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Long-term safety and efficacy of tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study.
Flume PA, Biner RF, Downey DG, Brown C, Jain M, Fischer R, De Boeck K, Sawicki GS, Chang P, Paz-Diaz H, Rubin JL, Yang Y, Hu X, Pasta DJ, Millar SJ, Campbell D, Wang X, Ahluwalia N, Owen CA, Wainwright CE; VX14-661-110 study group. Flume PA, et al. Lancet Respir Med. 2021 Jul;9(7):733-746. doi: 10.1016/S2213-2600(20)30510-5. Epub 2021 Feb 10. Lancet Respir Med. 2021. PMID: 33581080
Here, we present results of study 661-110 (EXTEND), a 96-week open-label extension study that assessed long-term safety, tolerability, and efficacy of tezacaftor-ivacaftor in participants aged 12 years or older with cystic fibrosis who were homozygous or heterozygous for t …
Here, we present results of study 661-110 (EXTEND), a 96-week open-label extension study that assessed long-term safety, tolerability …
Practitioner Due Diligence: Real-World Lumacaftor/Ivacaftor Use.
Stephan EM, Nemastil CJ, Salvator A, Gemma S, Dilaveris CJ, Rice A, Sakellaris KT, Novak KJ, McCoy KS. Stephan EM, et al. Among authors: mccoy ks. J Pediatr Pharmacol Ther. 2020;25(5):431-436. doi: 10.5863/1551-6776-25.5.431. J Pediatr Pharmacol Ther. 2020. PMID: 32641913 Free PMC article.
However, this small reduction does not overcome the financial cost of treatment. Long-term outcomes and use must be studied to determine the overall effect of this therapy on cystic fibrosis interventions and their costs....
However, this small reduction does not overcome the financial cost of treatment. Long-term outcomes and use must be studied to determ …
The expression of Mirc1/Mir17-92 cluster in sputum samples correlates with pulmonary exacerbations in cystic fibrosis patients.
Krause K, Kopp BT, Tazi MF, Caution K, Hamilton K, Badr A, Shrestha C, Tumin D, Hayes D Jr, Robledo-Avila F, Hall-Stoodley L, Klamer BG, Zhang X, Partida-Sanchez S, Parinandi NL, Kirkby SE, Dakhlallah D, McCoy KS, Cormet-Boyaka E, Amer AO. Krause K, et al. Among authors: mccoy ks. J Cyst Fibros. 2018 Jul;17(4):454-461. doi: 10.1016/j.jcf.2017.11.005. Epub 2017 Dec 11. J Cyst Fibros. 2018. PMID: 29241629 Free PMC article.
Many patients with CF suffer from repeated pulmonary exacerbations that are predictors of worsened long-term morbidity and mortality. There are no reliable markers that associate with the onset or progression of an exacerbation or pulmonary deterioration. ...
Many patients with CF suffer from repeated pulmonary exacerbations that are predictors of worsened long-term morbidity and mortality. …
Pulmonary Artery Pressure and Benefit of Lung Transplantation in Adult Cystic Fibrosis Patients.
Hayes D Jr, Tumin D, Daniels CJ, McCoy KS, Mansour HM, Tobias JD, Kirkby SE. Hayes D Jr, et al. Among authors: mccoy ks. Ann Thorac Surg. 2016 Mar;101(3):1104-9. doi: 10.1016/j.athoracsur.2015.09.086. Epub 2015 Dec 11. Ann Thorac Surg. 2016. PMID: 26687141
A multivariate Cox model of survival since list entry including 1,336 patients found a protective but statistically insignificant benefit of LTx for patients whose MPAP at listing was 25 mm Hg (HR, 0.879; 95% confidence interval [CI], 0.657-1.177; p = 0.388), yet LTx was predicte …
A multivariate Cox model of survival since list entry including 1,336 patients found a protective but statistically insignificant benefit of …
Long term effects of denufosol tetrasodium in patients with cystic fibrosis.
Ratjen F, Durham T, Navratil T, Schaberg A, Accurso FJ, Wainwright C, Barnes M, Moss RB; TIGER-2 Study Investigator Group. Ratjen F, et al. J Cyst Fibros. 2012 Dec;11(6):539-49. doi: 10.1016/j.jcf.2012.05.003. Epub 2012 Jun 8. J Cyst Fibros. 2012. PMID: 22682898 Free article. Clinical Trial.
Results of a phase IIa study of VX-809, an investigational CFTR corrector compound, in subjects with cystic fibrosis homozygous for the F508del-CFTR mutation.
Clancy JP, Rowe SM, Accurso FJ, Aitken ML, Amin RS, Ashlock MA, Ballmann M, Boyle MP, Bronsveld I, Campbell PW, De Boeck K, Donaldson SH, Dorkin HL, Dunitz JM, Durie PR, Jain M, Leonard A, McCoy KS, Moss RB, Pilewski JM, Rosenbluth DB, Rubenstein RC, Schechter MS, Botfield M, Ordoñez CL, Spencer-Green GT, Vernillet L, Wisseh S, Yen K, Konstan MW. Clancy JP, et al. Among authors: mccoy ks. Thorax. 2012 Jan;67(1):12-8. doi: 10.1136/thoraxjnl-2011-200393. Epub 2011 Aug 8. Thorax. 2012. PMID: 21825083 Free PMC article. Clinical Trial.
Additional data are needed to determine how improvements detected in CFTR function secondary to VX-809 in the sweat gland relate to those measurable in the respiratory tract and to long-term measures of clinical benefit. CLINICAL TRIAL NUMBER: NCT00865904....
Additional data are needed to determine how improvements detected in CFTR function secondary to VX-809 in the sweat gland relate to those me …
Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis.
Retsch-Bogart GZ, Quittner AL, Gibson RL, Oermann CM, McCoy KS, Montgomery AB, Cooper PJ. Retsch-Bogart GZ, et al. Among authors: mccoy ks. Chest. 2009 May;135(5):1223-1232. doi: 10.1378/chest.08-1421. Chest. 2009. PMID: 19420195 Free PMC article. Clinical Trial.
BACKGROUND: We assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibiotic]) in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA) airway infection. ...
BACKGROUND: We assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibi …