fluticasone and Sleep-Wake-Disorders

Tacrolimus 0.03% ointment is licensed for second-line treatment of children with atopic dermatitis (AD). Although data are available from clinical trials, no study has enrolled only second-line patients. This double-blind, non-inferiority study compared tacrolimus 0.03% and fluticasone 0.005% ointments in children with moderate-to-severe AD, who had responded insufficiently to conventional therapies. Children (aged 2-15 yr) were randomized to tacrolimus ointment (n = 240) or fluticasone ointment (n = 239), twice daily until clearance or for a maximum of 3 wk and, if lesions remained, once daily for up to 3 wk further. Primary end-point was week 3 response rate (improvement of >or=60% in modified Eczema Area and Severity Index and not withdrawn for lack of efficacy). Secondary end-points included pruritus and sleep quality, global assessment of clinical response, incidence of new flares and safety. Response rates were 86.3% with tacrolimus ointment and 91.5% with fluticasone. Lower limit of the 95% confidence interval was -11.8%, exceeding the non-inferiority limit of -15% and meeting the primary end-point. Moderate or better improvement on the physicians' global assessment occurred in 93.6% and 92.4% of patients in the tacrolimus ointment and fluticasone arms, respectively, while median pruritus scores improved by 84.0% and 91.5%. Sleep quality improved by approximately 92% in both treatment arms. After day 21, new flare-up occurred in 5.5% and 11.3% of patients receiving tacrolimus ointment and fluticasone, respectively; mean times to new flares were 6.5 +/- 5.0 and 8.6 +/- 5.2 days. Adverse events were similar between the two arms, with the exception of application-site skin burning sensation in the tacrolimus ointment group. In conclusion, efficacy of tacrolimus 0.03% ointment as second-line treatment was not inferior to that of fluticasone 0.005% ointment, with similar benefits on global disease improvement and quality of sleep.

Topics: Adolescent; Androstadienes; Calcineurin Inhibitors; Child; Child, Preschool; Dermatitis, Atopic; Dermatologic Agents; Female; Fluticasone; Humans; Male; Ointments; Pruritus; Recurrence; Sleep Wake Disorders; Tacrolimus; Treatment Outcome

Asthma and allergic rhinitis are both highly prevalent diseases and often coexist in patients.. To investigate the effect of rhinitis therapy on asthma outcomes in adult and adolescent patients with both seasonal allergic rhinitis (SAR) and persistent asthma.. A total of 863 patients (mean baseline FEV1 81% predicted) were randomized to receive open-label fluticasone propionate/salmeterol (FSC), 100/50 microg bid for 4 weeks, plus either blinded fluticasone propionate aqueous nasal spray (FPANS) 200 microg/d, montelukast 10 mg/d, or placebo. Patients kept daily records of peak expiratory flow (PEF), asthma, and rhinitis symptoms and rescue albuterol use.. FPANS added to FSC resulted in superior outcomes for daytime total nasal symptom scores (D-TNSS) and individual daytime nasal specific symptoms (congestion, rhinorrhea, sneezing, and itching) compared with montelukast plus FSC and placebo plus FSC (p < or = 0.001). Montelukast plus FSC was superior to placebo plus FSC only for D-TNSS and itching and sneezing. Morning PEF, asthma symptoms, and rescue albuterol use improved significantly (p < or = 0.001) in all treatment groups, but improvements were comparable across the treatment groups.. In patients with persistent asthma treated with FSC, the addition of montelukast or FPANS for the treatment of SAR resulted in no additional improvements in overall asthma control compared with FSC alone. However, FPANS provided superior rhinitis control compared with montelukast. These data suggest that asthma and rhinitis should each be optimally treated.

Topics: Acetates; Administration, Inhalation; Adult; Androstadienes; Anti-Asthmatic Agents; Asthma; Cyclopropanes; Female; Fluticasone; Forced Expiratory Volume; Humans; Male; Patient Selection; Quinolines; Reproducibility of Results; Respiratory Distress Syndrome; Respiratory Function Tests; Rhinitis, Allergic, Perennial; Sleep Wake Disorders; Sulfides; Treatment Outcome; Wakefulness

Although in the past drug interventions were measured primarily on the basis of their efficacy and safety, today we are increasingly interested in what impact treatments have on the patient's day-to-day activities and quality of life.. We sought to assess the effect of treatment with fluticasone propionate (FP) on functional status and sleep disturbances in children with asthma and to evaluate possible changes in the quality of life of the parents of these children after treatment.. As part of a randomized, double-blind, parallel-group, placebo-controlled, multicenter study on the effects of FP powder (50 or 100 microg twice daily) on growth in children aged 4 to 11 years with mild-to-moderate asthma (n = 325), parents/caregivers completed the following questionnaires at baseline and at weeks 24 and 52 of treatment: Functional Status IIR (FSII), Sleep Scale-Children (SLP-C), and Quality of Life of Parents of Asthmatic Children (QOL-PAC). Change from baseline to weeks 24 and 52 within each treatment group was analyzed by using paired t-tests, and differences between treatment groups were analyzed by using analysis of covariance.. Mean FSII and SLP-C scores improved significantly over baseline values with either 50 or 100 microg FP at weeks 24 and 52 (p < 0.05) and were significantly better than scores in the placebo group (p < 0.05). In contrast, FSII scores at week 52 and SLP-C scores at weeks 24 and 52 decreased significantly in the placebo group (p < 0.05). QOL-PAC results revealed that scores on the Burden scale were significantly improved in both FP groups at weeks 24 and 52. Subjective Norms and Social scales improved significantly only in the 100 microg FP group at week 52.. The results of this study show that FP (either 50 or 100 microg twice a day) was associated with significant improvements in functional status and decreased sleep disturbances in children with asthma. In addition, treatment of children with FP was associated with a decreased burden on the parents of these children with asthma.

Topics: Administration, Topical; Adult; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Child; Child, Preschool; Double-Blind Method; Female; Fluticasone; Glucocorticoids; Humans; Male; Outcome Assessment, Health Care; Parents; Quality of Life; Sleep Wake Disorders; Surveys and Questionnaires

Children with allergic rhinitis (AR) are reported to have disturbed sleep and daytime fatigue due to nasal obstruction.. To evaluate sleep impairment in children with AR using actigraphic evaluation.. Fourteen children aged 7 to 16 years with grass pollen-sensitized seasonal AR were enrolled. They completed the Total 4-Symptom Score (T4SS) scoring system for AR symptom score and the Pittsburgh Sleep Quality Index (PSQI) questionnaire for sleep quality, and they underwent actigraphy for 3 days in the pretreatment period. After topical corticosteroid and antihistaminic treatment for 8 weeks, actigraphy, the T4SS, and the PSQI were repeated. Fourteen healthy children aged 8 to 16 years underwent actigraphy and completed the PSQI questionnaire as controls.. There were no significant age or sex differences between the AR and control groups. Pretreatment PSQI and actigraphy scores were worse in the AR group vs the control group. After treatment, sleep quality improved, and there were no differences in actigraphy and PSQI scores between the 2 groups. Before treatment, the T4SS was significantly correlated with the sleep efficiency, daytime napping episodes, and total nap duration variables of actigraphy (r = -0.53, P = .004; r = 0.43, P = .02; and r = 0.39, P = .04, respectively). The T4SS was correlated with the total PSQI score (r = 0.67, P < .001).. Sleep can be compromised in children with AR. There is a significant correlation of clinical symptom score with the actigraphic and PSQI variables. Therefore, actigraphy may be used as an objective tool to evaluate sleep disturbance in children with AR.

Topics: Actigraphy; Adolescent; Androstadienes; Anti-Allergic Agents; Cetirizine; Child; Female; Fluticasone; Humans; Male; Rhinitis, Allergic, Seasonal; Sleep Wake Disorders