ABSTRACT
BACKGROUND: Improvement of the delivery method of inhaled corticosteroids and subsequent dose reduction can minimize the risk of unfavorable outcomes while providing optimal asthma control. OBJECTIVE: This randomized, multi-center, non-inferiority, phase IV clinical study compared the efficacy and safety of a new formulation of fluticasone propionate/salmeterol (250 µg/50 µg, twice daily) administered in a metered-dose inhaler hydrofluoroalkane (MDI HFA) with a dry-powder inhaler (DPI) containing fluticasone propionate/salmeterol (500 µg/50 µg, twice daily). METHODS: Adults with asthma (n = 231) were randomly assigned to either the study group (treated for 12 weeks with fluticasone propionate/salmeterol MDI HFA) or a control group (treated for 12 weeks with fluticasone propionate/salmeterol DPI). Asthma symptoms, exacerbations, short-acting ß2-agonist (SABA) use, physical activity, lung function, and general health status were assessed during four study visits. RESULTS: Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity. Comparable improvement in peak expiratory flow ([MDI HFA] from 6.2 ± 0.2 to 6.6 ± 0.2 l/s vs. [DPI] from 6.0 ± 0.2 to 6.9 ± 0.2 l/s; p > 0.05), forced expiratory volume in one second, and forced vital capacity were obtained in both groups. Significantly lower incidence of hoarseness was observed in the study group ([MDI HFA] 0.0% vs. [DPI] 2.8%; p = 0.0267); no major differences were found for other adverse events. CONCLUSIONS: Fluticasone propionate/salmeterol (250 µg/50 µg, twice daily) MDI HFA provides optimal asthma control and is non-inferior to fluticasone propionate/salmeterol (500 µg/50 µg, twice daily) DPI.
Subject(s)
Adrenal Cortex Hormones/administration & dosage , Drug Tapering/methods , Metered Dose Inhalers , Administration, Inhalation , Adolescent , Adult , Aged , Asthma/drug therapy , Female , Fluticasone-Salmeterol Drug Combination/administration & dosage , Humans , Male , Middle Aged , Treatment Outcome , Young AdultABSTRACT
Pulmonary actinomycosis is a rare disease caused by Actinomyces sp. Its symptoms and radiological findings are not characteristic, so the diagnosis might be difficult to establish. We report a case of a 59 year old male, who developed bronchopulmonary Actinomycosis due to poor dental hygiene. The infectious process affected lung parenchyma and infiltrated chest wall causing multifocal sternal osteolisis and multiple cutaneous fistulas. The radiological findings sugested neoplasmatical process. The diagnosis was based on histopatological findings of fistular scrapes. The material contained Actinomyces colonies. Afler 6 months of antibiotic therapy the patient's state improved and the cutaneous fistulas healed. Radiological finding revealed partial resolution of the lung infiltration.
