ArticleAntimicrobial agents and chemotherapy2013
Phase I, single-dose, dose-escalating study of inhaled dry powder capreomycin: a new approach to therapy of drug-resistant tuberculosis.
Article in Antimicrobial agents and chemotherapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.
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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.
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Who cites it
44 citing papers in PubMed, 135 citations in OpenAlex.
- Review
- Stabilized Extracellular Vesicle Formulations for Inhalable Dry Powder Development.Small (Weinheim an der Bergstrasse, Germany) · 2026Article
- Outstanding Contributions to Aerosol Pulmonary Drug Delivery.Kona : powder science and technology in Japan · 2026Article
- Formulation and clinical translation of inhalable nanomedicines for the treatment and prevention of pulmonary infectious diseases.Drug delivery and translational research · 2025Review
- Prospects of Inhalable Formulations of Conventionally Administered Repurposed Drugs for Adjunctive Treatment of Drug-Resistant Tuberculosis: Supporting Evidence from Clinical Trials and Cohort Studies.Journal of aerosol medicine and pulmonary drug delivery · 2025Review
- Optimization, In Vitro, and In Silico Characterization of Theophylline Inhalable Powder Using Raffinose-Amino Acid Combination as Fine Co-Spray-Dried Carriers.Pharmaceutics · 2025Article
- Innovative Strategies for Combating Multidrug-Resistant Tuberculosis: Advances in Drug Delivery Systems and Treatment.Microorganisms · 2025Review
- Targeted delivery of antitubercular drugs using glucan lipid particles.Microbiology spectrum · 2025Article
- Design of Experiment (DoE) Approach for Developing Inhalable PLGA Microparticles Loaded with Clofazimine for Tuberculosis Treatment.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Excipients for Novel Inhaled Dosage Forms: An Overview.AAPS PharmSciTech · 2024Review
- Advanced drug delivery and therapeutic strategies for tuberculosis treatment.Journal of nanobiotechnology · 2023Review
- Pharmacokinetic Considerations for Optimizing Inhaled Spray-Dried Pyrazinoic Acid Formulations.Molecular pharmaceutics · 2023Article
- Inhaled Adjunct Therapy with Second-Line Drug Candidates for Dose Reduction in Chemotherapeutic Regimens for Multi-drug-Resistant Tuberculosis.AAPS PharmSciTech · 2023Article
- Efficacy and Safety of Dry Powder Antibiotics: A Narrative Review.Journal of clinical medicine · 2023Review
- A review of formulations and preclinical studies of inhaled rifampicin for its clinical translation.Drug delivery and translational research · 2023Review
- Microbiological profile, preclinical pharmacokinetics and efficacy of CRS0393, a novel antimycobacterial agent targeting MmpL3.Tuberculosis (Edinburgh, Scotland) · 2023Article
- Optimization and Scale Up of Spray Dried CPZEN-45 Aerosol Powders for Inhaled Tuberculosis Treatment.Pharmaceutical research · 2022Article
- AllCurrent research in immunology · 2022Review
- Spray-Dried Powder Formulation of Capreomycin Designed for Inhaled Tuberculosis Therapy.Pharmaceutics · 2021Article
- Optimizing Spray-Dried Porous Particles for High Dose Delivery with a Portable Dry Powder Inhaler.Pharmaceutics · 2021Review
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
Abstract
Multidrug-resistant tuberculosis (MDR-TB) threatens global TB control. The lengthy treatment includes one of the injectable drugs kanamycin, amikacin, and capreomycin, usually for the first 6 months. These drugs have potentially serious toxicities, and when given as intramuscular injections, dosing can be painful. Advances in particulate drug delivery have led to the formulation of capreomycin as the first antituberculosis drug available as a microparticle dry powder for inhalation and clinical study. Delivery by aerosol may result in successful treatment with lower doses. Here we report a phase I, single-dose, dose-escalating study aimed at demonstrating safety and tolerability in healthy subjects and measuring pharmacokinetic (PK) parameters. Twenty healthy adults (n = 5 per group) were recruited to self-administer a single dose of inhaled dry powder capreomycin (25-mg, 75-mg, 150-mg, or 300-mg nominal dose) using a simple, handheld delivery device. Inhalations were well tolerated by all subjects. The most common adverse event was mild to moderate transient cough, in five subjects. There were no changes in lung function, audiometry, or laboratory parameters. Capreomycin was rapidly absorbed after inhalation. Systemic concentrations were detected in each dose group within 20 min. Peak and mean plasma concentrations of capreomycin were dose proportional. Serum concentrations exceeded 2 μg/ml (MIC for Mycobacterium tuberculosis) following the highest dose; the half-life (t1/2) was 4.8 ± 1.0 h. A novel inhaled microparticle dry powder formulation of capreomycin was well tolerated. A single 300-mg dose rapidly achieved serum drug concentrations above the MIC for Mycobacterium tuberculosis, suggesting the potential of inhaled therapy as part of an MDR-TB treatment regimen.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.