The purpose of this study is to determine whether potentiating the cystic fibrosis
transmembrane conductance regulator (CFTR) with QBW251 in patients with bronchiectasis will
demonstrate clinical safety and efficacy related to improved mucociliary clearance with
reduced bacterial colonization as potential drivers of airway obstruction, reduced airway
inflammation, exacerbations and mucus load, improved lung function, clinical symptoms and
quality of life to support further development in bronchiectasis.
This is a randomized, subject- and investigator-blinded, placebo-controlled, parallel-group
study investigating the preliminary efficacy and safety of QBW251 administered orally for 12
weeks in subjects with bronchiectasis. Approximately 72 subjects will be randomized in a 1:1
ratio to receive either QBW251 or placebo in order to achieve 60 subjects who complete the
treatment period based on the assumption of a 16% drop-out rate. The sample size assumptions
will be reviewed in an interim analysis in a blinded manner when approximately 14 subjects
complete the treatment period.
The study consists of the following periods: Screening, baseline/Day 1, treatment period, and
end of study assessments (EOS) visit followed by an additional post-treatment safety follow
up via phone call. The total duration for each patient in the study is up to approximately 18
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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