RESUMEN
BACKGROUND: OligoG is a low molecular-weight alginate oligosaccharide that improves the viscoelastic properties of cystic fibrosis (CF) mucus and disrupts biofilms, thereby potentiating the activity of antimicrobial agents. The efficacy of inhaled OligoG was evaluated in adult patients with CF. METHODS: A randomised, double-blind, placebo-controlled multicentre crossover study was used to demonstrate safety and efficacy of inhaled dry powder OligoG. Subjects were randomly allocated to receive OligoG 1050â mg per day (10 capsules three times daily) or matching placebo for 28â days, with 28-day washout periods following each treatment period. The primary end-point was absolute change in percentage predicted forced expiratory volume in 1â s (FEV1) at the end of 28-day treatment. The intention-to-treat (ITT) population (n=65) was defined as randomised to treatment with at least one administration of study medication and post-dosing evaluation. RESULTS: In this study, 90 adult subjects were screened and 65 were randomised. Statistically significant improvement in FEV1 was not observed in the ITT population. Adverse events included nasopharyngitis, cough and pulmonary exacerbation. The number and proportions of patients with adverse events and serious adverse events were similar between OligoG and placebo group. CONCLUSIONS: Inhalation of OligoG-dry powder over 28â days was safe in adult CF subjects. Statistically significant improvement of FEV1 was not reached. The planned analyses did not indicate a significant treatment benefit with OligoG compared to placebo. Post hoc exploratory analyses showed subgroup results that indicate that further studies of OligoG in this patient population are justified.
RESUMEN
Reliable and valid body composition assessment is important in both clinical and research settings. A multitude of methods and techniques for body composition measurement exist, all with inherent problems, whether in measurement methodology or in the assumptions upon which they are based. This review is focused on currently applied methods for in vivo measurement of body composition, including densitometry, bioimpedance analysis, dual-energy X-ray absorptiometry, computed tomography (CT), magnetic resonance techniques and anthropometry. Multicompartment models including quantification of trace elements by in vivo neutron activation analysis, which are regarded as gold standard methods, are also summarized. The choice of a specific method or combination of methods for a particular study depends on various considerations including accuracy, precision, subject acceptability, convenience, cost and radiation exposure. The relative advantages and disadvantages of each method are discussed with these considerations in mind.