Disease History. A. Diagnosis of CF.
B. Forced expiratory volume in 1 second (FEV1) ≥ 70 % predicted at the Screening Visit if < 18 years old, and ≥ 60 % predicted at Screening Visit if ≥ 18 years old. ▪ After interim analysis, if DMC approves, a separate cohort (lower lung function cohort) of approximately 120 subjects ≥ 18 years old with FEV1 40 to < 60 % predicted will be enrolled into Study A.
C. Clinically stable with no significant changes in health status within the 7 days prior to and including the Screening Visit.
D. No active smoking or vaping.
E. Has no other conditions that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Disease History. A. No absolute decrease in FEV1 % predicted of ≥ 10% between the Screening Visit and Visit 1.
B. Clinically stable with no significant changes in health status between the Screening Visit and Visit 1.
Disease History. The disease history will include collection of COVID-19 symptom onset date as well as date and time of admission to hospital and reason for admission (COVID-diagnosis/COVID associated complication or Concomitant Illness).
