About this trial
This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF).
Eligibility criteria
Qualifiers
Less than 10 years of age at the first study visit.
Documentation of a CF diagnosis.
Participated in Part A OR less than 7 years of age at the first study visit.
Documentation of a CF diagnosis.
Disqualifiers
Use of an investigational drug within 28 days prior to and including the first study visit.
Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 28 days prior to and including the first study visit.
Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.
Trial design
Treatments tested in this trial
- Ivacaftor or elexacaftor/tezacaftor/ivacaftor
Treatment groups
Sponsors and collaborators
Sonya Heltshe
Lead sponsor
Seattle Children's Hospital
Sponsor institution
Cystic Fibrosis Foundation
Collaborator
University of Washington
Collaborator
University of Alabama at Birmingham
Collaborator