Cystic Fibrosis Clinical Trials

AeroVanc (SAV005-04) – NOW ENROLLING

A Phase III, randomized, double-blind, placebo-controlled study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus lung infection in cystic fibrosis patients (SAV005-04)

Protocol, purpose and description: This study is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent MRSA in patients with Cystic Fibrosis.

CHKD physicians involved: Laura Sass, MD; Cynthia Epstein, MD; Frank Chocano, MD

Learn more about this clinical trial.

Or contact Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org or

Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org

Tobramycin inhalation powder or other FDA approved inhaled antipseudomonal antibacterial drugs (CTBM100C2407) – NOW ENROLLING

A prospective observational study in cystic fibrosis patients with chronic respiratory Pseudomonas aeruginosa infection treated with TOBI® Podhaler™ (tobramycin inhalation powder) or other FDA approved inhaled antipseudomonal antibacterial drugs (CTBM100C2407)

Protocol, purpose and description: This is a multicenter, prospective, two cohort, observational study over a 5-year period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection. The study will collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on microbiological and safety assessments.

CHKD physicians involved: Laura Sass, MD; Cynthia Epstein, MD; Frank Chocano, MD

Learn more about this clinical trial.

 Or contact Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org or

Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org

A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) – NOW ENROLLING

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF) – VX17-445-102

Protocol, purpose and description: This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

CHKD physicians involved: Laura Sass, MD; Cynthia Epstein, MD; Frank Chocano, MD

Learn more about this clinical trial.

Or contact Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org or

Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org

A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy – ENROLLING SOON

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for F508del Mutation – VX17-445-105

Protocol, purpose and description: This study will evaluate the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation

CHKD physicians involved: Laura Sass, MD; Cynthia Epstein, MD; Frank Chocano, MD

Learn more about this clinical trial.

Or contact Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org or

Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org

Tezacaftor/Ivacaftor (VX16-661-114) – NOW ENROLLING

Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation  (VX16-661-114)

Protocol, purpose and description:Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the CFTR gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of TEZ/IVA.

CHKD physicians involved: Laura Sass, MD; Cynthia Epstein, MD; Frank Chocano, MD

Learn more about this study.

Or contact Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org or Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org

AeroVanc (SAV005-04) – NOW ENROLLING

A Phase III, randomized, double-blind, placebo-controlled study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus lung infection in cystic fibrosis patients (SAV005-04)

Protocol, purpose and description: This study is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent MRSA in patients with Cystic Fibrosis.

CHKD physicians involved: Laura Sass, MD;  Cynthia Epstein, MD; Frank Chocano, MD

Learn more about this study. 

Or contact Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org or Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org

Tobramycin inhalation powder or other FDA approved inhaled antipseudomonal antibacterial drugs (CTBM100C2407) – NOW ENROLLING

A prospective observational study in cystic fibrosis patients with chronic respiratory Pseudomonas aeruginosa infection treated with TOBI® Podhaler™ (tobramycin inhalation powder) or other FDA approved inhaled antipseudomonal antibacterial drugs (CTBM100C2407)

Protocol, purpose and description: This is a multicenter, prospective, two cohort, observational study over a 5-year period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection. The study will collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on microbiological and safety assessments.

CHKD physicians involved: Laura Sass, MD; Cynthia Epstein, MD; Frank Chocano, MD

Learn more about this study.

Or contact Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org or Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org

VX-661 in Combination With Ivacaftor (VX15-661-113)

A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation (VX15-661-113)

Protocol, purpose and description: This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the PK, safety, and tolerability of multiple doses of VX-661 in combination with ivacaftor in subjects 6 through 11 years of age with CF who are homozygous or heterozygous for the F508del-CFTR mutation.

CHKD physicians involved: Laura Sass, MD; Cynthia Epstein, MD; Frank Chocano, MD

Learn more about this study.

Or contact Erin McAndrews at (757) 668-6896 or at Erin.McAndrews@chkd.org or Jennifer Parrott at 757-668-8244 or Jennifer.Parrott@chkd.org

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