Trial reportAntimicrobial agents and chemotherapy2011
Pharmacokinetics and safety of MP-376 (levofloxacin inhalation solution) in cystic fibrosis subjects.
Trial report in Antimicrobial agents and chemotherapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 69 citations in OpenAlex.
- Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis.The Cochrane database of systematic reviews · 2022Pooled it
- Treatment for chronic methicillin-sensitive Staphylococcus aureus pulmonary infection in people with cystic fibrosis.The Cochrane database of systematic reviews · 2018Pooled it
- Development and Characterization of Spray-Dried Combined Levofloxacin-Ambroxol Dry Powder Inhaler Formulation.Pharmaceutics · 2024Article
- Cystic Fibrosis: Recent Insights into Inhaled Antibiotic Treatment and Future Perspectives.Antibiotics (Basel, Switzerland) · 2021Review
- Liquid Chromatography Mass Spectrometry Detection of Antibiotic Agents in Sputum from Persons with Cystic Fibrosis.Antimicrobial agents and chemotherapy · 2021Article
- Accelerated Approval or Risk Reduction? How Response Biomarkers Advance Therapeutics through Clinical Trials in Cystic Fibrosis.Trends in molecular medicine · 2020Review
- The effect of metal salts on aerosol performance of spray dried carrier-free formulations of levofloxacin.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2020Article
- Control of the Lung Residence Time of Highly Permeable Molecules after Nebulization: Example of the Fluoroquinolones.Pharmaceutics · 2020Review
- The Rationale and Evidence for Use of Inhaled Antibiotics to Control Pseudomonas aeruginosa Infection in Non-cystic Fibrosis Bronchiectasis.Journal of aerosol medicine and pulmonary drug delivery · 2018Review
- Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis.The Cochrane database of systematic reviews · 2018Review
- Strategies for the etiological therapy of cystic fibrosis.Cell death and differentiation · 2017Review
- Community Composition Determines Activity of Antibiotics against Multispecies Biofilms.Antimicrobial agents and chemotherapy · 2017Article
- New and Emerging Treatments for Cystic Fibrosis.Drugs · 2015Review
- Clinical pharmacokinetics of inhaled antimicrobials.Clinical pharmacokinetics · 2015Review
- Management of Pseudomonas aeruginosa infection in cystic fibrosis patients using inhaled antibiotics with a focus on nebulized liposomal amikacin.Future microbiology · 2015Review
- Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis.BMJ open respiratory research · 2015Article
- Pharmacokinetics and pharmacodynamics of aerosolized antibacterial agents in chronically infected cystic fibrosis patients.Clinical microbiology reviews · 2014Review
- Antibiotic management of lung infections in cystic fibrosis. I. The microbiome, methicillin-resistant Staphylococcus aureus, gram-negative bacteria, and multiple infections.Annals of the American Thoracic Society · 2014Review
- Development of levofloxacin inhalation solution to treat Pseudomonas aeruginosa in patients with cystic fibrosis.Therapeutic advances in respiratory disease · 2014Review
- Pseudomonas aeruginosa infection in cystic fibrosis lung disease and new perspectives of treatment: a review.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The pharmacokinetics and tolerability of nebulized MP-376 (levofloxacin inhalation solution [Aeroquin]) were determined in cystic fibrosis (CF) subjects. Ten CF subjects received single 180-mg doses of two formulations of MP-376, followed by a multiple-dose phase of 240 mg once daily for 7 days. Serum and expectorated-sputum samples were assayed for levofloxacin content. Safety was evaluated following the single- and multiple-dose study phases. Nebulized MP-376 produced high concentrations of levofloxacin in sputum. The mean maximum plasma concentration (C(max)) ranged between 2,563 and 2,932 mg/liter for 180-mg doses of the 50- and 100-mg/ml formulations, respectively. After 7 days of dosing, the mean C(max) for the 240-mg dose was 4,691 mg/liter. The mean serum levofloxacin C(max) ranged between 0.95 and 1.28 for the 180-mg doses and was 1.71 for the 240-mg dose. MP-376 was well tolerated. Nebulized MP-376 produces high sputum and low serum levofloxacin concentrations. The pharmacokinetics, safety, and tolerability were similar for the two formulations. MP-376 240 mg (100 mg/ml) is being advanced into late-stage clinical development.
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