Randomized controlled study of aerosolized hypertonic xylitol versus hypertonic saline in hospitalized patients with pulmonary exacerbation of cystic fibrosis

Sachinkumar Singh; Douglas Hornick; Janel Fedler; Janice L Launspach; Mary E Teresi; Thomas R Santacroce; Joseph E Cavanaugh; Rebecca Horan; George Nelson; Timothy D Starner; Joseph Zabner; Lakshmi Durairaj

doi:10.1016/j.jcf.2019.06.016

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Randomized controlled study of aerosolized hypertonic xylitol versus hypertonic saline in hospitalized patients with pulmonary exacerbation of cystic fibrosis

Journal article

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Randomized controlled study of aerosolized hypertonic xylitol versus hypertonic saline in hospitalized patients with pulmonary exacerbation of cystic fibrosis

Sachinkumar Singh, Douglas Hornick, Janel Fedler, Janice L Launspach, Mary E Teresi, Thomas R Santacroce, Joseph E Cavanaugh, Rebecca Horan, George Nelson, Timothy D Starner, …

Journal of cystic fibrosis, Vol.19(1), pp.108-113

01/2020

DOI: 10.1016/j.jcf.2019.06.016

PMCID: PMC6980423

PMID: 31327670

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Abstract

Cystic fibrosis (CF) lung disease is characterized by chronic bacterial infection and recurrent pulmonary exacerbations. Xylitol is a 5-carbon sugar that can lower the airway surface salt concentration and augment innate immunity. We examined the safety and efficacy of aerosolized xylitol use for 2 weeks in subjects hospitalized with a pulmonary exacerbation of CF. In a 2-week study, 60 subjects with cystic fibrosis and FEV  > 30% predicted were enrolled to receive aerosolized 7% hypertonic saline (4 ml) or 15% xylitol (5 ml) twice a day for 14 days. Outcomes assessed included change from baseline in FEV % predicted, change in sputum microbial density, revised CF quality of life questionnaire including the respiratory symptom score, time to next hospitalization for a pulmonary exacerbation, and frequency of adverse events. 59 subjects completed the study (one subject in the saline group withdrew before any study product administration). No significant differences were noted between the 2 arms in mean changes in lung function, sputum microbial density for Pseudomonas aeruginosa and Staphylococcus aureus, body weight, quality of life, and frequency of adverse events. Aerosolized hypertonic xylitol was well-tolerated among subjects hospitalized for CF pulmonary exacerbation. Future studies examining efficacy for long term use in patients with CF lung disease would be worthwhile. The clinical trial registration number for this study is NCT00928135.

Exacerbations

Lung function

Sputum microbial density

Respiratory symptom score

Quality of life

Details

Title: Subtitle: Randomized controlled study of aerosolized hypertonic xylitol versus hypertonic saline in hospitalized patients with pulmonary exacerbation of cystic fibrosis
Creators: Sachinkumar Singh - Stead Family Department of Pediatrics, Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA
Douglas Hornick - Department of Internal Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA
Janel Fedler - Department of Biostatistics, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Janice L Launspach - Department of Internal Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA
Mary E Teresi - Stead Family Department of Pediatrics, Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA
Thomas R Santacroce - Walter Reed National Military Medical Center, Bethesda, MD 20889, USA
Joseph E Cavanaugh - Department of Biostatistics, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Rebecca Horan - Department of Internal Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA
George Nelson - Doris Duke Clinical Research Scholar, University of Iowa, USA
Timothy D Starner - Department of Pediatrics, University of Wisconsin-Madison, 600 Highland Ave, Madison, WI 53792, USA
Joseph Zabner - Department of Internal Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA
Lakshmi Durairaj - Department of Internal Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA. Electronic address: lakshmi-durairaj@uiowa.edu
Resource Type: Journal article
Publication Details: Journal of cystic fibrosis, Vol.19(1), pp.108-113
DOI: 10.1016/j.jcf.2019.06.016
PMID: 31327670
PMCID: PMC6980423
NLM abbreviation: J Cyst Fibros
ISSN: 1569-1993
eISSN: 1873-5010
Grant note: P30 ES005605 / NIEHS NIH HHS UL1 TR002537 / NCATS NIH HHS P30 DK054759 / NIDDK NIH HHS U01 HL102288 / NHLBI NIH HHS
Language: English
Date published: 01/2020
Academic Unit: Statistics and Actuarial Science; Pulmonary, Critical Care, and Occupational Medicine; Stead Family Department of Pediatrics; Biostatistics; Injury Prevention Research Center; Internal Medicine
Record Identifier: 9984214680402771

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