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Lung Function Decline in Cystic Fibrosis: Impact of Data Availability and Modeling Strategies on Clinical Interpretations.
Szczesniak R, Andrinopoulou ER, Su W, Afonso PM, Burgel PR, Cromwell E, Gecili E, Ghulam E, Goss CH, Mayer-Hamblett N, Keogh RH, Liou TG, Marshall B, Morgan WJ, Ostrenga JS, Pasta DJ, Stanojevic S, Wainwright C, Zhou GC, Fernandez G, Fink AK, Schechter MS. Szczesniak R, et al. Among authors: mayer hamblett n. Ann Am Thorac Soc. 2023 Jul;20(7):958-968. doi: 10.1513/AnnalsATS.202209-829OC. Ann Am Thorac Soc. 2023. PMID: 36884219
Marginal models consistently estimated less rapid lung function decline than mixed-effects models across scenarios, except for short-term follow-up (both were 1.4). Rate of decline estimates from nonlinear models diverged by age 30. ...Conclusions: Differences were as high …
Marginal models consistently estimated less rapid lung function decline than mixed-effects models across scenarios, except for short-term …
Evaluating the Impact of Stopping Chronic Therapies after Modulator Drug Therapy in Cystic Fibrosis: The SIMPLIFY Clinical Trial Study Design.
Mayer-Hamblett N, Nichols DP, Odem-Davis K, Riekert KA, Sawicki GS, Donaldson SH, Ratjen F, Konstan MW, Simon N, Rosenbluth DB, Retsch-Bogart G, Clancy JP, VanDalfsen JM, Buckingham R, Gifford AH. Mayer-Hamblett N, et al. Ann Am Thorac Soc. 2021 Aug;18(8):1397-1405. doi: 10.1513/AnnalsATS.202010-1336SD. Ann Am Thorac Soc. 2021. PMID: 33465316 Free PMC article.
The protocol is composed of two concurrent randomized controlled trials designed to evaluate the independent short-term effects of discontinuing hypertonic saline or dornase alfa, enabling individuals on both therapies to participate in one or both trials. ...
The protocol is composed of two concurrent randomized controlled trials designed to evaluate the independent short-term effects of di …
Long-term azithromycin use is not associated with QT prolongation in children with cystic fibrosis.
Magaret AS, Salerno J, Deen JF, Kloster M, Mayer-Hamblett N, Ramsey BW, Nichols DP. Magaret AS, et al. Among authors: mayer hamblett n. J Cyst Fibros. 2021 Mar;20(2):e16-e18. doi: 10.1016/j.jcf.2020.11.005. Epub 2020 Nov 24. J Cyst Fibros. 2021. PMID: 33246911 Free PMC article.
Among 221 study participants with a median of 18 months follow-up, increased corrected QT interval (QTc) of 30 msec was rare, at 3.4 occurrences per 100 person-years; and incidence of QTc prolongation was no higher in the AZM arm than the placebo arm (1.8 versus 5.4 per 100 perso …
Among 221 study participants with a median of 18 months follow-up, increased corrected QT interval (QTc) of 30 msec was rare, at 3.4 occurre …
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.
Konstan MW, McKone EF, Moss RB, Marigowda G, Tian S, Waltz D, Huang X, Lubarsky B, Rubin J, Millar SJ, Pasta DJ, Mayer-Hamblett N, Goss CH, Morgan W, Sawicki GS. Konstan MW, et al. Among authors: mayer hamblett n. Lancet Respir Med. 2017 Feb;5(2):107-118. doi: 10.1016/S2213-2600(16)30427-1. Epub 2016 Dec 21. Lancet Respir Med. 2017. PMID: 28011037 Clinical Trial.
BACKGROUND: The 24-week safety and efficacy of lumacaftor/ivacaftor combination therapy was shown in two randomised controlled trials (RCTs)-TRAFFIC and TRANSPORT-in patients with cystic fibrosis who were aged 12 years or older and homozygous for the F508del-CFTR mutation. We aim …
BACKGROUND: The 24-week safety and efficacy of lumacaftor/ivacaftor combination therapy was shown in two randomised controlled trials (RCTs) …
Impact of Sustained Eradication of New Pseudomonas aeruginosa Infection on Long-term Outcomes in Cystic Fibrosis.
Mayer-Hamblett N, Kloster M, Rosenfeld M, Gibson RL, Retsch-Bogart GZ, Emerson J, Thompson V, Ramsey BW. Mayer-Hamblett N, et al. Clin Infect Dis. 2015 Sep 1;61(5):707-15. doi: 10.1093/cid/civ377. Epub 2015 May 13. Clin Infect Dis. 2015. PMID: 25972024 Free PMC article. Clinical Trial.
A key question is whether children with newly acquired Pa infection who are able to achieve sustained eradication after early antipseudomonal therapy demonstrate improved long-term health outcomes compared with those who are unable to achieve a sustained microbiologic resp …
A key question is whether children with newly acquired Pa infection who are able to achieve sustained eradication after early antipseudomona …
Lack of association of small-colony-variant Staphylococcus aureus strains with long-term use of azithromycin in patients with cystic fibrosis.
Green N, Burns JL, Mayer-Hamblett N, Kloster M, Lands LC, Anstead M, Ratjen F, Saiman L. Green N, et al. Among authors: mayer hamblett n. J Clin Microbiol. 2011 Jul;49(7):2772-3. doi: 10.1128/JCM.00835-11. Epub 2011 May 4. J Clin Microbiol. 2011. PMID: 21543567 Free PMC article. Clinical Trial. No abstract available.
Shifting patterns of inhaled antibiotic use in cystic fibrosis.
Moskowitz SM, Silva SJ, Mayer-Hamblett N, Pasta DJ, Mink DR, Mabie JA, Konstan MW, Wagener JS; Investigators and Coordinators of the Epidemiologic Study of Cystic Fibrosis (ESCF). Moskowitz SM, et al. Among authors: mayer hamblett n. Pediatr Pulmonol. 2008 Sep;43(9):874-81. doi: 10.1002/ppul.20873. Pediatr Pulmonol. 2008. PMID: 18668689
CONCLUSIONS: Increased chronic use and decreased acute use of inhaled antibiotics presumably reflect a shift toward more proactive management of airway infections in the North American CF population. The effects of these usage patterns on long-term clinical outcomes and em …
CONCLUSIONS: Increased chronic use and decreased acute use of inhaled antibiotics presumably reflect a shift toward more proactive managemen …
Heterogeneity of treatment response to azithromycin in patients with cystic fibrosis.
Saiman L, Mayer-Hamblett N, Campbell P, Marshall BC; Macrolide Study Group. Saiman L, et al. Among authors: mayer hamblett n. Am J Respir Crit Care Med. 2005 Oct 15;172(8):1008-12. doi: 10.1164/rccm.200502-218OC. Epub 2005 Jul 22. Am J Respir Crit Care Med. 2005. PMID: 16040785 Clinical Trial.
Pulmonary function and exacerbation responses were compared in subgroups of participants characterized by long-term concomitant medications and baseline lung function. MEASUREMENTS: All available data from the 185 randomized participants in the azithromycin trial were incl …
Pulmonary function and exacerbation responses were compared in subgroups of participants characterized by long-term concomitant medic …
Developing cystic fibrosis lung transplant referral criteria using predictors of 2-year mortality.
Mayer-Hamblett N, Rosenfeld M, Emerson J, Goss CH, Aitken ML. Mayer-Hamblett N, et al. Am J Respir Crit Care Med. 2002 Dec 15;166(12 Pt 1):1550-5. doi: 10.1164/rccm.200202-087OC. Epub 2002 Aug 15. Am J Respir Crit Care Med. 2002. PMID: 12406843
Transplant referral decisions based either on a multivariate logistic model or on the criterion of an FEV1 of less than 30% predicted are likely to result in high rates of premature referral. Better clinical predictors of short-term mortality among patients with CF are nee …
Transplant referral decisions based either on a multivariate logistic model or on the criterion of an FEV1 of less than 30% predicted are li …