Ciprofloxacin DPI in non-cystic fibrosis bronchiectasis: a Phase II randomized study

Antoniu, Sabina A; Azoicăi, Doina

doi:10.1517/13543784.2013.783565

Cited by 13 publications

(10 citation statements)

References 5 publications

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“…After screening the titles and abstracts, we retrieved 17 potentially relevant full-text articles for further evaluation. Nine articles [6,[12][13][14][15][16][17][18][19] were excluded for reasons shown in figure 1. The findings of one trial were reported by BARKER et al [9] in 2000 and by COUCH [20] in 2001, so this trial was labelled as BARKER 2000 and COUCH 2001.…”

Section: Search Results and Study Selectionmentioning

confidence: 99%

Inhaled antibiotics for stable non-cystic fibrosis bronchiectasis: a systematic review

2014

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We conducted a meta-analysis of randomised trials to evaluate the efficacy and safety of inhaled antibiotics in patients with stable non-cystic fibrosis (CF) bronchiectasis.We searched the Cochrane Airways Group Register of Trials from inception until March 2014. 12 trials with 1264 adult patients were included, of which five were unpublished studies. Eight trials on 590 patients contributed data to the meta-analysis. Amikacin, aztreonam, ciprofloxacin, gentamicin, colistin or tobramycin were used for 4 weeks to 12 months. Inhaled antibiotics were more effective than placebo or symptomatic treatment in reducing sputum bacterial load (five trials; weighted mean difference -2.65 log 10 CFU?g -1 , 95% CI -4.38--0.92 log 10 CFU?g -1 ), eradicating the bacteria from sputum (six trials; risk ratio 4.2, 95% CI 1.66-10.64) and reducing the risk of acute exacerbations (five trials; risk ratio 0.72, 95% CI 0.55-0.94). Bronchospasm occurred in 10% of patients treated with inhaled antibiotics compared with 2.3% in the control group (seven trials; risk ratio 2.96, 95% CI 1.30-6.73), but the two groups had the same withdrawal rate due to adverse events (12.2%).Inhaled antibiotics may provide an effective suppressive antibiotic therapy with an acceptable safety profile in adult patients with stable non-CF bronchiectasis and chronic bronchial infection. @ERSpublications Inhaled antibiotics are effective with an acceptable safety profile in adults with stable non-CF bronchiectasis

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Section: Search Results and Study Selectionmentioning

confidence: 99%

Inhaled antibiotics for stable non-cystic fibrosis bronchiectasis: a systematic review

2014

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“…The most consistent finding has been a reduction of bacterial density, usually P. aeruginosa with eradication described in 30–35% (and eradication up to 93% of other Gram‐negative bacteria) . Reduction in myeloperoxidase, free elastase and CRP has been reported but not consistently and such reductions were not related to clinical improvements.…”

Section: Long‐term Treatments Of Bronchiectasismentioning

confidence: 97%

“…82 The SGRQ improved in four of the six studies 18,81,82,84 and the Quality of Life-Bronchiectasis (QOLB) questionnaire 105 improved in one aztreonam study. 18,81 The most consistent finding has been a reduction of bacterial density, usually P. aeruginosa 20,[82][83][84]104 with eradication described in 30-35% (and eradication up to 93% of other Gram-negative bacteria). 18,80,82,84 Reduction in myeloperoxidase, free elastase 82 and CRP 84,104 has been reported but not consistently 19 and such reductions were not related to clinical improvements.…”

Section: Should Long-term or Rotational Antibiotics Be Used?mentioning

confidence: 97%

“…100,101 To date, none have been approved or registered for the treatment of patients with bronchiectasis. 86 A number of randomized placebo-controlled trials investigating tobramycin, 19,80,102 gentamicin, 82 colistin, 20 aztreonam 81 and ciprofloxacin 18,83,84,103,104 have been undertaken ( Table 2). The majority involved older adults (mean age of these studies ranges from 57 to 69 years) who had chronic P. aeruginosa infection and advanced pulmonary disease.…”

Section: Should Long-term or Rotational Antibiotics Be Used?mentioning

confidence: 99%

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Bronchiectasis: Treatment decisions for pulmonary exacerbations and their prevention

2018

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Interest in bronchiectasis has increased over the past two decades, as shown by the establishment of disease-specific registries in several countries, the publication of management guidelines and a growing number of clinical trials to address evidence gaps for treatment decisions. This review considers the evidence for defining and treating pulmonary exacerbations, the approaches for eradication of newly identified airway pathogens and the methods to prevent exacerbations through long-term treatments from a pragmatic practice-based perspective. Areas for future studies are also explored. Watch the video abstract.

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“…Systemic exposure was slightly higher with the 48.75 mg dose; however, the peak sputum concentrations and area under the concentration-time curve (AUC) values were similar with the two doses, which led the authors to recommend advancing the lower dose into later-phase trials. The same DPI formulation of ciprofloxacin is also being evaluated in patients with noncystic fibrosis bronchiectasis [80,81]. Limited pharmacokinetic data have been published; however, preliminary efficacy studies have demonstrated that a dose of 32.5 mg twice daily for 28 days was well tolerated and reduced the sputum bacterial load in comparison with placebo-treated subjects [81].…”

Section: Ciprofloxacinmentioning

confidence: 99%

Clinical Pharmacokinetics of Inhaled Antimicrobials

2015

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Administration of inhaled antimicrobials affords the ability to achieve targeted drug delivery into the respiratory tract, rapid entry into the systemic circulation, high bioavailability and minimal metabolism. These unique pharmacokinetic characteristics make inhaled antimicrobial delivery attractive for the treatment of many pulmonary diseases. This review examines recent pharmacokinetic trials with inhaled antibacterials, antivirals and antifungals, with an emphasis on the clinical implications of these studies. The majority of these studies revealed evidence of high antimicrobial concentrations in the airway with limited systemic exposure, thereby reducing the risk of toxicity. Sputum pharmacokinetics varied widely, which makes it challenging to interpret the result of sputum pharmacokinetic studies. Many no vel inhaled antimicrobial therapies are currently under investigation that will require detailed pharmacokinetic studies, including combination inhaled antimicrobial therapies, inhaled nanoparticle formulations of several antibacterials, inhaled non-antimicrobial adjuvants, inhaled antiviral recombinant protein therapies and semi-synthetic inhaled antifungal agents. Additionally, the development of new inhaled delivery devices, particularly for mechanically ventilated patients, will result in a pressing need for additional pharmacokinetic studies to identify optimal dosing regimens.

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Ciprofloxacin DPI in non-cystic fibrosis bronchiectasis: a Phase II randomized study

Abstract: On short-term basis C-DPI is able to reduce the sputum bacterial load in such patients but long-term studies are also needed to better characterize the clinical efficacy of this compound.

Cited by 13 publications

References 5 publications

Inhaled antibiotics for stable non-cystic fibrosis bronchiectasis: a systematic review

Inhaled antibiotics for stable non-cystic fibrosis bronchiectasis: a systematic review

Bronchiectasis: Treatment decisions for pulmonary exacerbations and their prevention

Clinical Pharmacokinetics of Inhaled Antimicrobials

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