Chest
Original ResearchCystic FibrosisEffect of Azithromycin on Systemic Markers of Inflammation in Patients With Cystic Fibrosis Uninfected With Pseudomonas aeruginosa
Section snippets
Materials and Methods
Details of the AZ0004 study have been described elsewhere.18 The trial was conducted at 31 Cystic Fibrosis Foundation-accredited care centers in the United States and at nine Canadian Cystic Fibrosis Foundation-accredited care centers coordinated by the CF Therapeutics Development Network Coordinating Center located in Seattle, Washington. Respective institutional review boards and ethics committees at each center approved the study and each participant and/or their parent voluntarily
Results
Of the 324 participants screened for the AZ0004 study, 260 (80%) were randomized and treated; 131 were randomized to azithromycin and 129 to placebo.18 Of the 260 participants, all had inflammatory marker laboratory results for MPO, hsCRP, ICAM-1, IL-6, G-CSF, calprotectin, SAA, and ANC, but a small fraction of test results could not be used due to hemolysis. Baseline characteristics were similar between treatment groups, including baseline weight (kg and percentile), lung function (FEV1 L and
Discussion
To the best of our knowledge, this is the first large study to assess the utility of a panel of systemic inflammatory markers in an interventional trial of patients with CF who have preserved lung function. Patients treated with azithromycin exhibited significant reductions in inflammatory markers after 4 weeks that persisted (albeit to a lesser degree) to week 24. Reduction in inflammatory markers were correlated to improvements in lung function and weight gain, providing indirect evidence
Acknowledgments
Author contributions: Dr Ratjen is the guarantor of the manuscript and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Dr Ratgen: contributed to conception and design of the study; data acquisition, analysis, and interpretation; writing or revising the final manuscript for important intellectual content; and approval of the final manuscript; and served as principal author.
Dr Saiman: contributed to conception and design of the study; data acquisition,
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Funding/Support: This research was funded by the Cystic Fibrosis Foundation, and grants from the National Institutes of Health/National Heart, Lung and Blood Institute [Grant 1 U01 HL081335-01] and National Center for Research Resources [Grant 1 UL1 RR025780].
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