Publications by authors named "David Waltz"

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Long-Term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Adults and Adolescents with Cystic Fibrosis and at Least One Allele: A Phase 3 Open-Label Extension Study.
Cori L Daines, Deepika Polineni, Elizabeth Tullis, Stefano Costa, Rachel W Linnemann, David Waltz

Am J Respir Crit Care Med· October 2025

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Long-Term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Children ≥6 Years with Cystic Fibrosis and at Least One Allele: A 192-Week, Phase 3, Open-Label Extension Study.
Claire Wainwright, Susanna A McColley, Paul McNally, Michael Powers, Felix Ratjen, David Waltz

Am J Respir Crit Care Med· October 2025

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Sweat chloride reflects CFTR function and correlates with clinical outcomes following CFTR modulator treatment.
Edith T Zemanick, Bonnie Ramsey, Dorota Sands, Edward F McKone, Isabelle Fajac, David Waltz

J Cyst Fibros· March 2025

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Elexacaftor/Tezacaftor/Ivacaftor Treatment and Depression-related Events.
Bonnie Ramsey, Christoph U Correll, David R DeMaso, Edward McKone, Elizabeth Tullis, David Waltz

Am J Respir Crit Care Med· February 2024

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Long-Term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Children Aged ⩾6 Years with Cystic Fibrosis and at Least One Allele: A Phase 3, Open-Label Clinical Trial.
Claire Wainwright, Susanna A McColley, Paul McNally, Michael Powers, Felix Ratjen, David Waltz

Am J Respir Crit Care Med· July 2023

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Safety and efficacy of vanzacaftor-tezacaftor-deutivacaftor in adults with cystic fibrosis: randomised, double-blind, controlled, phase 2 trials.
Ahmet Z Uluer, Gordon MacGregor, Pilar Azevedo, Veronica Indihar, Claire Keating, David Waltz

Lancet Respir Med· June 2023

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Efficacy and safety of elexacaftor plus tezacaftor plus ivacaftor versus tezacaftor plus ivacaftor in people with cystic fibrosis homozygous for F508del-CFTR: a 24-week, multicentre, randomised, double-blind, active-controlled, phase 3b trial.
Sivagurunathan Sutharsan, Edward F McKone, Damian G Downey, Jamie Duckers, Gordon MacGregor, David Waltz

Lancet Respir Med· March 2022

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Triple Therapy for Cystic Fibrosis -Gating and -Residual Function Genotypes.
Peter J Barry, Marcus A Mall, Antonio Álvarez, Carla Colombo, Karin M de Winter-de Groot, David Waltz

N Engl J Med· August 2021

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A Phase 3 Open-Label Study of Elexacaftor/Tezacaftor/Ivacaftor in Children 6 through 11 Years of Age with Cystic Fibrosis and at Least One Allele.
Edith T Zemanick, Jennifer L Taylor-Cousar, Jane Davies, Ronald L Gibson, Marcus A Mall, David Waltz

Am J Respir Crit Care Med· June 2021

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Transparency and diversity in cystic fibrosis research - Authors' reply.
Karen S McCoy, Harry Heijerman, Jennifer L Taylor-Cousar, David Waltz, Patrick R Sosnay

Lancet· August 2020

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Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial.
Harry G M Heijerman, Edward F McKone, Damian G Downey, Eva Van Braeckel, Steven M Rowe, David Waltz

Lancet· November 2019

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Elexacaftor-Tezacaftor-Ivacaftor for Cystic Fibrosis with a Single Phe508del Allele.
Peter G Middleton, Marcus A Mall, Pavel Dřevínek, Larry C Lands, Edward F McKone, David Waltz

N Engl J Med· November 2019

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Safety, pharmacokinetics, and pharmacodynamics of lumacaftor and ivacaftor combination therapy in children aged 2-5 years with cystic fibrosis homozygous for F508del-CFTR: an open-label phase 3 study.
John J McNamara, Susanna A McColley, Gautham Marigowda, Fang Liu, Simon Tian, David Waltz

Lancet Respir Med· April 2019

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Clinical development of triple-combination CFTR modulators for cystic fibrosis patients with one or two alleles.
Jennifer L Taylor-Cousar, Marcus A Mall, Bonnie W Ramsey, Edward F McKone, Elizabeth Tullis, David Waltz

ERJ Open Res· April 2019

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Lumacaftor/Ivacaftor reduces pulmonary exacerbations in patients irrespective of initial changes in FEV.
Susanna A McColley, Michael W Konstan, Bonnie W Ramsey, J Stuart Elborn, Michael P Boyle, David Waltz

J Cyst Fibros· January 2019

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VX-445-Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles.
Dominic Keating, Gautham Marigowda, Lucy Burr, Cori Daines, Marcus A Mall, David Waltz

N Engl J Med· October 2018

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VX-659-Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles.
Jane C Davies, Samuel M Moskowitz, Cynthia Brown, Alexander Horsley, Marcus A Mall, David Waltz

N Engl J Med· October 2018

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Hypertonic saline has a prolonged effect on mucociliary clearance in adults with cystic fibrosis.
Aaron T Trimble, A Whitney Brown, Beth L Laube, Noah Lechtzin, Kirby L Zeman, David Waltz

J Cyst Fibros· September 2018

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Lumacaftor/ivacaftor in patients with cystic fibrosis and advanced lung disease homozygous for F508del-CFTR.
Jennifer L Taylor-Cousar, Manu Jain, Tara Lynn Barto, Tarik Haddad, Jeffrey Atkinson, David Waltz

J Cyst Fibros· March 2018

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Efficacy and safety of lumacaftor and ivacaftor in patients aged 6-11 years with cystic fibrosis homozygous for F508del-CFTR: a randomised, placebo-controlled phase 3 trial.
Felix Ratjen, Christopher Hug, Gautham Marigowda, Simon Tian, Xiaohong Huang, David Waltz

Lancet Respir Med· July 2017

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Lumacaftor/Ivacaftor in Patients Aged 6-11 Years with Cystic Fibrosis and Homozygous for F508del-CFTR.
Carlos E Milla, Felix Ratjen, Gautham Marigowda, Fang Liu, David Waltz

Am J Respir Crit Care Med· April 2017

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Effect of bronchodilators in healthy individuals receiving lumacaftor/ivacaftor combination therapy.
Gautham Marigowda, Fang Liu, David Waltz

J Cyst Fibros· March 2017

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Lumacaftor/Ivacaftor Treatment of Patients with Cystic Fibrosis Heterozygous for F508del-CFTR.
Steven M Rowe, Susanna A McColley, Ernst Rietschel, Xiaolei Li, Scott C Bell, David Waltz

Ann Am Thorac Soc· February 2017

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Assessment of safety and efficacy of long-term treatment with combination lumacaftor and ivacaftor therapy in patients with cystic fibrosis homozygous for the F508del-CFTR mutation (PROGRESS): a phase 3, extension study.
Michael W Konstan, Edward F McKone, Richard B Moss, Gautham Marigowda, Simon Tian, David Waltz

Lancet Respir Med· February 2017

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Efficacy and safety of lumacaftor/ivacaftor combination therapy in patients with cystic fibrosis homozygous for Phe508del CFTR by pulmonary function subgroup: a pooled analysis.
J Stuart Elborn, Bonnie W Ramsey, Michael P Boyle, Michael W Konstan, Xiaohong Huang, David Waltz

Lancet Respir Med· August 2016

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