Quinsair (levofloxacin inhalational) / Chiesi, Amgen - LARVOL DELTA

Comparison of the Efficacy of Adding Inhaled Levofloxacin and Colistin to a Basic Regimen of Colistin and Meropenem in the Treatment of Ventilator-associated Pneumonia Caused by Multidrug-resistant Gram-negative Bacteria: A Randomized Open-label Clinical Trial. (PubMed, J Res Pharm Pract) - "Levofloxacin inhalation may be considered an effective alternative to colistin inhalation for treating VAP caused by MDR-GNB. It offers similar efficacy and lower nephrotoxicity."

Journal • Acute Kidney Injury • Cough • Critical care • Infectious Disease • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases • CRP

Nocardia wallacei and Aspergillus Fumigatus complex, an exacerbating combination (ECFS 2025) - "Amoxicillin-clavulanic acid (Am-Cl) was started. A slow growth of N. wallacei was reported, so he was treated with oral Trimethoprim-sulfamethoxazole (TMT-SMX) and inhaled levofloxacin for on/off month cycles...One month later, in October 2024, he presented haemoptotic sputum, so an oral course of TMT-SMX and ciprofloxacin for two weeks was started, and the inhaled amikacin was replaced by inhaled ceftazidime in on/off month cycles with inhaled levofloxacin...She did not meet allergic pulmonary aspergillosis criteria, so it was treated with oral posaconazole...She was admitted with oxygen therapy and TMT-SMX and meropenem, suspecting infection by the same N. wallacei as her brother, which was later confirmed. Nocardia, which often acts only as a coloniser, has a large clinical variability. A history of ABPA is known to be a risk factor for Nocardiosis, so in our cases it is logical to assume that concomitant infection with N. wallacei and A. fumigatus could be a risk..."

Infectious Disease • Respiratory Diseases

LANDCAP-1: Local Antibiotic Delivery for Community Acquired Pneumonia (clinicaltrials.gov) - P2/3 | N=36 | Not yet recruiting | Sponsor: Copenhagen Respiratory Research

New P2/3 trial • Infectious Disease • Pneumonia • Respiratory Diseases

"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients" (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Amgen | Phase classification: P1b ➔ P1

Phase classification • Cystic Fibrosis • Genetic Disorders • Immunology • Pediatrics • Pulmonary Disease • Respiratory Diseases

A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: Amgen | Phase classification: P1b ➔ P1

Phase classification • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluating the effect of sodium alginate and sodium carboxymethylcellulose on pulmonary delivery of levofloxacin spray-dried microparticles. (PubMed, Daru) - "The selected formulation containing SA has the potential to extend the release duration. However, further enhancements are required to optimize its performance."

Journal • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

A retrospective review of fluoroquinolone associated tendinopathy among cystic fibrosis patients in a national cystic fibrosis centre (ECFS 2024) - "The aim was to determine if they had been prescribed ciprofloxacin and/ or Quinsar® (Inhaled levofloxacin) within 6 months prior to the onset of symptoms... A significant number of patients who presented with tendinopathy had taken fluoroquinolones within 6 months of onset of symptoms. Cessation of fluoroquinolone resulted in immediate symptom relief for some patients."

Retrospective data • Review • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Musculoskeletal Pain • Pain • Pulmonary Disease • Respiratory Diseases

Pulmonary infection caused by Dyella species in cystic fibrosis (ECFS 2024) - "At the age of 10, a culture showed scanty growth of a Gram negative, environmental microorganism that was totally resistant to Colistin and had decreased susceptibility to several other antibiotics...Eradication failed, but the girl received several intravenous treatments (using mainly Meropenem and Tigecycline) followed by long courses of inhaled Levofloxacine and oral Trim/Sulfa...In December 2022, Ivacaftor/Tezacaftor/Elexacaftor became available in Sweden, and was initiated... Dyella species is a rare cause of airway colonization in CF but can lead to clinical deterioration."

Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Interim results from a post-marketing observational safety study (PASS) of levofloxacin inhalation solution in patients with cystic fibrosis (ERS 2023) - "Tendon rupture only occurred in DE (<5 patients in LIS and NLIS cohorts). Conclusions Interim results suggest that the safety profile of LIS is comparable to other inhaled antibiotics.; General respiratory patient care; Imaging; Pulmonary function testing; Cell and molecular biology; Epidemiology; Public health"

Clinical • P4 data • Cystic Fibrosis • Fibrosis • Genetic Disorders • Hepatology • Immunology • Pulmonary Disease • Respiratory Diseases

Chronic inhaled antibiotic therapy in people with cystic fibrosis with Pseudomonas aeruginosa infection in Germany. (PubMed, Pulm Pharmacol Ther) - "In all three groups the most commonly used inhaled antibiotic was colistin solution for inhalation. Almost 56% of adults and 44% of children with chronic Pseudomonas infection alternated two antibiotics for inhalation. It will be interesting to see how the introduction of the highly effective modulator elexacaftor/tezacaftor/ivacaftor will change the use of inhaled antibiotics."

Journal • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Differential Performance and Lung Deposition of Levofloxacin with Different Nebulisers Used in Cystic Fibrosis. (PubMed, Int J Mol Sci) - "Zirela showed the best performance considering delivery efficiency (159.6 mg out of a nominal dose of 240 mg), delivery rate (43.5 mg/min), and lung deposition (20% of the nominal dose), requiring less than 5 min to deliver a full dose of levofloxacin. The present study supports the use of drug-specific nebulisers and discourages the off-label use of general-purpose devices with the present levofloxacin formulation since subtherapeutic lung doses and long nebulisation times may compromise treatment efficacy and adherence."

Journal • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Acute pulmonary exacerbation markedly weakens beneficial effect of elexacaftor/tezacaftor/ivacaftor on systemic endothelial dysfunction in cystic fibrosis - a single case study (ECFS 2022) - "Our results showed for the first time that even mild APE can have systemic impacts and transiently overcome beneficial effect of the first triple-combination of CFTR modulators ETI on improvement of SED. Further studies on this very intriguing topic are in progress."

Clinical • Cough • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Using the CFHealthHub digital learning health system to optimise the nebulised medicines supply process in five UK adult cystic fibrosis (CF) centres (ECFS 2022) - " This contact with PWCF has provided a valuable opportunity to re-educate PWCF on appropriate nebulised medicines storage, preparation, disposal and device cleaning. Next steps include contacting all PWCF prescribed nebulised medicines within each centre and demonstrating the cost savings made from delivery delays. CFHH offers a unique opportunity to improve the medicines supply process, reducing waste, saving costs, reducing burden for PWCF and improving patient care."

Clinical • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Pulmonary Targeting of Levofloxacin Using Microsphere-Based Dry Powder Inhalation. (PubMed, Pharmaceuticals (Basel)) - "Furthermore, LVX-loaded microspheres prolonged drug residence time in the lung and maintained a relatively high drug concentration for a longer time, which contributed to a reduced leakage in the systemic circulation. In conclusion, inhalable LVX-loaded microspheres might represent a plausible delivery vehicle for targeting pulmonary tuberculosis via enhancing the therapeutic efficacy of LVX while minimizing its systemic off-target side effects."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Deposition of Inhaled Levofloxacin in Cystic Fibrosis Lungs Assessed by Functional Respiratory Imaging. (PubMed, Pharmaceutics) - "In addition to tobramycin, colistin, and aztreonam, levofloxacin has been approved in Europe to treat PA infections...FRI revealed a significant intrathoracic deposition of levofloxacin aerosols, which distributed preferentially to the lower lung lobes, with an influence of the deterioration of FEV on the C/P ratio. The three-dimensional rendering of CF airways also detected structural differences between the airways of patients with mild and moderate CF."

Journal • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] Late Breaking Abstract - Cumulative retrospective pharmacovigilance review of inhaled levofloxacin: drug-related aneurysms, artery dissection and cardiac valve disorders (ERS 2021) - "Over the 17-years observation period, one ADRs analysed occurred with inhaled levofloxacin formulations. The role of the inhalation route in reducing the occurrence of ADR needs to be further validated."

Adverse events • Late-breaking abstract • Retrospective data • Review • Cardiovascular

[VIRTUAL] Functional respiratory imaging assessment of the aerosol deposition of inhaled levofloxacin in cystic fibrosis lungs (ERS 2021) - "Interestingly, a significant correlation was found between the central-to-peripheral deposition (C/P) ratio and the FEV1pp (p=0.039). Conclusion This FRI study predicts good deposition in patients with mild and moderate CF, and an interesting correlation between FEV1pp and C/P ratio."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Management of chronic Pseudomonas aeruginosa infection with inhaled levofloxacin in people with cystic fibrosis. (PubMed, Future Microbiol) - "Levofloxacin (a fluoroquinolone antimicrobial) has been approved as an inhaled solution in Europe and Canada, for the treatment of adults with CF with chronic P. aeruginosa pulmonary infections. Here, we review the clinical principles relating to the use of inhaled antimicrobials and inhaled levofloxacin for the management of P. aeruginosa infections in patients with CF."

Journal • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] Evolution of levofloxacin resistance and phenotypic characterisation of Pseudomonas aeruginosa clinical isolates from people with cystic fibrosis (ECFS 2021) - "Cross-resistance to other antimicrobials was rare: 5 lineages decreased susceptibility category to aztreonam, imipenem or meropenem. 12 (100%) of lineages also developed resistance to ciprofloxacin in the four isolates tested... High-level levofloxacin resistance is readily induced in Pa clinical isolates from pwCF in vitro . Further work will determine the effect of passaging in the absence of antibiotic and cycling with other inhaled antibiotics on levofloxacin resistance in Pa."

Clinical • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Clinical impact of levofloxacin inhalation solution in cystic fibrosis patients in a real-world setting. (PubMed, J Cyst Fibros) - "In patients with cystic fibrosis, inhaled levofloxacin solution has the potential to improve FEV and to reduce the number of bronchopulmonary exacerbations."

Clinical • Journal • Real-world evidence • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Inhaled levofloxacin: impact of susceptibility testing results on FEV1 and exacerbation rate (ECFS 2020) - "Resistant status of patients with chronic Pseudomonas aeruginosa infection has no clinically significant impact on treatment success. On the contrary, FEV1 and exacerbation rate improve despite resistant Pseudomonas aeruginosa strains."

Chronic Obstructive Pulmonary Disease • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases

Introduction of nebulised levofloxacin in an adult cystic fibrosis centre (ECFS 2020) - "In comparison to patient population size, there has been a small uptake of this treatment at MACFC with majority of use in patients with lower lung function. Tolerability at challenge has been variable although it must be noted that this is a small sample size. Quinsair® continues to be an option for patients who meet criteria, including those with severe lung disease."

Clinical • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Respiratory Diseases