Evidence map›Paper›PMID 11867823›Full record

Trial reportThorax2002

Effect of long term treatment with azithromycin on disease parameters in cystic fibrosis: a randomised trial.

J Wolter, S Seeney, S Bell, S Bowler, P Masel, J McCormack

Registry-linked trialOpen access · bronzeAbstract readClinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Thorax, 2002. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00411736 (Supplementary Oral Azithromycin in Treatment of Intermittent Pseudomonas Aeruginosa Colonization in CF-patients With Inhaled Colistin and Oral Ciprofloxacin; Postponing Next Isolate of Pseudomonas and Prevention of Chronic Infection. A Prospective, Double-blinded, Placebo-controlled Scandinavian Multi-centre Study.), which is not on this map. Cited by 129 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
129citing papers in PubMed, 6 pooled it
32.0field-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.

NCT00411736 phase4completednot on this mapstarted 2008, after this paper: background citation

Supplementary Oral Azithromycin in Treatment of Intermittent Pseudomonas Aeruginosa Colonization in CF-patients With Inhaled Colistin and Oral Ciprofloxacin; Postponing Next Isolate of Pseudomonas and Prevention of Chronic Infection. A Prospective, Double-blinded, Placebo-controlled Scandinavian Multi-centre Study.

TypeinterventionalSponsorRigshospitalet, DenmarkRan2008 to 2014Enrolled45ConditionsCystic FibrosisArmsStudy medication, azithromycin or placebo, Azithromycin or placebo tablets
3 · Its place in the literature

Who cites it

129 citing papers in PubMed, 6 syntheses or guidelines pooled it, 513 citations in OpenAlex.

  1. Macrolide antibiotics (including azithromycin) for cystic fibrosis.The Cochrane database of systematic reviews · 2024
    Pooled it
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  4. Oral anti-pseudomonal antibiotics for cystic fibrosis.The Cochrane database of systematic reviews · 2016
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  6. Macrolide antibiotics for cystic fibrosis.The Cochrane database of systematic reviews · 2012
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69 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

J WolterUniversity Department of Medicine and Department of Infectious Disease, Mater Adult Hospital, Brisbane, Australia.
S Seeney
S Bell
S Bowler
P Masel
J McCormack
Mater Adult Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRelentless chronic pulmonary inflammation is the major contributor to morbidity and mortality in patients with cystic fibrosis (CF). While immunomodulating therapies such as prednisolone and ibuprofen may be beneficial, their use is limited by side effects. Macrolides have immunomodulatory properties and long term use dramatically improves prognosis in diffuse panbronchiolitis, a condition with features in common with the lung disease of CF.

methodsTo determine if azithromycin (AZM) improves clinical parameters and reduces inflammation in patients with CF, a 3 month prospective randomised double blind, placebo controlled study of AZM (250 mg/day) was undertaken in adults with CF. Monthly assessment included lung function, weight, and quality of life (QOL). Blood and sputum collection assessed systemic inflammation and changes in bacterial flora. Respiratory exacerbations were treated according to the policy of the CF Unit.

resultsSixty patients were recruited (29 men) of mean (SD) age 27.9 (6.5) years and initial forced expiratory volume in 1 second (FEV1) 56.6 (22.3)% predicted. FEV1% and forced vital capacity (FVC)% predicted were maintained in the AZM group while in the placebo group there was a mean (SE) decline of -3.62 (1.78)% (p=0.047) and -5.73 (1.66)% (p=0.001), respectively. Fewer courses of intravenous antibiotics were used in patients on AZM (0.37 v 1.13, p=0.016). Median C reactive protein (CRP) levels declined in the AZM group from 10 to 5.4 mg/ml but remained constant in the placebo group (p<0.001). QOL improved over time in patients on AZM and remained unchanged in those on placebo (p=0.035).

conclusionAZM in adults with CF significantly improved QOL, reduced CRP levels and the number of respiratory exacerbations, and reduced the rate of decline in lung function. Long term AZM may have a significant impact on morbidity and mortality in patients with CF. Further studies are required to define frequency of dosing and duration of benefit.

Indexed as

AdolescentAdultAnti-Bacterial AgentsAzithromycinCystic FibrosisFemaleHumansLong-Term CareMalePneumonia, BacterialProspective StudiesQuality of LifeSputumTreatment OutcomeAnti-Bacterial AgentsAzithromycin

Identifiers

PMID11867823
PMCPMC1746273
OpenAlexW2123178771

What OpenQuestion holds

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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.