Study design (if review, criteria of inclusion for studies)
Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Participants
Cystic Fibrosis - 6 Years and older (Child, Adult, Older Adult)
Interventions
Drug: ELX/TEZ/IVA|Drug: IVA|Other: Placebo (matched to ELX/TEZ/IVA)|Other: Placebo (matched to IVA)
Outcome measures
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)|Absolute Change in Sweat Chloride (SwCl)|Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain (RD) Score|Absolute Change in Body Mass Index (BMI)|Absolute Change in Weight|Number of Pulmonary Exacerbations (PEx)|Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)