Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis
Status:
Not yet recruiting
Trial end date:
2025-03-31
Target enrollment:
Participant gender:
Summary
This study will provide important mechanistic information regarding the effect of inhaled
mannitol (Bronchitol) in people with cystic fibrosis (PwCF) with moderate to severe disease
who are already using elexacaftor/tezacaftor/ivacaftor (E/T/I). Many patients have already
discontinued hypertonic saline and other pulmonary therapies because of the profound effect
of E/T/I of their symptoms and lung function. Further, because both inhaled osmotic agents
(i.e., Bronchitol, hypertonic saline [HS]) and E/T/I are believed to exert their beneficial
effects through improvements in mucociliary clearance (MCC), it is unknown if the combination
of these therapies might be additive or are redundant in a population with moderate to severe
disease where bronchiectasis and chronic infection persists, and where eventual decline in
lung function is expected over time. This study, therefore, will be the first to determine
whether "add on" therapy with inhaled mannitol is able to further accelerate MCC in E/T/I
patients. These data would provide some guidance regarding the use of these approved
therapies in PwCF.