Ciprofloxacin Dry Powder for Inhalation in Patients with Non-Cystic Fibrosis Bronchiectasis or Chronic Obstructive Pulmonary Disease, and in Healthy Volunteers

Staß, Heino; Nagelschmitz, Johannes; Kappeler, Dominik; Sommerer, Knut; Kietzig, Claudius; Weimann, Boris

doi:10.1089/jamp.2015.1282

Cited by 23 publications

(15 citation statements)

References 27 publications

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“…Ciprofloxacin has been formulated into a dry powder for inhalation (DPI) [65,66] and a liposomal form [21,67], and because of its adequate tolerability profile and minimal systemic exposure it has been considered for the treatment of patients with chronic pulmonary conditions and P. aeruginosa infection. The DPI form of ciprofloxacin is delivered via a T-326 inhaler and employs the PulmoShere ® technology, which uses an emulsion-based spray-drying process to produce highly dispersible low density particles [68].…”

Section: Cystic Fibrosismentioning

confidence: 99%

Inhaled Antibiotic Therapy in Chronic Respiratory Diseases

Maselli

Keyt

Restrepo

2017

IJMS

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The management of patients with chronic respiratory diseases affected by difficult to treat infections has become a challenge in clinical practice. Conditions such as cystic fibrosis (CF) and non-CF bronchiectasis require extensive treatment strategies to deal with multidrug resistant pathogens that include Pseudomonas aeruginosa, Methicillin-resistant Staphylococcus aureus, Burkholderia species and non-tuberculous Mycobacteria (NTM). These challenges prompted scientists to deliver antimicrobial agents through the pulmonary system by using inhaled, aerosolized or nebulized antibiotics. Subsequent research advances focused on the development of antibiotic agents able to achieve high tissue concentrations capable of reducing the bacterial load of difficult-to-treat organisms in hosts with chronic respiratory conditions. In this review, we focus on the evidence regarding the use of antibiotic therapies administered through the respiratory system via inhalation, nebulization or aerosolization, specifically in patients with chronic respiratory diseases that include CF, non-CF bronchiectasis and NTM. However, further research is required to address the potential benefits, mechanisms of action and applications of inhaled antibiotics for the management of difficult-to-treat infections in patients with chronic respiratory diseases.

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Section: Cystic Fibrosismentioning

confidence: 99%

Inhaled Antibiotic Therapy in Chronic Respiratory Diseases

Maselli

Keyt

Restrepo

2017

IJMS

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“…It is an antibiotic drug-device combination comprising ciprofloxacin inhalation powder, formulated using PulmoSphere technology (Novartis, San Carlos, CA, USA) [6], and a breath-actuated pocket-sized inhaler (supplementary figure S1). Ciprofloxacin DPI achieves high and reproducible levels of drug deposition across ventilated lung areas in patients with NCFB [7]. The 28-day cyclical regimen has traditionally been used in cystic fibrosis (CF) with the intention of maximising treatment effects while minimising resistance, but the appropriateness of this treatment strategy for NCFB is unknown.…”

Section: Introductionmentioning

confidence: 99%

RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis

et al. 2018

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We evaluated the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis, two or more exacerbations in the previous year and pre-defined bacteria in sputum.In this phase III, double-blind, placebo-controlled trial, patients were randomised 2:1 to twice-daily ciprofloxacin DPI 32.5 mg or placebo in two treatment regimens consisting of on/off treatment cycles of 14 or 28 days for 48 weeks. The primary end-points were time to first exacerbation and frequency of exacerbations.A total of 416 patients were randomised to the 14-day on/off regimen (ciprofloxacin DPI (n=137) and placebo (n=68)) or the 28-day on/off regimen (ciprofloxacin DPI (n=141) and placebo (n=70)). Ciprofloxacin DPI 14 days on/off significantly prolonged time to first exacerbation pooled placebo (median time>336 186 days; hazard ratio 0.53, 97.5% CI 0.36-0.80; p=0.0005) and reduced the frequency of exacerbations compared with matching placebo by 39% (mean number of exacerbations 0.6 1.0; incidence rate ratio 0.61, 97.5% CI 0.40-0.91; p=0.0061). Outcomes for ciprofloxacin DPI 28 days on/off were not statistically significantly different from placebo. The safety profile of ciprofloxacin DPI was favourable.Ciprofloxacin DPI was well tolerated and has the potential to be an effective treatment option in non-cystic fibrosis bronchiectasis.

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“…The TLD observed with CIP was comparable for healthy volunteers and for patients with chronic obstructive pulmonary disease (COPD) or BE, although a more central lung deposition was observed in COPD and BE patients [38]. Drug delivery to the lungs with CIP is largely [49].…”

Section: Aerosol Deliverymentioning

confidence: 95%

“…Two formulation strategies have been advanced in clinical development for sustaining levels of ciprofloxacin in the lungs: a dispersion of the drug encapsulated in liposomes [18,20,21,[27][28][29][30][31][32], and a dry powder formulation comprising the poorly soluble betaine form of the drug substance [17,[33][34][35][36][37][38][39][40][41]. A detailed comparison of the two formulations is presented in Table 1, with electron microscopy images of the two types of particles presented in Fig.…”

Section: Phospholipid-based Delivery Systemsmentioning

confidence: 99%

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Comparison of Phospholipid-Based Particles for Sustained Release of Ciprofloxacin Following Pulmonary Administration to Bronchiectasis Patients

Weers¹

2019

Pulm Ther

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The rapid clearance of ciprofloxacin hydrochloride from the lungs following administration as an aerosol leads to poor efficacy in the treatment of pulmonary infections. The development of formulations capable of sustaining ciprofloxacin concentrations in the lungs has the potential to significantly improve antibacterial activity. The present review compares two approaches for sustaining levels of ciprofloxacin in the lungs, a liposomal formulation where ciprofloxacin is encapsulated in small unilamellar vesicles, and a dry powder formulation of the practically insoluble zwitterionic form of the drug. These two formulations recently completed large multicenter, phase 3 clinical studies in bronchiectasis patients. As such, they present a unique opportunity to examine the chemistry, manufacturing, and control of the dosage forms in addition to their tolerability and efficacy in more than 1000 bronchiectasis patients. Both formulations were generally well tolerated with most adverse events found to be mild to moderate in intensity. While the formulations were effective in reducing and/or eradicating infections, this did not lead to reductions in pulmonary exacerbations, the primary endpoint. The failures speak more to the heterogeneous nature of the disease and the difficulty in identifying bronchiectasis patients likely to exacerbate, rather than an inherent limitation of the formulations. While the formulations are similar in many respects, they also present some interesting differences. This review explores the implications of these differences on the treatment of respiratory infections.

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Ciprofloxacin Dry Powder for Inhalation in Patients with Non-Cystic Fibrosis Bronchiectasis or Chronic Obstructive Pulmonary Disease, and in Healthy Volunteers

Abstract: This study supports the continued development of Ciprofloxacin DPI in NCFB patients with respiratory bacterial pathogens.

Cited by 23 publications

References 27 publications

Inhaled Antibiotic Therapy in Chronic Respiratory Diseases

Inhaled Antibiotic Therapy in Chronic Respiratory Diseases

RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis

Comparison of Phospholipid-Based Particles for Sustained Release of Ciprofloxacin Following Pulmonary Administration to Bronchiectasis Patients

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