The Effect of Azithromycin in Adults with Stable Neutrophilic COPD: A Double Blind Randomised, Placebo Controlled Trial
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{"title"=>"The effect of azithromycin in adults with stable neutrophilic COPD: A double blind randomised, placebo controlled trial", "type"=>"journal", "authors"=>[{"first_name"=>"Jodie L.", "last_name"=>"Simpson", "scopus_author_id"=>"7404326026"}, {"first_name"=>"Heather", "last_name"=>"Powell", "scopus_author_id"=>"7101711366"}, {"first_name"=>"Katherine J.", "last_name"=>"Baines", "scopus_author_id"=>"35078051200"}, {"first_name"=>"David", "last_name"=>"Milne", "scopus_author_id"=>"7102931866"}, {"first_name"=>"Harvey O.", "last_name"=>"Coxson", "scopus_author_id"=>"6603681233"}, {"first_name"=>"Philip M.", "last_name"=>"Hansbro", "scopus_author_id"=>"6603119390"}, {"first_name"=>"Peter G.", "last_name"=>"Gibson", "scopus_author_id"=>"7202414199"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"scopus"=>"2-s2.0-84921001401", "sgr"=>"84921001401", "issn"=>"19326203", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "pmid"=>"25148049", "doi"=>"10.1371/journal.pone.0105609", "pui"=>"373802046"}, "id"=>"b9f1598c-ce37-3a25-904b-387a1dc4b5bd", "abstract"=>"BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is a progressive airway disease characterised by neutrophilic airway inflammation or bronchitis. Neutrophilic bronchitis is associated with both bacterial colonisation and lung function decline and is common in exacerbations of COPD. Despite current available therapies to control inflammation, neutrophilic bronchitis remains common. This study tested the hypothesis that azithromycin treatment, as an add-on to standard medication, would significantly reduce airway neutrophil and neutrophils chemokine (CXCL8) levels, as well as bacterial load. We conducted a randomised, double-blind, placebo-controlled study in COPD participants with stable neutrophilic bronchitis.\\n\\nMETHODS: Eligible participants (n = 30) were randomised to azithromycin 250 mg daily or placebo for 12 weeks in addition to their standard respiratory medications. Sputum was induced at screening, randomisation and monthly for a 12 week treatment period and processed for differential cell counts, CXCL8 and neutrophil elastase assessment. Quantitative bacteriology was assessed in sputum samples at randomisation and the end of treatment visit. Severe exacerbations where symptoms increased requiring unscheduled treatment were recorded during the 12 week treatment period and for 14 weeks following treatment. A sub-group of participants underwent chest computed tomography scans (n = 15).\\n\\nRESULTS: Nine participants with neutrophilic bronchitis had a potentially pathogenic bacteria isolated and the median total bacterial load of all participants was 5.22×107 cfu/mL. Azithromycin treatment resulted in a non-significant reduction in sputum neutrophil proportion, CXCL8 levels and bacterial load. The mean severe exacerbation rate was 0.33 per person per 26 weeks in the azithromycin group compared to 0.93 exacerbations per person in the placebo group (incidence rate ratio (95%CI): 0.37 (0.11,1.21), p = 0.062). For participants who underwent chest CT scans, no alterations were observed.\\n\\nCONCLUSIONS: In stable COPD with neutrophilic bronchitis, add-on azithromycin therapy showed a trend to reduced severe exacerbations sputum neutrophils, CXCL8 levels and bacterial load. Future studies with a larger sample size are warranted.\\n\\nTRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12609000259246.", "link"=>"http://www.mendeley.com/research/effect-azithromycin-adults-stable-neutrophilic-copd-double-blind-randomised-placebo-controlled-trial", "reader_count"=>26, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>1, "Librarian"=>1, "Researcher"=>5, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>2, "Student > Postgraduate"=>3, "Other"=>1, "Student > Master"=>3, "Student > Bachelor"=>3, "Lecturer"=>2, "Professor"=>3}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>1, "Librarian"=>1, "Researcher"=>5, "Student > Doctoral Student"=>2, "Student > Ph. D. Student"=>2, "Student > Postgraduate"=>3, "Other"=>1, "Student > Master"=>3, "Student > Bachelor"=>3, "Lecturer"=>2, "Professor"=>3}, "reader_count_by_subject_area"=>{"Biochemistry, Genetics and Molecular Biology"=>1, "Materials Science"=>1, "Medicine and Dentistry"=>18, "Agricultural and Biological Sciences"=>3, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Immunology and Microbiology"=>1, "Economics, Econometrics and Finance"=>1}, "reader_count_by_subdiscipline"=>{"Materials Science"=>{"Materials Science"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>18}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>3}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "reader_count_by_country"=>{"Denmark"=>1, "Brazil"=>1, "United Kingdom"=>1}, "group_count"=>0}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1647874"], "description"=>"<p>Sputum neutrophil proportion, CXCL8 levels and bacterial load before and following add-on azithromycin therapy in those participants with a high bacterial load (>108 cfu/mL) at baseline.</p>", "links"=>[], "tags"=>["airway disease characterised", "azithromycin 250 mg", "12 week treatment period", "Placebo Controlled Trial BackgroundChronic Obstructive Pulmonary Disease", "chest CT scans", "sputum neutrophil proportion", "exacerbations sputum neutrophils", "neutrophil elastase assessment", "neutrophilic bronchitis", "Stable Neutrophilic COPD", "neutrophilic bronchitis.MethodsEligible participants", "CXCL 8 levels", "load", "ACTRN", "ci", "lung function decline", "neutrophilic airway inflammation"], "article_id"=>1149581, "categories"=>["Biological Sciences"], "users"=>["Jodie L. Simpson", "Heather Powell", "Katherine J. Baines", "David Milne", "Harvey O. Coxson", "Philip M. Hansbro", "Peter G. Gibson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0105609.t003", "stats"=>{"downloads"=>1, "page_views"=>16, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sputum_neutrophil_proportion_CXCL8_levels_and_bacterial_load_before_and_following_add_on_azithromycin_therapy_in_those_participants_with_a_high_bacterial_load_gt_108_cfu_mL_at_baseline_/1149581", "title"=>"Sputum neutrophil proportion, CXCL8 levels and bacterial load before and following add-on azithromycin therapy in those participants with a high bacterial load (>108 cfu/mL) at baseline.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-08-22 03:39:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1647873"], "description"=>"<p>BDP equivalent: dose of inhaled corticosteroids is calculated as beclomethasone equivalents where 1 µg of beclomethasone  = 1 µg budesonide  = 0.5 µg fluticasone; CCQ: Clinical COPD Questionnaire; SGRQ: St George Respiratory Questionnaire; mMRC: modified Medical Research Council; cfu: colony-forming units; PI: Internal perimeter.</p>", "links"=>[], "tags"=>["airway disease characterised", "azithromycin 250 mg", "12 week treatment period", "Placebo Controlled Trial BackgroundChronic Obstructive Pulmonary Disease", "chest CT scans", "sputum neutrophil proportion", "exacerbations sputum neutrophils", "neutrophil elastase assessment", "neutrophilic bronchitis", "Stable Neutrophilic COPD", "neutrophilic bronchitis.MethodsEligible participants", "CXCL 8 levels", "load", "ACTRN", "ci", "lung function decline", "neutrophilic airway inflammation"], "article_id"=>1149580, "categories"=>["Biological Sciences"], "users"=>["Jodie L. Simpson", "Heather Powell", "Katherine J. Baines", "David Milne", "Harvey O. Coxson", "Philip M. Hansbro", "Peter G. Gibson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0105609.t001", "stats"=>{"downloads"=>0, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Participant_characteristics_/1149580", "title"=>"Participant characteristics.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-08-22 03:39:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1647870"], "description"=>"<p>Kaplan-Meier curves showing the proportion of participants without a COPD exacerbation versus the days post randomisation visit (p = 0.100).</p>", "links"=>[], "tags"=>["airway disease characterised", "azithromycin 250 mg", "12 week treatment period", "Placebo Controlled Trial BackgroundChronic Obstructive Pulmonary Disease", "chest CT scans", "sputum neutrophil proportion", "exacerbations sputum neutrophils", "neutrophil elastase assessment", "neutrophilic bronchitis", "Stable Neutrophilic COPD", "neutrophilic bronchitis.MethodsEligible participants", "CXCL 8 levels", "load", "ACTRN", "ci", "lung function decline", "neutrophilic airway inflammation"], "article_id"=>1149577, "categories"=>["Biological Sciences"], "users"=>["Jodie L. Simpson", "Heather Powell", "Katherine J. Baines", "David Milne", "Harvey O. Coxson", "Philip M. Hansbro", "Peter G. Gibson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0105609.g003", "stats"=>{"downloads"=>1, "page_views"=>18, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kaplan_Meier_curves_showing_the_proportion_of_participants_without_a_COPD_exacerbation_versus_the_days_post_randomisation_visit_p_8202_8202_0_100_/1149577", "title"=>"Kaplan-Meier curves showing the proportion of participants without a COPD exacerbation versus the days post randomisation visit (p = 0.100).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-08-22 03:39:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1647868"], "description"=>"<p>Bar graphs showing the change in sputum neutrophil%, IL-8 ng/mL and total bacterial load following treatment with azithromycin (AZM) or placebo.</p>", "links"=>[], "tags"=>["airway disease characterised", "azithromycin 250 mg", "12 week treatment period", "Placebo Controlled Trial BackgroundChronic Obstructive Pulmonary Disease", "chest CT scans", "sputum neutrophil proportion", "exacerbations sputum neutrophils", "neutrophil elastase assessment", "neutrophilic bronchitis", "Stable Neutrophilic COPD", "neutrophilic bronchitis.MethodsEligible participants", "CXCL 8 levels", "load", "ACTRN", "ci", "lung function decline", "neutrophilic airway inflammation"], "article_id"=>1149575, "categories"=>["Biological Sciences"], "users"=>["Jodie L. Simpson", "Heather Powell", "Katherine J. Baines", "David Milne", "Harvey O. Coxson", "Philip M. Hansbro", "Peter G. Gibson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0105609.g002", "stats"=>{"downloads"=>1, "page_views"=>37, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Bar_graphs_showing_the_change_in_sputum_neutrophil_IL_8_ng_mL_and_total_bacterial_load_following_treatment_with_azithromycin_AZM_or_placebo_/1149575", "title"=>"Bar graphs showing the change in sputum neutrophil%, IL-8 ng/mL and total bacterial load following treatment with azithromycin (AZM) or placebo.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-08-22 03:39:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1647867"], "description"=>"<p>Participant consort diagram.</p>", "links"=>[], "tags"=>["airway disease characterised", "azithromycin 250 mg", "12 week treatment period", "Placebo Controlled Trial BackgroundChronic Obstructive Pulmonary Disease", "chest CT scans", "sputum neutrophil proportion", "exacerbations sputum neutrophils", "neutrophil elastase assessment", "neutrophilic bronchitis", "Stable Neutrophilic COPD", "neutrophilic bronchitis.MethodsEligible participants", "CXCL 8 levels", "load", "ACTRN", "ci", "lung function decline", "neutrophilic airway inflammation"], "article_id"=>1149574, "categories"=>["Biological Sciences"], "users"=>["Jodie L. Simpson", "Heather Powell", "Katherine J. Baines", "David Milne", "Harvey O. Coxson", "Philip M. Hansbro", "Peter G. Gibson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0105609.g001", "stats"=>{"downloads"=>0, "page_views"=>19, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Participant_consort_diagram_/1149574", "title"=>"Participant consort diagram.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-08-22 03:39:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1647883", "https://ndownloader.figshare.com/files/1647884"], "description"=>"<div><p>Background</p><p>Chronic Obstructive Pulmonary Disease (COPD) is a progressive airway disease characterised by neutrophilic airway inflammation or bronchitis. Neutrophilic bronchitis is associated with both bacterial colonisation and lung function decline and is common in exacerbations of COPD. Despite current available therapies to control inflammation, neutrophilic bronchitis remains common. This study tested the hypothesis that azithromycin treatment, as an add-on to standard medication, would significantly reduce airway neutrophil and neutrophils chemokine (CXCL8) levels, as well as bacterial load. We conducted a randomised, double-blind, placebo-controlled study in COPD participants with stable neutrophilic bronchitis.</p><p>Methods</p><p>Eligible participants (n = 30) were randomised to azithromycin 250 mg daily or placebo for 12 weeks in addition to their standard respiratory medications. Sputum was induced at screening, randomisation and monthly for a 12 week treatment period and processed for differential cell counts, CXCL8 and neutrophil elastase assessment. Quantitative bacteriology was assessed in sputum samples at randomisation and the end of treatment visit. Severe exacerbations where symptoms increased requiring unscheduled treatment were recorded during the 12 week treatment period and for 14 weeks following treatment. A sub-group of participants underwent chest computed tomography scans (n = 15).</p><p>Results</p><p>Nine participants with neutrophilic bronchitis had a potentially pathogenic bacteria isolated and the median total bacterial load of all participants was 5.22×10<sup>7</sup> cfu/mL. Azithromycin treatment resulted in a non-significant reduction in sputum neutrophil proportion, CXCL8 levels and bacterial load. The mean severe exacerbation rate was 0.33 per person per 26 weeks in the azithromycin group compared to 0.93 exacerbations per person in the placebo group (incidence rate ratio (95%CI): 0.37 (0.11,1.21), p = 0.062). For participants who underwent chest CT scans, no alterations were observed.</p><p>Conclusions</p><p>In stable COPD with neutrophilic bronchitis, add-on azithromycin therapy showed a trend to reduced severe exacerbations sputum neutrophils, CXCL8 levels and bacterial load. Future studies with a larger sample size are warranted.</p><p>Trial Registration</p><p>Australian New Zealand Clinical Trials Registry <a href=\"https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=83551\" target=\"_blank\">ACTRN12609000259246</a></p></div>", "links"=>[], "tags"=>["airway disease characterised", "azithromycin 250 mg", "12 week treatment period", "Placebo Controlled Trial BackgroundChronic Obstructive Pulmonary Disease", "chest CT scans", "sputum neutrophil proportion", "exacerbations sputum neutrophils", "neutrophil elastase assessment", "neutrophilic bronchitis", "Stable Neutrophilic COPD", "neutrophilic bronchitis.MethodsEligible participants", "CXCL 8 levels", "load", "ACTRN", "ci", "lung function decline", "neutrophilic airway inflammation"], "article_id"=>1149584, "categories"=>["Biological Sciences"], "users"=>["Jodie L. Simpson", "Heather Powell", "Katherine J. Baines", "David Milne", "Harvey O. Coxson", "Philip M. Hansbro", "Peter G. Gibson"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0105609.s001", "https://dx.doi.org/10.1371/journal.pone.0105609.s002"], "stats"=>{"downloads"=>21, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_The_Effect_of_Azithromycin_in_Adults_with_Stable_Neutrophilic_COPD_A_Double_Blind_Randomised_Placebo_Controlled_Trial_/1149584", "title"=>"The Effect of Azithromycin in Adults with Stable Neutrophilic COPD: A Double Blind Randomised, Placebo Controlled Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-08-22 03:39:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1647875"], "description"=>"¥<p>GLMM: Generalised Linear Mixed Model;</p>#<p>ANCOVA: adjusted for baseline and robust option for non-parametric data; CCQ: Clinical COPD Questionnaire; SGRQ: St George Respiratory Questionnaire; mMRC: modified Medical Research Council; VAS: visual analogue scale; cfu: colony-forming units; PI: Internal perimeter.</p>", "links"=>[], "tags"=>["airway disease characterised", "azithromycin 250 mg", "12 week treatment period", "Placebo Controlled Trial BackgroundChronic Obstructive Pulmonary Disease", "chest CT scans", "sputum neutrophil proportion", "exacerbations sputum neutrophils", "neutrophil elastase assessment", "neutrophilic bronchitis", "Stable Neutrophilic COPD", "neutrophilic bronchitis.MethodsEligible participants", "CXCL 8 levels", "load", "ACTRN", "ci", "lung function decline", "neutrophilic airway inflammation"], "article_id"=>1149582, "categories"=>["Biological Sciences"], "users"=>["Jodie L. Simpson", "Heather Powell", "Katherine J. Baines", "David Milne", "Harvey O. Coxson", "Philip M. Hansbro", "Peter G. Gibson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0105609.t002", "stats"=>{"downloads"=>1, "page_views"=>18, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_End_of_treatment_clinical_and_inflammatory_outcomes_/1149582", "title"=>"End of treatment clinical and inflammatory outcomes.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-08-22 03:39:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1647872"], "description"=>"<p>n (%), Fisher's exact test.</p>", "links"=>[], "tags"=>["airway disease characterised", "azithromycin 250 mg", "12 week treatment period", "Placebo Controlled Trial BackgroundChronic Obstructive Pulmonary Disease", "chest CT scans", "sputum neutrophil proportion", "exacerbations sputum neutrophils", "neutrophil elastase assessment", "neutrophilic bronchitis", "Stable Neutrophilic COPD", "neutrophilic bronchitis.MethodsEligible participants", "CXCL 8 levels", "load", "ACTRN", "ci", "lung function decline", "neutrophilic airway inflammation"], "article_id"=>1149579, "categories"=>["Biological Sciences"], "users"=>["Jodie L. Simpson", "Heather Powell", "Katherine J. Baines", "David Milne", "Harvey O. Coxson", "Philip M. Hansbro", "Peter G. Gibson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0105609.t004", "stats"=>{"downloads"=>1, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Adverse_events_during_treatment_/1149579", "title"=>"Adverse events during treatment.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-08-22 03:39:08"}

PMC Usage Stats | Further Information

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Relative Metric

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