Nicole Mayer-Hamblett

Summary

Affiliation: University of Washington
Country: USA

Publications

  1. ncbi request reprint Impact of acute antibiotic therapy on the pulmonary exacerbation endpoint in cystic fibrosis clinical trials
    Nicole Mayer-Hamblett
    Department of Pediatrics and Biostatistics, University of Washington, Seattle, WA, USA
    Contemp Clin Trials 36:99-105. 2013
  2. doi request reprint Incidence and clinical significance of elevated liver function tests in cystic fibrosis clinical trials
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Seattle, WA 98101 9300, USA
    Contemp Clin Trials 34:232-8. 2013
  3. pmc Initial Pseudomonas aeruginosa treatment failure is associated with exacerbations in cystic fibrosis
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Seattle, Washington Seattle Children s Hospital, Seattle, Washington, USA
    Pediatr Pulmonol 47:125-34. 2012
  4. pmc Advancing outcome measures for the new era of drug development in cystic fibrosis
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Seattle, WA 98105 0371, USA
    Proc Am Thorac Soc 4:370-7. 2007
  5. pmc Association between pulmonary function and sputum biomarkers in cystic fibrosis
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, 4800 Sand Point Way N E, Box 5371, Seattle, WA 98105 0371, USA
    Am J Respir Crit Care Med 175:822-8. 2007
  6. ncbi request reprint Improving the estimation of change from baseline in a continuous outcome measure in the clinical trial setting
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Box 5371, CL 11, Seattle, WA 98195, USA
    Contemp Clin Trials 26:2-16. 2005
  7. pmc Early anti-pseudomonal acquisition in young patients with cystic fibrosis: rationale and design of the EPIC clinical trial and observational study'
    Miriam M Treggiari
    Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA 98104, USA
    Contemp Clin Trials 30:256-68. 2009
  8. doi request reprint Effect of azithromycin on pulmonary function in patients with cystic fibrosis uninfected with Pseudomonas aeruginosa: a randomized controlled trial
    Lisa Saiman
    Columbia University, Department of Pediatrics, 650 W 168th St, PH 4 West, Room 420, New York, NY 10032, USA
    JAMA 303:1707-15. 2010
  9. doi request reprint Open-label, follow-on study of azithromycin in pediatric patients with CF uninfected with Pseudomonas aeruginosa
    Lisa Saiman
    Department of Pediatrics, Columbia University, New York, New York 10032, USA
    Pediatr Pulmonol 47:641-8. 2012
  10. ncbi request reprint Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Seattle, Washington Seattle Children s Hospital, Seattle, Washington
    Pediatr Pulmonol 48:943-53. 2013

Detail Information

Publications31

  1. ncbi request reprint Impact of acute antibiotic therapy on the pulmonary exacerbation endpoint in cystic fibrosis clinical trials
    Nicole Mayer-Hamblett
    Department of Pediatrics and Biostatistics, University of Washington, Seattle, WA, USA
    Contemp Clin Trials 36:99-105. 2013
    ..Our hypothesis was that acute antibiotics given for illnesses not meeting the PE definition may alter estimates of treatment effect that do not account for this antibiotic use...
  2. doi request reprint Incidence and clinical significance of elevated liver function tests in cystic fibrosis clinical trials
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Seattle, WA 98101 9300, USA
    Contemp Clin Trials 34:232-8. 2013
    ..The objectives of this study were to characterize emergence rates of elevated LFTs in CF trials and their association with clinical outcomes...
  3. pmc Initial Pseudomonas aeruginosa treatment failure is associated with exacerbations in cystic fibrosis
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Seattle, Washington Seattle Children s Hospital, Seattle, Washington, USA
    Pediatr Pulmonol 47:125-34. 2012
    ..The risk of pulmonary exacerbation following Pseudomonas aeruginosa (Pa) acquisition in children with cystic fibrosis (CF) is unknown...
  4. pmc Advancing outcome measures for the new era of drug development in cystic fibrosis
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Seattle, WA 98105 0371, USA
    Proc Am Thorac Soc 4:370-7. 2007
    ..A systematic, rigorous approach to outcome measure development is needed to provide the tools necessary for evaluating new therapies and moving drugs out of the pipeline and into the CF clinic...
  5. pmc Association between pulmonary function and sputum biomarkers in cystic fibrosis
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, 4800 Sand Point Way N E, Box 5371, Seattle, WA 98105 0371, USA
    Am J Respir Crit Care Med 175:822-8. 2007
    ..Validation of these biomarkers as correlates of disease severity is a key step for their application...
  6. ncbi request reprint Improving the estimation of change from baseline in a continuous outcome measure in the clinical trial setting
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Box 5371, CL 11, Seattle, WA 98195, USA
    Contemp Clin Trials 26:2-16. 2005
    ..We are motivated by examples in the cystic fibrosis (CF) clinical trial setting and demonstrate the potential for this approach in reducing the sample size required for future CF clinical trials...
  7. pmc Early anti-pseudomonal acquisition in young patients with cystic fibrosis: rationale and design of the EPIC clinical trial and observational study'
    Miriam M Treggiari
    Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA 98104, USA
    Contemp Clin Trials 30:256-68. 2009
    ..Risk factors for and clinical impact of early Pa infection in young CF patients are less well understood...
  8. doi request reprint Effect of azithromycin on pulmonary function in patients with cystic fibrosis uninfected with Pseudomonas aeruginosa: a randomized controlled trial
    Lisa Saiman
    Columbia University, Department of Pediatrics, 650 W 168th St, PH 4 West, Room 420, New York, NY 10032, USA
    JAMA 303:1707-15. 2010
    ..Azithromycin is recommended as therapy for cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection, but there has not been sufficient evidence to support the benefit of azithromycin in other patients with CF...
  9. doi request reprint Open-label, follow-on study of azithromycin in pediatric patients with CF uninfected with Pseudomonas aeruginosa
    Lisa Saiman
    Department of Pediatrics, Columbia University, New York, New York 10032, USA
    Pediatr Pulmonol 47:641-8. 2012
    ..We now report the results of the open-label, follow-on study to assess durability of response to azithromycin and continued safety and tolerability...
  10. ncbi request reprint Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Seattle, Washington Seattle Children s Hospital, Seattle, Washington
    Pediatr Pulmonol 48:943-53. 2013
    ....
  11. doi request reprint Comparative efficacy and safety of 4 randomized regimens to treat early Pseudomonas aeruginosa infection in children with cystic fibrosis
    Miriam M Treggiari
    Department of Anesthesiology and Pain Medicine, Seattle Children s Hospital, WA 98104, USA
    Arch Pediatr Adolesc Med 165:847-56. 2011
    ..To investigate the efficacy and safety of 4 antipseudomonal treatments in children with cystic fibrosis with recently acquired Pseudomonas aeruginosa infection...
  12. ncbi request reprint Azithromycin in patients with cystic fibrosis chronically infected with Pseudomonas aeruginosa: a randomized controlled trial
    Lisa Saiman
    Department of Pediatrics, Columbia University College of Physicians and Surgeons, New York, NY 10032 3784, USA
    JAMA 290:1749-56. 2003
    ..Treatment strategies for cystic fibrosis (CF) lung disease include antibiotics, mucolytics, and anti-inflammatory therapies. Increasing evidence suggests that macrolide antibiotics might be beneficial in patients with CF...
  13. ncbi request reprint Laboratory parameter profiles among patients with cystic fibrosis
    Christopher H Goss
    Department of Medicine, University of Washington Medical Center, Seattle, WA 98195, USA
    J Cyst Fibros 6:117-23. 2007
    ..Laboratory-specific normal reference ranges may not accurately reflect what is abnormal but clinically insignificant among CF patients...
  14. ncbi request reprint Randomized, double-blind, placebo-controlled, dose-escalating study of aerosolized interferon gamma-1b in patients with mild to moderate cystic fibrosis lung disease
    Richard B Moss
    Department of Pediatrics, Stanford University Medical Center, Palo Alto, California 94304 5786, USA
    Pediatr Pulmonol 39:209-18. 2005
    ..Aerosolized IFN-gamma1b did not improve pulmonary function, reduce sputum bacterial density, or affect inflammatory sputum markers in patients with mild-moderate lung disease...
  15. pmc Risk of post-lung transplant renal dysfunction in adults with cystic fibrosis
    Bradley S Quon
    Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Washington, Seattle, WA 98195, USA
    Chest 142:185-91. 2012
    ..Cystic fibrosis (CF) is one of the leading indications for lung transplantation. The incidence and pre-lung transplant risk factors for posttransplant renal dysfunction in the CF population remain undefined...
  16. ncbi request reprint Duration of treatment effect after tobramycin solution for inhalation in young children with cystic fibrosis
    Ronald L Gibson
    Department of Pediatrics, University of Washington Children s Hospital and Regional Medical Center, Seattle, WA 98105 0371, USA
    Pediatr Pulmonol 42:610-23. 2007
    ..Early intervention strategies include tobramycin solution for inhalation (TSI), which can eradicate lower airway Pa from cultures obtained at the end of 28 days of treatment in young children...
  17. ncbi request reprint Inflammatory and microbiologic markers in induced sputum after intravenous antibiotics in cystic fibrosis
    Claudia L Ordonez
    Department of Pediatrics, Harvard Medical School, Boston, MA 02215, USA
    Am J Respir Crit Care Med 168:1471-5. 2003
    ..Seven of 127 (6%) sputum induction procedures showed a decrease in FEV1 of 20% or more. We conclude that markers in induced sputum may be useful, noninvasive outcome measures to assess response to therapies in cystic fibrosis studies...
  18. ncbi request reprint Clinical response to azithromycin in cystic fibrosis correlates with in vitro effects on Pseudomonas aeruginosa phenotypes
    Dao Nguyen
    Children s Hospital and Regional Medical Center, Seattle, Washington, USA
    Pediatr Pulmonol 42:533-41. 2007
    ..The in vitro effect of AZM on PLC correlates with FEV(1) response to AZM. This suggests that AZM anti-virulence effects may be predictive of clinical response and play a role in the mechanism of action of AZM in CF patients...
  19. pmc Risk factors for chronic kidney disease in adults with cystic fibrosis
    Bradley S Quon
    Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Washington, Seattle, WA 98195, USA
    Am J Respir Crit Care Med 184:1147-52. 2011
    ..Adults with cystic fibrosis (CF) possess multiple potential risk factors for chronic kidney disease, including CF-related diabetes (CFRD) and lifetime nephrotoxic drug exposure...
  20. ncbi request reprint Risk factors for first cerebrospinal fluid shunt infection: findings from a multi-center prospective cohort study
    Tamara D Simon
    Department of Pediatrics, University of Washington Seattle Children s Hospital, Seattle, WA Center for Clinical and Translational Research, Seattle Children s Research Institute, Seattle, WA Electronic address
    J Pediatr 164:1462-1468.e2. 2014
    ..To quantify the extent to which cerebrospinal fluid (CSF) shunt revisions are associated with increased risk of CSF shunt infection, after adjusting for patient factors that may contribute to infection risk...
  21. ncbi request reprint Developing cystic fibrosis lung transplant referral criteria using predictors of 2-year mortality
    Nicole Mayer-Hamblett
    Department of Pediatrics, University of Washington, Seattle, Washington 98105 0371, USA
    Am J Respir Crit Care Med 166:1550-5. 2002
    ..Better clinical predictors of short-term mortality among patients with CF are needed...
  22. pmc Use of phage display to identify potential Pseudomonas aeruginosa gene products relevant to early cystic fibrosis airway infections
    Christiane Beckmann
    Infectious Diseases Section, Children s Hospital and Regional Medical Center, 307 Westlake Ave N, Suite 300, Seattle, WA 98109, USA
    Infect Immun 73:444-52. 2005
    ..These results demonstrate the feasibility and validity of this novel approach and suggest potential targets for future development...
  23. pmc Disparities in access to lung transplantation for patients with cystic fibrosis by socioeconomic status
    Bradley S Quon
    University of Washington Medical Center, BB 1327, 1959 NE Pacific Street, Seattle, WA 98195, USA
    Am J Respir Crit Care Med 186:1008-13. 2012
    ....
  24. doi request reprint Reproducibility of spirometry during cystic fibrosis pulmonary exacerbations
    Don B Sanders
    Pediatric Pulmonary Division, Department of Pediatrics, Children s Hospital and Regional Medical Center, University of Washington, Seattle, Washington 98105, USA
    Pediatr Pulmonol 43:1142-6. 2008
    ..To compare the within day variation of spirometry between hospital admission, discharge, and outpatient follow up among children with cystic fibrosis (CF) hospitalized for a pulmonary exacerbation...
  25. doi request reprint Evaluation of microbial bacterial and fungal diversity in cerebrospinal fluid shunt infection
    Tamara D Simon
    Department of Pediatrics, University of Washington Seattle Children s Hospital, Seattle, Washington, United States of America Center for Clinical and Translational Research, Seattle Children s Research Institute, Seattle, Washington, United States of America
    PLoS ONE 9:e83229. 2014
    ..Improved diagnostic and therapeutic approaches are required, and culture-independent molecular approaches to cerebrospinal fluid shunt infections have not been described...
  26. doi request reprint Shifting patterns of inhaled antibiotic use in cystic fibrosis
    Samuel M Moskowitz
    Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington 98195 7740, USA
    Pediatr Pulmonol 43:874-81. 2008
    ..Our working hypothesis was that a shift from acute to chronic use of inhaled antibiotics has coincided with increased prevalence of use among CF patients...
  27. pmc Association of intraventricular hemorrhage secondary to prematurity with cerebrospinal fluid shunt surgery in the first year following initial shunt placement
    Tamara D Simon
    Department of Pediatrics, University of Washington Seattle Children s Hospital, Seattle, Washington, USA
    J Neurosurg Pediatr 9:54-63. 2012
    ..The object of this study was to identify baseline factors at the time of initial CSF shunt placement that are independently associated with subsequent surgery...
  28. pmc No detectable improvements in cystic fibrosis transmembrane conductance regulator by nasal aminoglycosides in patients with cystic fibrosis with stop mutations
    John P Clancy
    Department of Pediatrics, University of Alabama at Birmingham, 1600 7th Avenue South, Birmingham, AL 35233, USA
    Am J Respir Cell Mol Biol 37:57-66. 2007
    ..The study provides valuable information on parameters of the nasal potential difference measurements for use in future multicenter clinical trials...
  29. pmc Correlation between an in vitro invasion assay and a murine model of Burkholderia cepacia lung infection
    Martin V Cieri
    Division of Infectious Disease, Children s Hospital and Regional Medical Center, Seattle, Washington 98105, USA
    Infect Immun 70:1081-6. 2002
    ..Correlation between the models for six strains was demonstrated. Our results indicate that a statistical model used to determine invasiveness in an in vitro invasion assay can be used to predict in vivo invasiveness...
  30. ncbi request reprint Heterogeneity of treatment response to azithromycin in patients with cystic fibrosis
    Lisa Saiman
    Department of Pediatics, Columbia University, NY 10032, USA
    Am J Respir Crit Care Med 172:1008-12. 2005
    ..2% improvement in the 168-d relative change in FEV1 among azithromycin participants compared with placebo participants...
  31. ncbi request reprint Susceptibility testing of Pseudomonas aeruginosa isolates and clinical response to parenteral antibiotic administration: lack of association in cystic fibrosis
    Arnold L Smith
    Seattle Biomedical Research Institute, WA 98109, USA
    Chest 123:1495-502. 2003
    ..The susceptibility of the P aeruginosa isolates to ceftazidime and tobramycin was determined at trial enrollment by broth microdilution...