The purpose of this protocol is to test the safety, pharmacokinetics, and pharmacodynamics of
the Cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, ivacaftor in
patients with chronic obstructive pulmonary disease (COPD) and chronic bronchitis. This
project will investigate the hypothesis that ivacaftor can augment CFTR activity in
individuals with COPD who exhibit chronic bronchitis, resulting in meaningful improvements in
epithelial function and respiratory health. The study is a multicenter, randomized,
double-blind, placebo-controlled, stratified study of orally-administered ivacaftor.
Phase:
Phase 2
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Vertex Pharmaceuticals Incorporated