The effect of high-dose fluticasone propionate and budesonide on lung function and asthma exacerbations in patients with severe asthma

AbstractThe purpose of this study was to investigate the comparative efficacy and safety of equal doses of inhaled fluticasone propionate (FP) and inhaled budesonide (BUD) using their respective dry powder inhalers in a population of severe asthmatics requiring high doses of inhaled corticosteroid. This double-blind double-dummy parallel-group study compared the effects of 24 weeks of treatment with FP (2000 μg daily via a Diskhaler® inhaler; Glaxo Wellcome, Evreux, France) and BUD (2000 μg daily via a Turbuhaler® inhaler; Astra Pharmaceuticals, Rijswijka, Netherlands) on lung function and asthma exacerbations in 395 patients with asthma.FP was statistically significantly superior to BUD with respect to the percentage of symptom-free days (P = 0·02), the incidence of days free from rescue bronchodilator usage (P = 0·02) and the distribution of change in peak expiratory flow (PEF) expressed as a percentage of the predicted PEF (P = 0·04). During the treatment period FP was statistically significantly superior to BUD for change in forced expiratory volume in 1 sec (FEV1) at 8, 16 and 24 weeks, change in the median daytime symptom score during weeks 5–16, for incidence of symptomfree days and incidence of days free from rescue bronchodilator usage during weeks 17–24. There was no significant difference between FP and BUD with respect to the number of patients experiencing one or more asthma exacerbation (33·8 and 28·4% of patients, respectively). There was, however, evidence that the exacerbations were clinically less severe in patients treated with FP, in that the time to resolution was quicker (11·0 vs. 14·7 days; P = 0·035), mean duration of all exacerbations (for an individual patient) tended to be shorter (18·5 vs. 23·6 days; P = 0·12), the time off work was reduced (4·2 vs. 7·6 days; P = 0·012) and the lowest PEF recorded during the exacerbation was higher (301 vs. 263 1 min−1; P = 0·07). There were no clinically relevant differences in the safety (serum cortisol levels, markers of bone turnover, adverse events) of FP and BUD at these microgram equivalent doses.The patients recruited into this study, in retrospect, probably had no need for such high doses of inhaled corticosteroid but, irrespective of this, FP at microgram equivalent doses showed evidence of superior efficacy to BUD with respect to lung function and severity of asthma exacerbations without producing any greater adverse systemic effect

Family-based obesity prevention for infants: Design of the “Mothers & Others” randomized trial

Objective Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the first two years of life. Design, participants, and methods The design is a two-group randomized controlled trial among 468 AA pregnant women in central North Carolina. Mothers and study partners in the intervention group receive anticipatory guidance on breastfeeding, responsive feeding, use of non-food soothing techniques for infant crying, appropriate timing and quality of complementary feeding, age-appropriate infant sleep, and minimization of TV/media. The primary delivery channel is 6 home visits by a peer educator, 4 interim newsletters and twice-weekly text messaging. Intervention families also receive 2 home visits from an International Board Certified Lactation Consultant. Assessments occur at 28 and 37 weeks gestation and when infants are 1, 3, 6, 9, 12, and 15 months of age. Results The primary outcome is infant/toddler growth and likelihood of overweight at 15 months. Differences between groups are expected to be achieved through uptake of the targeted infant feeding and care behaviors (secondary outcomes) and change in caregivers' modifiable risk factors (mediators) underpinning the intervention. Conclusions If successful in promoting healthy infant growth and enhancing caregiver behaviors, “Mothers and Others” will have high public health relevance for future obesity-prevention efforts aimed at children younger than 2 years, including interventional research and federal, state, and community health programs. Trial Registration ClinicalTrials.gov, NCT01938118, August 9, 2013

Inter- and intragrain currents in bulk melt-grown YBaCuO rings

A simple contactless method suitable to discern between the intergrain (circular) current, which flows in the thin superconducting ring, and the intragrain current, which does not cross the weakest link, has been proposed. At first, we show that the intergrain current may directly be estimated from the magnetic flux density $B(\pm z_0)$ measured by the Hall sensor positioned in the special points $\pm z_0$ above/below the ring center. The experimental and the numerical techniques to determine the value $z_0$ are discussed. Being very promising for characterization of a current flowing across the joints in welded YBaCuO rings (its dependencies on the temperature and the external magnetic field as well as the time dissipation), the approach has been applied to study corresponding properties of the intra- and intergrain currents flowing across the $a$-twisted grain boundaries which are frequent in bulk melt-textured YBaCuO samples. We present experimental data related to the flux penetration inside a bore of MT YBaCuO rings both in the non-magnetized, virgin state and during the field reversal. The shielding properties and their dependence on external magnetic fields are also studied. Besides, we consider the flux creep effects and their influence on the current re-distribution during a dwell.Comment: 13 pages, 16 figures (EPS), RevTeX4. In the revised version, corrections to perturbing effects near the weak links are introduced, one more figure is added. lin

Breastfeeding best start study: training midwives in a 'hands off' positioning and attachment intervention

The most common reasons cited by women for giving up breastfeeding early can be attributed to ineffective positioning and attachment and are therefore preventable. This study aimed to determine whether a 4-h training programme in 'hands off' positioning and attachment support increases midwives' knowledge and problem-solving skills. Using an unrelated comparison group and a pre- and post-intervention design, 108 midwives (experimental group) completed a 4-h standard breastfeeding training workshop focusing on effective positioning and attachment and the use of hands-off teaching methods. Knowledge and problem-solving skills were assessed using a modified form of the previously validated Breastfeeding Support Skills Tool. Pre- and post-training scores were compared with those of 27 student midwives (control group) who undertook the same assessments but without the breastfeeding training. Baseline knowledge scores of the midwives and the student midwives did not differ significantly (average difference 0.7 points to qualified midwives' advantage, 95% CI = -3.4 to 1.9). Following training, the qualified midwives' total scores increased significantly (7.2 points, +95% CI = 6.2-8.2). Minimal changes (1.4 points, 95% CI = -0.15 to 2.9) in students' scores were found. The additional increase owing to training above that which might be expected due to practice (i.e. the average difference in change scores between the two groups) was 5.8 points (95% CI = 3.75-7.96), representing a large effect size for the training (d = 0.95). There is a large variation in the breastfeeding knowledge of midwives working in post-natal care and, on average, they are no more skilled than senior student midwives. The study has shown that a 4-h workshop in a positioning and attachment intervention, using a 'hands-off' approach, can increase midwives' knowledge of breastfeeding support relevant to the immediate post-natal period. It is applicable to all midwives, and could be a cost-effective way of improving the ability of mothers to begin and continue to breastfeed successfully