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
