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Use of Artificial Sputum Medium to Test Antibiotic Efficacy Against Pseudomonas aeruginosa in Conditions More Relevant to the Cystic Fibrosis Lung
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Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study

Robert Wilson1, Tobias Welte, Eva Polverino

  • 1Host Defence Unit, Royal Brompton Hospital, London, UK. r.wilson@rbht.nhs.uk

The European Respiratory Journal
|September 29, 2012
PubMed

Insights

Ciprofloxacin dry powder for inhalation (DPI) significantly reduced bacterial load in patients with non-cystic fibrosis bronchiectasis. This treatment was well-tolerated and demonstrated efficacy in pathogen eradication.

Area of Science:

  • Respiratory Medicine
  • Infectious Diseases
  • Clinical Pharmacology

Background:

  • Non-cystic fibrosis bronchiectasis is a chronic lung disease characterized by airway damage and recurrent infections.
  • Management of bronchiectasis often involves addressing bacterial infections, which can exacerbate lung function decline.
  • Limited effective inhaled antibiotic options exist for managing chronic respiratory pathogens in this population.

Purpose of the Study:

  • To evaluate the safety and efficacy of ciprofloxacin dry powder for inhalation (DPI) in adults with non-cystic fibrosis bronchiectasis.
  • To assess the impact of ciprofloxacin DPI on bacterial load in sputum and pathogen eradication.
  • To monitor pulmonary function, quality of life, and safety parameters during treatment.

Main Methods:

  • A phase II, randomized, double-blind, multicenter study (NCT00930982) involving adults with culture-positive non-cystic fibrosis bronchiectasis.
  • Participants received ciprofloxacin DPI 32.5 mg or placebo twice daily for 28 days, followed by 56 days of follow-up.
  • Primary endpoint was the reduction in sputum bacterial density; secondary endpoints included pulmonary function, quality of life, and safety.

Main Results:

  • Ciprofloxacin DPI significantly reduced total sputum bacterial load compared to placebo (p<0.001).
  • Pathogen eradication was achieved in 35% of subjects receiving ciprofloxacin DPI versus 8% receiving placebo (p=0.001).
  • The treatment was well-tolerated, with low rates of bronchospasm and no abnormal safety findings.

Conclusions:

  • Ciprofloxacin DPI 32.5 mg twice daily for 28 days is a safe and effective treatment for reducing bacterial load in non-cystic fibrosis bronchiectasis.
  • Inhaled ciprofloxacin demonstrates potential for pathogen eradication in this patient population.
  • Further investigation into inhaled antibiotics for non-cystic fibrosis bronchiectasis is warranted.
Keywords:
AntibioticPseudomonas aeruginosabacteriachronic lung infectionexacerbationinflammation

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