Cystic Fibrosis Clinical Trials

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

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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