Evidence map›Paper›PMID 23018904›Full record

Trial reportThe European respiratory journal2013

Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study.

Robert Wilson, Tobias Welte, Eva Polverino, Anthony De Soyza, Hugh Greville, Anne O'Donnell, Jeff Alder, Peter Reimnitz, Barbara Hampel

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The European respiratory journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00930982 (Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis), which is not on this map. Cited by 65 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 13 pooled it
17.3field-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.

NCT00930982 phase2completednot on this map

Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis

TypeinterventionalSponsorBayerRan2009 to 2010Enrolled124ConditionsBronchiectasisArmsCiprofloxacin (Cipro, BAYQ3939), Placebo
3 · Its place in the literature

Who cites it

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

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. 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
  5. Continuous versus intermittent antibiotics for bronchiectasis.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Oral versus inhaled antibiotics for bronchiectasis.The Cochrane database of systematic reviews · 2018
    Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Inhaled colistin in patients with bronchiectasis and chronic Pseudomonas aeruginosa infection.American journal of respiratory and critical care medicine · 2014
    Trial
  15. Trial
  16. Trial
  17. Review
  18. Article
  19. Review
  20. Targeting neutrophil serine proteases in bronchiectasis.The European respiratory journal · 2025
    Review

5 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

9 authors at 8 institutions in 5 countries.

Robert WilsonHost Defence Unit, Royal Brompton Hospital, London, UK. r.wilson@rbht.nhs.uk
Tobias Welte
Eva Polverino
Anthony De Soyza
Hugh Greville
Anne O'Donnell
Jeff Alder
Peter Reimnitz
Barbara Hampel
Bayer (Germany) · DEBayer (United States) · USConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESGeorgetown University · USMedizinische Hochschule Hannover · DENewcastle University · GBRoyal Adelaide Hospital · AURoyal Brompton Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase II, randomised, double-blind, multicentre study (NCT00930982) investigated the safety and efficacy of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis. Adults who were culture positive for pre-defined potential respiratory pathogens (including Pseudomonas aeruginosa and Haemophilus influenzae) were randomised to ciprofloxacin DPI 32.5 mg or placebo administered twice daily for 28 days (with 56 days of follow-up). Bacterial density in sputum (primary end-point), pulmonary function tests, health-related quality of life and safety were monitored throughout the study. 60 subjects received ciprofloxacin DPI 32.5 mg and 64 received placebo. Subjects on ciprofloxacin DPI had a significant reduction (p<0.001) in total sputum bacterial load at the end of treatment (-3.62 log10 CFU·g(-1) (range -9.78-5.02 log10 CFU·g(-1))) compared with placebo (-0.27 log10 CFU·g(-1) (range -7.96-5.25 log10 CFU·g(-1))); the counts increased thereafter. In the ciprofloxacin DPI group, 14 (35%) out of 40 subjects reported pathogen eradication at end of treatment versus four (8%) out of 49 in the placebo group (p=0.001). No abnormal safety results were reported and rates of bronchospasm were low. Ciprofloxacin DPI 32.5 mg twice daily for 28 days was well tolerated and achieved significant reductions in total bacterial load compared with placebo in subjects with non-cystic fibrosis bronchiectasis.

Indexed as

Dry Powder InhalersAdministration, InhalationAgedAnti-Bacterial AgentsBacterial LoadBronchiectasisCiprofloxacinColony Count, MicrobialDouble-Blind MethodDrug Administration ScheduleFemaleHumansInflammationLung DiseasesMaleMiddle AgedAnti-Bacterial AgentsCiprofloxacinPowdersAntibioticbacteriachronic lung infectionexacerbationinflammationPseudomonas aeruginosa

Identifiers

PMID23018904
PMCPMC3640146
OpenAlexW2163025649

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.