montelukast and Sleep-Wake-Disorders

Previous studies have suggested that asthmatics have an increased incidence of sleep disturbances. However, these studies have been limited by reliance on population surveys or small numbers of participants.. We sought to measure sleep quality and daytime sleepiness in a cohort of symptomatic asthmatics and to measure the effects of improved asthma control on sleep quality.. Data were collected in sub-study of a large multi-center randomized double-masked controlled trial of mild-moderate asthmatics evaluating the effect of low-dose theophylline on asthma control in comparison to montelukast and placebo. Each participant was administered sleep symptom questionnaires at randomization and at the final visit (6 months after randomization). These included the Pittsburgh Sleep Quality Questionnaire (PSQI) and the Epworth Sleepiness Scale (ESS).. Data were available for 487 participants. Baseline mean values were: age 40 +/- 15 years, 74% female, forced expiratory volume in 1 second (FEV(1)) 79 +16 percent predicted, Juniper Asthma Control Questionnaire (ACQ) score 2.35 +/- 0.63, PSQI 7.8 +/-4, and ESS 8.5 +/-4.9. There were no significant differences in the PSQI or ESS between the three treatment groups. Significant correlations were found at baseline between the global PSQI score and ACQ and quality of life and marginally with lung function. Significant correlation existed between improvements in PSQI and ESS with improved asthma control and quality of life.. Sleep disturbances are common in asthmatics and are associated with asthma control and quality of life. Clinicians caring for asthmatics may need to complete a more detailed sleep history in patients with poorly controlled asthma. In addition, low-dose theophylline does not seem to impair sleep quality in asthmatics.

Topics: Acetates; Adult; Asthma; Bronchodilator Agents; Cyclopropanes; Double-Blind Method; Female; Humans; Leukotriene Antagonists; Male; Quality of Life; Quinolines; Respiratory Function Tests; Sleep Wake Disorders; Sulfides; Surveys and Questionnaires; Theophylline

Obesity is a risk factor for being diagnosed with asthma, but there is conflicting evidence on whether obesity is a risk factor for lung function abnormalities characteristic of asthma. We studied a cohort of 488 subjects, 47% of whom were obese. Obese and non-obese subjects with asthma had similar airflow limitation and bronchodilator responsiveness, but obese participants had increased sleep disturbance and gastroesophageal reflux disease, higher cytokine levels, and a trend towards increased exacerbations when treated with theophylline. Obese and non-obese asthmatics have similar lung function abnormalities, but comorbidities and altered responses to medications may significantly affect asthma control in obese people.

Topics: Acetates; Adult; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Cyclopropanes; Cytokines; Disease Progression; Double-Blind Method; Female; Forced Expiratory Volume; Gastroesophageal Reflux; Humans; Male; Middle Aged; Obesity; Quinolines; Risk Factors; Sleep Wake Disorders; Sulfides; Theophylline; Treatment Outcome; Vital Capacity

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 montelukast is generally well tolerated, postmarketing studies have reported serious neuropsychiatric adverse drug reactions (ADRs) leading to a United States Food and Drug Administration black box warning. The objective of this study was to determine the incidence of neuropsychiatric ADRs leading to discontinuation of montelukast in asthmatic children.We conducted a retrospective cohort study in children aged 1-17 years initiated on montelukast. In a nested cohort study, children initiated on montelukast as monotherapy or adjunct therapy to inhaled corticosteroids (ICS) were matched to those initiated on ICS monotherapy. A non-leading parental interview served to ascertain the occurrence of any ADRs with any asthma medication, and circumstances related to, and evolution of, the event.Out of the 106 participants who initiated montelukast, most were male (58%), Caucasian (62%) with a median (interquartile range) age of 5 (3-8) years. The incidence (95% CI) of drug cessation due to neuropsychiatric ADRs was 16 (10-26)%, mostly occurring within 2 weeks. Most frequent ADRs were irritability, aggressiveness and sleep disturbances. The relative risk of neuropsychiatric ADRs associated with montelukast

Topics: Acetates; Adolescent; Aggression; Anti-Asthmatic Agents; Asthma; Canada; Child, Preschool; Cyclopropanes; Drug Therapy, Combination; Drug-Related Side Effects and Adverse Reactions; Female; Glucocorticoids; Humans; Infant; Irritable Mood; Male; Neuropsychological Tests; Product Surveillance, Postmarketing; Quinolines; Retrospective Studies; Sleep Wake Disorders; Sulfides; Withholding Treatment