The vaginal microbiome is a highly dynamic environment that is altered with changes in vaginal pH [1,2]. Even small increases in vaginal pH, such as those associated with menstruation, can cause a shift in the predominant bacterial species present in the vagina [1,3].An acidic pH and colonization with Lactobacillus species (LB) are important components of the vagina's natural defense mechanisms against infections [2,4,5]. In vitro, LB acidify their growth medium to a pH of 3.2 to 4.8, a range that is similar to the average healthy vagina [6,7]. However, disruption of this equilibrium may reduce the presence of LB, which causes a subsequent rise in vaginal pH and possible overgrowth of abnormal flora, since many pathogenic organisms require a pH > 4.5 for growth [8][9][10][11][12][13][14][15]. Therefore, maintaining a vaginal pH around 4.0 to 4.5 could help prevent recurrence of bacterial vaginosis (BV) [6]. The development of options for prevention of recurrent BV is of significant interest, as women who are diagnosed with BV may have a greater than 50% risk of recurrence in the subsequent 12 months [16]. In addition, BV has been associated with increased risk of pre-term delivery, low birth weight infants, miscarriage, and acquisition of sexu-ally transmitted infections [17,18].Recently, there has been interest in developing a vaginal preparation with the capacity to work as both a contraceptive and a microbicide. Amphora vaginal gel (AVG) is a multipurpose vaginal pH regulator (MVP-R) under evaluation as an on-demand contraceptive (NCT03243305), to prevent certain sexually transmitted infections (NCT03107377), and potentially reduce recurrence of BV after intravaginal administration. It has been demonstrated that AVG is well-tolerated and results in a low vaginal pH; however, the duration of this effect has not been clearly established [6,19]. Therefore, the primary objective of this study (NCT02693418) was to assess change from baseline in vaginal pH after intravaginal administration of a single dose (5, 4, or 3 grams) of AVG, placebo gel, or no treatment, and to measure the duration of this change. Materials and Methods
The European Respiratory Society (ERS) International Congress was held in Munich, Germany, on 6th– 10th September 2014, and was a particularly important opportunity for leading experts to share recent developments and new clinical evidence for the management of chronic obstructive pulmonary disease (COPD). In recent years, new emerging therapies have allowed patients to benefit from improved clinical outcomes and quality of life, with acceptable toxicities. The 2014 guidelines of the Global Initiative for Chronic Obstructive Lung Disease identified symptom reduction as the main goal of moderate-to- severe COPD management. Combined bronchodilation therapy with different therapeutic classes was recommended as a strategy to ensure improved symptom control while containing adverse events, as opposed to monotherapy. Moreover, combination inhaled bronchodilators that are administered once- daily can improve compliance, compared to twice-daily modalities. This review will summarise newly presented clinical data at ERS 2014, providing further information on the efficacy and safety of such combinations, clinical evidence regarding COPD presentation in various populations, strategies for optimal drug delivery, and safety profile monitoring for recent therapeutic options.
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