A Phase IIa Open Label Study To Evaluate The Safety, Tolerability And Efficacy Of S-1226 Administered By Nebulization In Subjects With Mild To Moderate Cystic Fibrosis

Summary

The investigational drug S-1226 is being developed as a possible treatment to aid airway mucous clearance in Cystic Fibrosis. An “investigational” drug is a drug that is being tested and is not approved for sale by Health Canada; it has been approved by Health Canada for this study based on safety data from an earlier trial performed in healthy adult volunteers as well as those with allergic asthma. SolAeroMed Inc. will be supplying the study drug. S-1226 is made of the gas carbon dioxide (CO2) and a liquid called perflubron. Carbon dioxide and perflubron are mixed together to make a mist that is inhaled (breathed in) from a nebulizer using a facemask that covers your nose and mouth. S-1226 has properties that open and lubricate the airways in order to clear the mucus out of the lungs. The study will evaluate the safety, tolerability and efficacy of S-1226 in subjects who have Cystic Fibrosis. The goal of this study is to determine whether daily courses of S-1226 can improve mucous clearance as well as relieve the airway constriction in patients with Cystic Fibrosis.