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- Quinsair (levofloxacin inhalational) / Chiesi, Amgen
Phase classification: "Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients" (clinicaltrials.gov) - Dec 4, 2024
P1, N=27, Completed, Sponsor: Amgen
Phase classification: P1b --> P1
- | levofloxacin / Generic mfg.
Journal: Evaluating the effect of sodium alginate and sodium carboxymethylcellulose on pulmonary delivery of levofloxacin spray-dried microparticles. (Pubmed Central) - Nov 13, 2024
The selected formulation containing SA has the potential to extend the release duration. However, further enhancements are required to optimize its performance.
- Quinsair (levofloxacin inhalational) / Chiesi, Amgen
A retrospective review of fluoroquinolone associated tendinopathy among cystic fibrosis patients in a national cystic fibrosis centre (Exhibition and Poster Area) - Mar 22, 2024 - Abstract #ECFS2024ECFS_690;
However, further enhancements are required to optimize its performance. The aim was to determine if they had been prescribed ciprofloxacin and/ or Quinsar
- Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex, Quinsair (levofloxacin inhalational) / Chiesi, Amgen
Pulmonary infection caused by Dyella species in cystic fibrosis (Exhibition and Poster Area) - Mar 22, 2024 - Abstract #ECFS2024ECFS_442;
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.
- | levofloxacin / Generic mfg.
Journal: Differential Performance and Lung Deposition of Levofloxacin with Different Nebulisers Used in Cystic Fibrosis. (Pubmed Central) - Sep 18, 2022
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.
- | levofloxacin / Generic mfg.
Journal: Pulmonary Targeting of Levofloxacin Using Microsphere-Based Dry Powder Inhalation. (Pubmed Central) - May 30, 2022
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.
- Quinsair (levofloxacin inhalational) / Horizon Therapeutics, Chiesi
Using the CFHealthHub digital learning health system to optimise the nebulised medicines supply process in five UK adult cystic fibrosis (CF) centres (Dock 1) - Apr 14, 2022 - Abstract #ECFS2022ECFS_422;
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.
- Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex
Acute pulmonary exacerbation markedly weakens beneficial effect of elexacaftor/tezacaftor/ivacaftor on systemic endothelial dysfunction in cystic fibrosis - a single case study (ePoster Corner) - Apr 14, 2022 - Abstract #ECFS2022ECFS_157;
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.
- || Quinsair (levofloxacin inhalational) / Horizon Therapeutics, Chiesi
Clinical, Journal, Real-world evidence: Clinical impact of levofloxacin inhalation solution in cystic fibrosis patients in a real-world setting. (Pubmed Central) - Feb 10, 2022
Further studies on this very intriguing topic are in progress. In patients with cystic fibrosis, inhaled levofloxacin solution has the potential to improve FEV and to reduce the number of bronchopulmonary exacerbations.
- | Quinsair (levofloxacin inhalational) / Horizon Therapeutics, Chiesi
Journal: Management of chronic Pseudomonas aeruginosa infection with inhaled levofloxacin in people with cystic fibrosis. (Pubmed Central) - Jan 5, 2022
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.
- | Quinsair (levofloxacin inhalational) / Horizon Therapeutics, Chiesi
Journal: Deposition of Inhaled Levofloxacin in Cystic Fibrosis Lungs Assessed by Functional Respiratory Imaging. (Pubmed Central) - Dec 29, 2021
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.
- | Quinsair (levofloxacin inhalational) / Horizon Therapeutics, Chiesi
Journal: Development and Optimization of Inhalable Levofloxacin Nanoparticles for The Treatment of Tuberculosis. (Pubmed Central) - Nov 4, 2021
The optimized formulation showed a mean particle size of 171.5 nm, sustained the drug release up to 24 h in simulated lung fluid, and revealed MMAD of 3.18 μm, which can confirm delivery of the drug to the deep lung region. However, further in vivo studies are required to design a suitable dosage regimen and establish the fate of nanoparticles for safe and efficacious delivery of the drug.
- Quinsair (levofloxacin inhalational) / Horizon Therapeutics, Chiesi
[VIRTUAL] Late Breaking Abstract - Cumulative retrospective pharmacovigilance review of inhaled levofloxacin: drug-related aneurysms, artery dissection and cardiac valve disorders () - Jul 29, 2021 - Abstract #ERS2021ERS_3722;
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.
- Quinsair (levofloxacin inhalational) / Horizon Therapeutics, Chiesi
[VIRTUAL] Functional respiratory imaging assessment of the aerosol deposition of inhaled levofloxacin in cystic fibrosis lungs () - Jul 29, 2021 - Abstract #ERS2021ERS_3355;
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.
- levofloxacin / Generic mfg.
[VIRTUAL] Evolution of levofloxacin resistance and phenotypic characterisation of Pseudomonas aeruginosa clinical isolates from people with cystic fibrosis (Track 7) - May 10, 2021 - Abstract #ECFS2021ECFS_403;
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.
- | levofloxacin / Generic mfg.
Journal: The effect of metal salts on aerosol performance of spray dried carrier-free formulations of levofloxacin. (Pubmed Central) - Feb 27, 2021
Lower concentrations of NaCl could not improve FPF of leucine containing formulations significantly, but preserves dispersibility in low air flows and high capsule fillings. Graphical abstract.
- Quinsair (levofloxacin inhalational) / Roche, Horizon Therapeutics, Chiesi
Introduction of nebulised levofloxacin in an adult cystic fibrosis centre () - Jun 29, 2020 - Abstract #ECFS2020ECFS_479;
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.
- Quinsair (levofloxacin inhalational) / Roche, Horizon Therapeutics, Chiesi
Inhaled levofloxacin: impact of susceptibility testing results on FEV1 and exacerbation rate () - Jun 29, 2020 - Abstract #ECFS2020ECFS_319;
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.
- | Quinsair (levofloxacin inhalational) / Chiesi, Amgen
Phase classification: A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients (clinicaltrials.gov) - Jan 19, 2018
P1b, N=21, Completed, Sponsor: Horizon Pharma USA, Inc.
On the contrary, FEV1 and exacerbation rate improve despite resistant Pseudomonas aeruginosa strains. Phase classification: P1 --> P1b
- ||||||| Quinsair (levofloxacin inhalational) / Chiesi, Amgen
Trial completion: Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients (clinicaltrials.gov) - Jul 10, 2013
P3, N=267, Completed, Sponsor: Mpex Pharmaceuticals
Phase classification: P1 --> P1b Active, not recruiting --> Completed
- ||||||| Quinsair (levofloxacin inhalational) / Chiesi, Amgen
Trial completion: MP-376 (Aeroquin (clinicaltrials.gov) - Jul 10, 2013
P3, N=330, Completed, Sponsor: Mpex Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed