Once-Daily Fluticasone Furoate/Vilanterol Versus Once-Daily Fluticasone Furoate in Asthma Patients Aged 5-17 Years.

BACKGROUND: Limited data exist comparing inhaled corticosteroid (ICS) plus adjunctive therapy versus ICS alone in pediatric asthma patients. OBJECTIVE: Evaluate the efficacy and safety of fluticasone furoate/vilanterol (FF/VI) versus FF in children and adolescents with asthma. METHODS: This Phase 3, randomized, double-blind, multicenter study (NCT03248128) included participants aged 5-17 years with ≥6 months' asthma history uncontrolled on ICS monotherapy. Participants received 4 weeks' open-label fluticasone propionate (100 µg) twice daily before 1:1 randomization to 24 weeks' double-blind FF (50 µg:100 µg) or FF/VI (50/25 µg:100/25 µg) once daily. Two populations with different primary endpoints were analyzed to meet United States (Week 12 weighted mean forced expiratory volume in 1 second [FEV1; 0-4 hours]; participants aged 5-17 years) and European (change from baseline pre-dose morning peak expiratory flow [ΔAM PEF] averaged over Weeks 1-12; participants aged 5-11 years) regulator requirements. RESULTS: Overall, 902 participants were randomized and treated, including 673 children aged 5-11 years. In participants aged 5-17, Week 12 weighted mean FEV1 (0-4 hours) was greater with FF/VI versus FF (difference: 0.083 L; P < .001). In participants aged 5-11, ΔAM PEF over Weeks 1-12 showed numerical improvement with FF/VI versus FF but was not statistically significant (difference: 3.2 L/minute; P = .228). No drug-related serious adverse events or deaths were reported. CONCLUSION: FF/VI significantly improved weighted mean FEV1 (0-4 hours; participants aged 5-17 years), but not ΔAM PEF (participants aged 5-11 years) versus FF. No new safety concerns were apparent.

A multicenter randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effects of a 1-year regimen of orally inhaled fluticasone furoate 50 µg once daily on growth velocity in prepubertal, pediatric participants with well-controlled asthma.

INTRODUCTION: Growth impairment is a known adverse event (AE) of corticosteroids in children. This study aimed to assess the effect of once-daily (QD) inhaled fluticasone furoate (FF) versus placebo on growth velocity over 1 year in prepubertal children with well-controlled asthma. MATERIALS AND METHODS: This randomized, double-blind, parallel-group, placebo-controlled, multicenter study (NCT02889809) included prepubertal children, aged 5 to <9 years (boys), and 5 to <8 years (girls), with ≥6 months' asthma history. Children received inhaled placebo QD plus background open-label montelukast QD for a 16-week run-in period and were then randomized 1:1 to receive inhaled FF 50 µg QD or placebo QD (whilst continuing background open-label montelukast) for a 52-week treatment period. The primary endpoint was the difference in growth velocity (cm/year) over the treatment period. Other growth endpoints were measured, as were incidence of AEs and asthma exacerbation. Growth analyses included all intent-to-treat (ITT) participants with ≥3 post-randomization, on-treatment clinic visit height assessments (GROWTH population). RESULTS: Of 644 children in the run-in period, 477 (mean age 6.2 years, 63% male) entered the 52-week treatment period (ITT population: FF N = 238, placebo N = 239; GROWTH population: N = 457 [FF N = 231; placebo N = 226]). The least-squares mean difference in growth velocity for FF versus placebo was -0.160 cm/year (95% confidence interval: -0.462, 0.142). There were no new safety signals. CONCLUSIONS: Over 1 year, FF 50 µg QD had a minimal effect on growth velocity versus placebo, with no new safety signals.

A new formulation of fluticasone propionate/salmeterol in a metered-dose inhaler (MDI HFA) allows for the reduction of a daily dose of corticosteroid and provides optimal asthma control - A randomized, multi-center, non-inferiority, phase IV clinical study.

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.

[Measurement of the passive compliance of the total respiratory system in newborn after respiratory insufficiency for risk assessment of respiratory disorders during the first 6 month of life]. / Pomiar podatnosci ukladu oddechowego u noworodków po przebyciu niewydolnosci oddechowej w ocenie ryzyka wystapienia zaburzen oddechowych w pierwszych 6 miesiacach zycia.

AIMS: To evaluate the relationships between postnatal passive respiratory compliance (Crs) and development of respiratory disorders during the first 6 month of life in preterm and full-term infants after respiratory insufficiency. The purpose of this study was to investigate whether other relevant neonatal factors, like degree of prematurity, birth weigh, ventilatory conditions, sepsis, and respiratory disease severity affected this relationship. MATERIAL AND METHODS: The passive respiratory compliance was measured by the single occlusion technique in 73 preterm infants after respiratory distress syndrome (RDS), 19 full-term infants after congenital pneumonia and 33 healthy full-term infants. Respiratory function measurements were performed by single occlusion technique, during natural sleep, after acute phase of illness, before discharge from neonatal department. RESULTS: Crs was significantly lower in premature newborns < 36 weeks gestation after RDS (p = 0.0002) and in term newborns who have suffered from a congenital pneumonia (p = 0.0411), than in healthy full-term newborn infants. Premature infants who have undergone sepsis have significantly decreased Crs in relationship with those who did not have this complication (p = 0.0334). Preterm newborns who have suffered pneumonia during treatment of RDS have significantly frequent respiratory problems during the first 6 month of age (p = 0.043). Full-term infants after congenital pneumonia have more but not significantly frequent respiratory problems than healthy term newborns (p = 0.055) in this period. Decreased neonatal Crs wasn't significantly related to respiratory disorders in age of 6 month of life. CONCLUSION: Prematurity under 36 week of gestational age, low birth weight and suffering from sepsis in premature infants significantly decreased Crs in newborn. Decreased neonatal Crs in premature and full term infants after respiratory insufficiency wasn't significantly related to respiratory disorders during first 6 month of life. This study has showed significantly increase of respiratory problems in this period in preterm infants who have suffered from pneumonia during neonatal period.

Efficacy and safety of bilastine in reducing pruritus in patients with chronic spontaneous urticaria and other skin diseases: an exploratory study.

Purpose: To evaluate the efficacy/safety of bilastine in pruritus relief in patients with chronic spontaneous urticaria (CSU) or other pruritic skin diseases.Methods: In this multicenter, open-label, exploratory study (EudraCT No.: 2016-001505-17), 115 adults with CSU (n = 34), eczema/dermatitis (n = 30), prurigo (n = 25) or cutaneous pruritus (n = 26), received bilastine 20 mg once daily for 8 weeks, or in non-responder patients (<30% improvement in pruritus score at week 2), 40 mg/day from week 2.Results: The mean change in weekly pruritus severity score from baseline to week 8 (primary endpoint) was reduced with bilastine (overall and by disease group); overall, percentage and absolute reductions were 71.16% and 1.63 points, respectively (p < .001). Updosed non-responders (n = 31) had improved weekly pruritus severity scores from baseline to week 8; percentage and absolute reductions were 49.08% and 1.13 points, respectively (p < .001). Bilastine improved the Dermatology Life Quality Index at weeks 4 and 8 (p < .001) in all disease groups, and the 7-day Urticaria Activity Score in CSU patients (p < .001). Bilastine was well tolerated.Conclusions: Bilastine relieved pruritus associated with urticaria and other skin diseases, with a very good safety profile.