Evaluating the Impact of Stopping Chronic Therapies after Modulator Drug Therapy in Cystic Fibrosis: The SIMPLIFY Clinical Trial Study Design

Author:

Mayer-Hamblett Nicole123ORCID,Nichols David P.12ORCID,Odem-Davis Katherine1,Riekert Kristin A.4,Sawicki Greg S.56,Donaldson Scott H.7,Ratjen Felix89,Konstan Michael W.10,Simon Noah13,Rosenbluth Daniel B.11,Retsch-Bogart George12,Clancy John P.1314,VanDalfsen Jill M.1,Buckingham Rachael1,Gifford Alex H.1516ORCID

Affiliation:

1. Cystic Fibrosis Therapeutics Development Network Coordinating Center, Seattle Children’s Hospital, Seattle, Washington;

2. Department of Pediatrics and

3. Department of Biostatistics, University of Washington, Seattle, Washington;

4. Division of Pulmonary and Critical Care Medicine, Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, Maryland;

5. Division of General Pediatrics and Respiratory Diseases, Boston Children’s Hospital, Boston, Massachusetts;

6. Department of Pediatrics, Harvard Medical School, Harvard University, Boston, Massachusetts;

7. Division of Pulmonary and Critical Care Medicine and

8. Division of Respiratory Translational Medicine Program, SickKids Research Institute, Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada;

9. Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada;

10. Department of Pediatrics, Rainbow Babies and Children’s Hospital and School of Medicine, Case Western Reserve University, Cleveland, Ohio;

11. Division of Pulmonary and Critical Care Medicine, Department of Medicine, School of Medicine, Washington University, St. Louis, Missouri;

12. Division of Pediatric Pulmonology, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina;

13. Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio;

14. Cystic Fibrosis Foundation, Bethesda, Maryland;

15. Pulmonary and Critical Care Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire; and

16. The Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire

Publisher

American Thoracic Society

Subject

Pulmonary and Respiratory Medicine

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