Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials

Haworth, Charles; Bilton, Diana; Chalmers, James D.; Davis, Angela; Froehlich, Juergen; Gonda, Igor; Thompson, Bruce; Wanner, Adam; O’Donnell, Anne E.

doi:10.1016/s2213-2600(18)30427-2

Cited by 159 publications

(167 citation statements)

References 36 publications

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“…Then to evaluate activity, initial safety, and pharmacokinetics of once-daily inhaled ciprofloxacin-loaded liposome (Lipoquin), a Phase 2a multi-center 14-day trial was conducted in 21 adult CF patients. Concurrently, an international, double-blind, randomized, phase 3 trials (ORBIT-3 and ORBIT-4) were run in similar regions to investigate the safety and efficacy of inhaled liposomal ciprofloxacin [208,209]. Moreover, amikacin-loaded liposomes were evaluated in many clinical studies.…”

Section: Antibiotic Agentsmentioning

confidence: 99%

Nanomedicine Fight against Antibacterial Resistance: An Overview of the Recent Pharmaceutical Innovations

et al. 2020

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Based on the recent reports of World Health Organization, increased antibiotic resistance prevalence among bacteria represents the greatest challenge to human health. In addition, the poor solubility, stability, and side effects that lead to inefficiency of the current antibacterial therapy prompted the researchers to explore new innovative strategies to overcome such resilient microbes. Hence, novel antibiotic delivery systems are in high demand. Nanotechnology has attracted considerable interest due to their favored physicochemical properties, drug targeting efficiency, enhanced uptake, and biodistribution. The present review focuses on the recent applications of organic (liposomes, lipid-based nanoparticles, polymeric micelles, and polymeric nanoparticles), and inorganic (silver, silica, magnetic, zinc oxide (ZnO), cobalt, selenium, and cadmium) nanosystems in the domain of antibacterial delivery. We provide a concise description of the characteristics of each system that render it suitable as an antibacterial delivery agent. We also highlight the recent promising innovations used to overcome antibacterial resistance, including the use of lipid polymer nanoparticles, nonlamellar liquid crystalline nanoparticles, anti-microbial oligonucleotides, smart responsive materials, cationic peptides, and natural compounds. We further discuss the applications of antimicrobial photodynamic therapy, combination drug therapy, nano antibiotic strategy, and phage therapy, and their impact on evading antibacterial resistance. Finally, we report on the formulations that made their way towards clinical application.

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Section: Antibiotic Agentsmentioning

confidence: 99%

Nanomedicine Fight against Antibacterial Resistance: An Overview of the Recent Pharmaceutical Innovations

et al. 2020

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“…Indeed, there is a ‘surge of randomized controlled trials (RCT) in bronchiectasis in the last 10 years, increasing from 91 RCT in 2008 to 252 by July 2019’ . For the first time, a pharmaceutical‐initiated large RCT was undertaken in adults with bronchiectasis prior to being tried for cystic fibrosis (CF) . The ORBIT RCT showed efficacy of once‐daily inhaled liposome‐encapsulated/free ciprofloxacin (ARD‐3150) in chronically infected adult patients with Pseudomonas aeruginosa (Pa) in reducing exacerbation frequency and severity compared to placebo .…”

Section: Disclosure Statementmentioning

confidence: 99%

“…For the first time, a pharmaceutical‐initiated large RCT was undertaken in adults with bronchiectasis prior to being tried for cystic fibrosis (CF) . The ORBIT RCT showed efficacy of once‐daily inhaled liposome‐encapsulated/free ciprofloxacin (ARD‐3150) in chronically infected adult patients with Pseudomonas aeruginosa (Pa) in reducing exacerbation frequency and severity compared to placebo . The recent BEST RCT assessed the role of oral antibiotics for treating non‐severe exacerbations of bronchiectasis in children .…”

Section: Disclosure Statementmentioning

confidence: 99%

“…7 The ORBIT RCT showed efficacy of once-daily inhaled liposome-encapsulated/free ciprofloxacin (ARD-3150) in chronically infected adult patients with Pseudomonas aeruginosa (Pa) in reducing exacerbation frequency and severity compared to placebo. 7 The recent BEST RCT assessed the role of oral antibiotics for treating non-severe exacerbations of bronchiectasis in children. 8 BEST-1, the first placebocontrolled RCT for exacerbations, showed the efficacy of amoxicillin-clavulanate and azithromycin over placebo (relative risk of bronchiectasis resolution by day 14 was 1.50 (95% CI: 1.08-2.09; P = 0.015) and 1.41 (95% CI: 1.01-1.97; P = 0.042), respectively).…”

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confidence: 99%

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Twenty‐five years of Respirology: Advances in bronchiectasis

Chotirmall

Chang

2019

Respirology

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“…There are, however, specific aetiologies associated with bronchiectasis that include, but are not limited to, CF, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis (ABPA), alpha‐1‐antitrypsin deficiency, aspiration, immunodeficiency, asthma (non‐ABPA), chronic obstructive pulmonary disease (COPD), rheumatological disease (RD) and inflammatory bowel disease (IBD) . With the exception of CF‐associated bronchiectasis, the heterogeneity of presentations and natural disease courses implicit to bronchiectasis has likely contributed to the observed varied clinical responses to therapeutic interventions, including results from the recent phase III inhaled antibiotic clinical studies that have consistently not met the primary endpoints . The extent to which the various bronchiectatic phenotypes and endotypes respond to specific treatment is essentially unknown and is a matter of intense research interest and investigation.…”

Section: Introductionmentioning

confidence: 99%

Paediatric and adult bronchiectasis: Specific management with coexisting asthma, COPD, rheumatological disease and inflammatory bowel disease

2019

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Bronchiectasis, conventionally defined as irreversible dilatation of the bronchial tree, is generally suspected on a clinical basis and confirmed by means of chest high-resolution computed tomography. Clinical manifestations, including chronic productive cough and endobronchial suppuration with persistent chest infection and inflammation, may deeply affect quality of life, both in children/adolescents and adults. Despite many cases being idiopathic or post-infectious, a number of specific aetiologies have been traditionally associated with bronchiectasis, such as cystic fibrosis (CF), primary ciliary dyskinesia or immunodeficiencies. Nevertheless, bronchiectasis may also develop in patients with bronchial asthma; chronic obstructive pulmonary disease; and, less commonly, rheumatological disorders and inflammatory bowel diseases. Available literature on the development of bronchiectasis in these conditions and on its management is limited, particularly in children. However, bronchiectasis may complicate the clinical course of the underlying condition at any age, and appropriate management requires an integration of multiple skills in a team of complementary experts to provide the most appropriate care to affected children and adolescents. The present review aims at summarizing the current knowledge and available evidence on the management of bronchiectasis in the other conditions mentioned and focuses on the new therapeutic strategies that are emerging as promising tools for improving patients' quality of life.

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Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials

Cited by 159 publications

References 36 publications

Nanomedicine Fight against Antibacterial Resistance: An Overview of the Recent Pharmaceutical Innovations

Nanomedicine Fight against Antibacterial Resistance: An Overview of the Recent Pharmaceutical Innovations

Twenty‐five years of Respirology: Advances in bronchiectasis

Paediatric and adult bronchiectasis: Specific management with coexisting asthma, COPD, rheumatological disease and inflammatory bowel disease

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