Evidence map›Paper›PMID 23681906›Full record

Trial reportThorax2013

Inhaled, dual release liposomal ciprofloxacin in non-cystic fibrosis bronchiectasis (ORBIT-2): a randomised, double-blind, placebo-controlled trial.

David J Serisier, Diana Bilton, Anthony De Soyza, Philip J Thompson, John Kolbe, Hugh W Greville, David Cipolla, Paul Bruinenberg, Igor Gonda, ORBIT-2 investigators

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Thorax, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 11 pooled it
23.2field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 11 syntheses or guidelines pooled it, 244 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Intermittent prophylactic antibiotics for bronchiectasis.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Pooled it
  5. A systematic review of pharmacotherapeutic clinical trial end-points for bronchiectasis in adults.European respiratory review : an official journal of the European Respiratory Society · 2019
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Bronchiectasis.BMJ clinical evidence · 2015
    Pooled it
  10. Pooled it
  11. Pooled it
  12. Inhaled colistin in patients with bronchiectasis and chronic Pseudomonas aeruginosa infection.American journal of respiratory and critical care medicine · 2014
    Trial
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Article

18 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

10 authors at 8 institutions in 4 countries.

David J SerisierDepartment of Respiratory Medicine, Mater Medical Research Institute and University of Queensland, Mater Adult Hospital, South Brisbane, Queensland, Australia. david.serisier@mater.org.au
Diana Bilton
Anthony De Soyza
Philip J Thompson
John Kolbe
Hugh W Greville
David Cipolla
Paul Bruinenberg
Igor Gonda
ORBIT-2 investigators
Aradigm (United States) · USEagle Pharmaceuticals (United States) · USMater Adult Hospital · AUNewcastle University · GBRoyal Adelaide Hospital · AURoyal Brompton Hospital · GBThe University of Western Australia · AUUniversity of Auckland · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe delivery of antipseudomonal antibiotics by inhalation to Pseudomonas aeruginosa-infected subjects with non-cystic fibrosis (CF) bronchiectasis is a logical extension of treatment strategies successfully developed in CF bronchiectasis. Dual release ciprofloxacin for inhalation (DRCFI) contains liposomal ciprofloxacin, formulated to optimise airway antibiotic delivery.

methodsPhase II, 24-week Australian/New Zealand multicentre, randomised, double-blind, placebo-controlled trial in 42 adult bronchiectasis subjects with ≥2 pulmonary exacerbations in the prior 12 months and ciprofloxacin-sensitive P aeruginosa at screening. Subjects received DRCFI or placebo in three treatment cycles of 28 days on/28 days off. The primary outcome was change in sputum P aeruginosa bacterial density to the end of treatment cycle 1 (day 28), analysed by modified intention to treat (mITT). Key secondary outcomes included safety and time to first pulmonary exacerbation-after reaching the pulmonary exacerbation endpoint subjects discontinued study drug although remained in the study.

resultsDRCFI resulted in a mean (SD) 4.2 (3.7) log10 CFU/g reduction in P aeruginosa bacterial density at day 28 (vs -0.08 (3.8) with placebo, p=0.002). DRCFI treatment delayed time to first pulmonary exacerbation (median 134 vs 58 days, p=0.057 mITT, p=0.046 per protocol). DRCFI was well tolerated with a similar incidence of systemic adverse events to the placebo group, but fewer pulmonary adverse events.

conclusionsOnce-daily inhaled DRCFI demonstrated potent antipseudomonal microbiological efficacy in adults with non-CF bronchiectasis and ciprofloxacin-sensitive P aeruginosa. In this modest-sized phase II study, DRCFI was also well tolerated and delayed time to first pulmonary exacerbation in the per protocol population.

Indexed as

Pseudomonas aeruginosaAdministration, InhalationAgedAnti-Bacterial AgentsBronchiectasisCiprofloxacinDelayed-Action PreparationsDisease ProgressionDouble-Blind MethodFemaleHumansKaplan-Meier EstimateLiposomesMaleMiddle AgedPseudomonas InfectionsAnti-Bacterial AgentsCiprofloxacinDelayed-Action PreparationsLiposomesBronchiectasisRespiratory Infection

Identifiers

PMID23681906
PMCPMC4770250
OpenAlexW2161605184

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.