Effectiveness and Safety of Inhaled Antibiotics in Patients With Chronic Obstructive Pulmonary Disease. A Multicentre Observational Study

BackgroundWe aimed to describe the effectiveness and safety of inhaled antibiotics in chronic obstructive pulmonary disease (COPD) patients, as well as the patient profile in which they are usually prescribed and the patient groups that can most benefit from this treatment.MethodsMulticentre retrospective observational cohort study in COPD patients who had received ≥1 dose of inhaled antibiotics in the last 5 years. Clinical data from the two years prior to and subsequent to the start of the treatment were compared. Primary outcome: COPD exacerbations. Secondary outcomes: side effects, symptomatology (sputum purulence, dyspnoea), microbiological profile and pathogen eradication.ResultsOf 693 COPD patients analyzed (aged 74.1; 86.3% men; mean FEV₁ = 43.7%), 71.7% had bronchiectasis and 46.6% presented chronic bronchial infection (CBI) by Pseudomonas aeruginosa (PA). After 1 year of treatment with inhaled antibiotics, there was a significant decrease in the number of exacerbations (?33.3%; P < .001), hospital admissions (?33.3%; P < .001) and hospitalization days (?26.2%; P = .003). We found no difference in effectiveness between patients with or without associated bronchiectasis. Positive patient outcomes were more pronounced in PA-eradicated patients. We found a significant reduction in daily expectoration (?33.1%; P = .024), mucopurulent/purulent sputum (?53.9%; P < .001), isolation of any potentially pathogenic microorganisms (PPM) (?16.7%; P < .001), CBI by any PPM (?37.4%; P < .001) and CBI by PA (?49.8%; P < .001). CBI by any PPM and ≥three previous exacerbations were associated with a better treatment response. 25.4% of patients presented non-severe side-effects, the most frequent of these being bronchospasm (10.5%), dyspnoea (8.8%) and cough (1.7%).ConclusionsIn COPD patients with multiple exacerbations and/or CBI by any PPM (especially PA), inhaled antibiotics appear to be an effective and safe treatment, regardless of the presence of bronchiectasis.     

雾化吸入鱼腥草注射液加生脉注射液治疗慢性支气管炎急性发作42例观察

目的观察雾化吸入鱼腥草注射液配合生脉注射液治疗慢性支气管炎急性发作期的效果。方法治疗组在常规抗感染等措施基础上用鱼腥草注射液雾化吸入配合生脉注射液静滴治疗42例,并设对照组用常规抗感染等措施治疗42例。结果治疗组总有效率为95.2%,对照组总有效率为75.0%,两组疗效比较有显著性差异(P<0.05),治疗组优于对照组。两组氧分压、二氧化碳分压、T淋巴细胞亚群变化疗效比较有显著性差异(P<0.05),治疗组优于对照组。结论鱼腥草注射液雾化吸入配合生脉注射液治疗慢性阻塞性肺病急性发作期患者,可以有效改善症状,缩短病程。     

Breathe easy: 5 steps to better breathing with your metered-dose inhaler (MDI)

Proper use of the metered-dose inhaler (MDI) is essential for medications to prevent and treat acute asthma exacerbations. This training video teaches children and clinicians correct technique for MDI use.     

A Generalized Pivotal Quantity Approach to the Parametric Tolerance Interval Test for Dose Content Uniformity Batch Testing

The Food and Drug Administration (FDA) has proposed a parametric tolerance interval test (PTIT) for batch-release testing of inhalation devices. The proposed test examines dose uniformity based on several inhalation units from a batch, with two observations per unit. An underlying assumption is that the observations are a random sample from a univariate normal distribution. Because there are two observations per unit, it may be more appropriate to model the data as stemming from a bivariate normal distribution. We take a bivariate approach and use generalized confidence interval methodology to derive a parametric tolerance interval for the distribution of doses within a batch. We then use Monte Carlo simulation to compare results based on this bivariate approach with those based on the FDA-proposed PTIT.     

Comparative study of mucoadhesive and mucus-penetrative nanoparticles based on phospholipid complex to overcome the mucus barrier for inhaled delivery of baicalein

Efficient mucosal delivery remains a major challenge for the reason of the respiratory tract mucus act as a formidable barrier to nanocarriers by trapping and clearing foreign particulates. The surface property of nanoparticles determines their retention and penetration ability within the respiratory tract mucus. However, the interaction between nanoparticles and mucus, and how these interactions impact distribution has not been extensively investigated. In this study, polymeric nanoparticles loaded with a baicalein–phospholipid complex were modified with two kinds of polymers, mucoadhesive and mucus-penetrative polymer. Systematic investigations on the physicochemical property, mucus penetration, transepithelial transport, and tissue distribution were performed to evaluate the interaction of nanoparticles with the respiratory tract. Both nanoparticles had a similar particle size and good biocompatibility, exhibited a sustained-release profile, but showed a considerable difference in zeta potential. Interestingly, mucus-penetrative nanoparticles exhibited a higher diffusion rate in mucus, deeper penetration across the mucus layer, enhanced in vitro cellular uptake, increased drug distribution in airways, and superior local distribution and bioavailability as compared to mucoadhesive nanoparticles. These results indicate the potential of mucus-penetrative nanoparticles in design of a rational delivery system to improve the efficiency of inhaled therapy by promoting mucus penetration and increasing local distribution and bioavailability.     

Fluticasone furoate/vilanterol once daily improves night-time awakenings in asthma patients with night symptoms: Post hoc analyses of three randomized controlled trials

Objective: Symptoms, including night-time awakenings, affect the quality of life of people with asthma. Fluticasone furoate/vilanterol (FF/VI) reduces exacerbations, improves lung function, and rescue-free and symptom-free 24-hour periods in patients with asthma. These post hoc analyses compared daytime and night-time symptoms in patients with asthma who received FF/VI, versus FF, fluticasone propionate (FP) or placebo.

Methods: Daytime and night-time symptoms were collected via electronic daily diary cards in three Phase III randomized studies of once-daily FF/VI in patients with uncontrolled asthma on inhaled corticosteroids (ICSs) ± long-acting beta₂ agonists (n = 609/1039/586).

Endpoints included change from baseline in symptom-free days and nights (analyzed by Analysis of Covariance, covariates: baseline, region, sex, age, and treatment), time for patients to achieve seven consecutive symptom-free nights (analyzed by Cox proportional hazards' model, covariates as above), and proportion of patients experiencing 100% symptom-free nights per week (analyzed by logistic regression, covariates: percentage of symptom-free nights, sex, age, and treatment).

Results: Improvements in symptom-free days and nights were generally observed for all treatments. More patients who received FF/VI experienced 100% symptom-free nights in the last week of the treatment period than patients who received ICS alone or placebo. FF/VI also reduced time to achieve seven consecutive symptom-free nights. Patients with at least one night of symptoms at baseline experienced an additional 2.7 and 2.0 symptom-free nights per week with FF/VI 100/25 µg, versus 1.9 and 1.7 with FF alone; similar findings were seen with FF/VI 200/25 µg.

Conclusions: Benefits in terms of symptom-free days and nights were observed for patients receiving FF/VI versus comparators in these post hoc analyses.