Evidence map›Paper›PMID 21864166›Full record

Trial reportThe New England journal of medicine2011

Azithromycin for prevention of exacerbations of COPD.

Richard K Albert, John Connett, William C Bailey, Richard Casaburi, J Allen D Cooper, Gerard J Criner, Jeffrey L Curtis, Mark T Dransfield, Meilan K Han, Stephen C Lazarus and 16 more

Erratum issued 3 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 482 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
482citing papers in PubMed, 13 pooled it
84.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00325897 nacompletednot on this map

Effect of Chronic Macrolide Administration on the Frequency and Severity of COPD Exacerbations

TypeinterventionalSponsorUniversity of MinnesotaRan2006 to 2010Enrolled1,142ConditionsPulmonary Disease, Chronic ObstructiveArmsMacrolide Antibiotic (Azithromycin), Placebo
NCT02690038 phase2completednot on this mapstarted 2016, after this paper: background citation

Feasibility and Safety of Immunoglobulin (Ig) Prophylactic Treatment in COPD Patients With Frequent Exacerbations: A Pilot Study

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2016 to 2019Enrolled48ConditionsChronic Obstructive Pulmonary DiseaseArmsIntravenous immunoglobulin (IVIG), Normal Saline
NCT05764993 phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

Prevalence of Humoral Immune Deficiency in Patients With Frequent Exacerbations of COPD, and the Effect of Immunoglobulin Replacement on Future Exacerbations

TypeinterventionalSponsorRochester General HospitalRan2023 to 2025Enrolled40ConditionsCOPD Exacerbation AcuteArmsCUVITRU - Ig subcutaneous human 20%, Standard Medical Therapy
3 · Its place in the literature

Who cites it

482 citing papers in PubMed, 13 syntheses or guidelines pooled it, 1,200 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Romanian clinical guideline for diagnosis and treatment of COPD.The Journal of international medical research · 2020
    Guideline
  12. Pooled it
  13. The efficacy and safety of azithromycin in asthma: A systematic review.Journal of cellular and molecular medicine · 2019
    Pooled it
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

422 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 1 institution in 1 country.

Richard K AlbertMedicine Service, Denver Health and Department of Medicine, University of Colorado Denver Health Sciences Center, Denver, CO 80204-4507, USA. ralbert@dhha.org
John Connett
William C Bailey
Richard Casaburi
J Allen D Cooper
Gerard J Criner
Jeffrey L Curtis
Mark T Dransfield
Meilan K Han
Stephen C Lazarus
Barry Make
Nathaniel Marchetti
Fernando J Martinez
Nancy E Madinger
Charlene McEvoy
Dennis E Niewoehner
Janos Porsasz
Connie S Price
John Reilly
Paul D Scanlon
Frank C Sciurba
Steven M Scharf
George R Washko
Prescott G Woodruff
Nicholas R Anthonisen
COPD Clinical Research Network
Denver Public Health · US

Funding

ZONA-FREE HAMSTER OVA ASSAY AS AN INDICATOR OF MALE FERTILITYM01RR000425 · NCRR · LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · PI ANDERSON, GAIL V · 1985 to 2011
$74.2M
ZOPOLRESTAT PHARMACOKINETICS IN DIABETICS WITH VARYING RENAL FUNCTIONM01RR000051 · NCRR · UNIVERSITY OF COLORADO DENVER · PI KOSMISKI, LISA A. · 1985 to 2008
$52.6M
Zoledronic Acid in Treatment of Osteoporosis in PostmenoM01RR002635 · NCRR · BRIGHAM AND WOMEN'S HOSPITAL · PI GARBER, JUDY E. · 1985 to 2008
$48.4M
WITHIN SUBJ VARIABILITY IN MEASUREMENTS DRUG METABOL ENZYMES IN HLTY SUBJM01RR000056 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI LEVINE, ARTHUR S · 1985 to 2006
$29.2M
COPD Clinical Research Network - Data Coordinating CenterU10HL074424 · NHLBI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI CONNETT, JOHN E · 2003 to 2011
$21.0M
Zonulin Antibodies in Intestinal Permeabilitiy in IDDMM01RR016500 · NCRR · UNIVERSITY OF MARYLAND BALTIMORE · PI OSWALD, LYNN M · 2002 to 2009
$20.2M
Novel Strategies Targeting Acute Exacerbation of COPDU10HL074409 · NHLBI · DENVER HEALTH AND HOSPITAL AUTHORITY · PI ALBERT, RICHARD K · 2003 to 2007
$4.1M
COPD Exacerbations: Pharmacogenetic Approaches to TherapyU10HL074428 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI WASHKO, GEORGE R · 2003 to 2007
$3.4M
UAB/BVAMC Clinical Center in COPDU10HL074418 · NHLBI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI DRANSFIELD, MARK T · 2003 to 2007
$3.3M
Strategies to Improve COPD ManagementU10HL074407 · NHLBI · LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · PI CASABURI, RICHARD · 2003 to 2007
$3.2M
COPD Clinical Research Network & Clinical Research Skills Core DevelopmentU10HL074408 · NHLBI · TEMPLE UNIV OF THE COMMONWEALTH · PI CRINER, GERARD J · 2004 to 2007
$2.7M
Drug therapy for preventing COPD exacerbationsU10HL074416 · NHLBI · MINNESOTA VETERANS RESEARCH INST · PI NIEWOEHNER, DENNIS E. · 2003 to 2007
$2.7M
NCRR NIH HHS M01 RR00051NCRR NIH HHS M01 RR00056NCRR NIH HHS M01 RR00425NCRR NIH HHS M01 RR02635NCRR NIH HHS M01 RR16500NHLBI NIH HHS 1U10-HL074416NHLBI NIH HHS 1U10- HL074424NHLBI NIH HHS 1U10-HL074431NHLBI NIH HHS HL074407NHLBI NIH HHS HL074408NHLBI NIH HHS HL074409NHLBI NIH HHS HL074418NHLBI NIH HHS HL074422NHLBI NIH HHS HL074428NHLBI NIH HHS HL074439NHLBI NIH HHS HL074441NHLBI NIH HHS K23 HL089353NHLBI NIH HHS U10 HL074407NHLBI NIH HHS U10 HL074408NHLBI NIH HHS U10 HL074409NHLBI NIH HHS U10 HL074416NHLBI NIH HHS U10 HL074418NHLBI NIH HHS U10 HL074422NHLBI NIH HHS U10 HL074424NHLBI NIH HHS U10 HL074428NHLBI NIH HHS U10 HL074431NHLBI NIH HHS U10 HL074439NHLBI NIH HHS U10 HL074441
6 · The paper itself

Abstract

backgroundAcute exacerbations adversely affect patients with chronic obstructive pulmonary disease (COPD). Macrolide antibiotics benefit patients with a variety of inflammatory airway diseases.

methodsWe performed a randomized trial to determine whether azithromycin decreased the frequency of exacerbations in participants with COPD who had an increased risk of exacerbations but no hearing impairment, resting tachycardia, or apparent risk of prolongation of the corrected QT interval.

resultsA total of 1577 subjects were screened; 1142 (72%) were randomly assigned to receive azithromycin, at a dose of 250 mg daily (570 participants), or placebo (572 participants) for 1 year in addition to their usual care. The rate of 1-year follow-up was 89% in the azithromycin group and 90% in the placebo group. The median time to the first exacerbation was 266 days (95% confidence interval [CI], 227 to 313) among participants receiving azithromycin, as compared with 174 days (95% CI, 143 to 215) among participants receiving placebo (P<0.001). The frequency of exacerbations was 1.48 exacerbations per patient-year in the azithromycin group, as compared with 1.83 per patient-year in the placebo group (P=0.01), and the hazard ratio for having an acute exacerbation of COPD per patient-year in the azithromycin group was 0.73 (95% CI, 0.63 to 0.84; P<0.001). The scores on the St. George's Respiratory Questionnaire (on a scale of 0 to 100, with lower scores indicating better functioning) improved more in the azithromycin group than in the placebo group (a mean [±SD] decrease of 2.8±12.8 vs. 0.6±11.4, P=0.004); the percentage of participants with more than the minimal clinically important difference of -4 units was 43% in the azithromycin group, as compared with 36% in the placebo group (P=0.03). Hearing decrements were more common in the azithromycin group than in the placebo group (25% vs. 20%, P=0.04).

conclusionsAmong selected subjects with COPD, azithromycin taken daily for 1 year, when added to usual treatment, decreased the frequency of exacerbations and improved quality of life but caused hearing decrements in a small percentage of subjects. Although this intervention could change microbial resistance patterns, the effect of this change is not known. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00325897.).

Indexed as

AgedAnti-Bacterial AgentsAzithromycinBacterial InfectionsDrug Resistance, BacterialFemaleHumansMacrolidesMaleMiddle AgedNasopharynxProspective StudiesPulmonary Disease, Chronic ObstructiveTreatment OutcomeAnti-Bacterial AgentsAzithromycinMacrolides

Identifiers

PMID21864166
PMCPMC3220999
OpenAlexW2096373158

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.