires about their overall health and CF and complete a diary and undergo a multiple breath washout test.