pulmicort and Sleep-Apnea-Syndromes

Objective To study the efficacy of budesonide nasal spray on the health-related quality of life and symptoms among children with sleep-disordered breathing. Study Design Randomized, parallel, double-blind, placebo-controlled trial. Setting Tertiary referral center. Subjects and Methods Sixty children (ages, 4-10 years) who were referred because of snoring and/or apneas for >3 months were included between January 2015 and June 2016 and randomized in a double-blind design to treatment with 64 μg/mL of budesonide nasal spray (n = 30) or placebo nasal spray (n = 30) twice daily for 6 weeks. The primary outcome measurement was the change in the mean OSA-18 total score from baseline. Other variables examined were individual OSA-18 domains, a visual analog scale for quality of life, symptoms (snoring, apneas, and nasal obstruction), and adenoid and tonsil size. The trial was investigator initiated and not sponsored by the pharmaceutical industry. Results Fifty-five children completed the trial. An intention-to-treat analysis revealed a significantly greater improvement in the mean OSA-18 total score after treatment with budesonide than placebo (19.5 vs 7.5, P = .0014). Intranasal budesonide also improved 2 OSA-18 domains (sleep disturbance, caregivers' concerns), the visual analog scale score for quality of life, as well as snoring, apneas, and nasal obstruction. No serious adverse events were reported that could be linked to the treatment. Conclusion Among children with sleep-disordered breathing, 6 weeks' treatment with intranasal budesonide significantly improved quality of life and symptoms as compared with placebo nasal spray.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Budesonide; Child; Child, Preschool; Double-Blind Method; Female; Humans; Intention to Treat Analysis; Male; Quality of Life; Sleep Apnea Syndromes; Treatment Outcome

Nasal obstruction is recognized as an important cause of sleep disordered breathing. Congestion of the nasal mucosa and obstruction are common symptoms of allergic rhinitis. Daytime sleepiness is a common finding in symptomatic allergic rhinitis. Effective therapy of the nasal congestion of allergic rhinitis should alter sleep patterns in patients with symptomatic allergic rhinitis.. To measure objective changes in polysomnograms (sleep studies) of children with allergic rhinitis before and after therapy with intranasal budesonide and to measure changes in the quality of life of these patients during treatment.. Open clinical trial with objective measurements (polysomnography) and subjective data (Rhinitis Quality of Life Questionnaire [RQLQ]). Evaluations were performed before, during, and at completion of therapeutic intervention.. The 14 studied children tolerated the procedures and treatment without problems. The mean number of sleep arousals per hour (all apneas and hypopneas) decreased from a baseline of 8.4 to 1.2 (P = .005) after treatment. The change was mainly in hypopneic episodes (7.5-0.9, P = .003). Objective responses on the RQLQ showed improvements consistent with improved sleep and lessened rhinitis symptoms.. Decreasing the nasal congestion associated with allergic rhinitis can improve sleep measured by objective sleep studies and lead to improvement in daytime quality of life.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Budesonide; Child; Child, Preschool; Female; Humans; Male; Pilot Projects; Polysomnography; Quality of Life; Rhinitis, Allergic, Perennial; Sleep Apnea Syndromes; Statistics, Nonparametric

Tonsillectomy and adenoidectomy (T&A) is the primary therapeutic approach for sleep-disordered breathing (SDB) in children. However, residual mild SDB will be found in more than one third of these patients after T&A. We hypothesized that combined therapy with the leukotriene receptor antagonist montelukast and intranasal budesonide would result in normalization of residual SDB after T&A.. During the period of October 2002 to February 2005, children who underwent T&A for SDB underwent a routine postoperative (second) overnight polysomnographic evaluation (PSG) 10 to 14 weeks after T&A surgery. In children with residual apnea hypopnea index (AHI) >1 and <5/hour of total sleep time (TST), treatment with montelukast and intranasal budesonide aqueous solution was administered for a period of 12 weeks (M/B group), at which time a third PSG was performed. Children who had residual SDB and did not receive M/B therapy from their treating physicians were recruited as control subjects.. Twenty-two children received M/B, and 14 children served as control subjects. Mean age, gender distribution, ethnicity, and BMI were similar in the 2 treatment groups. The mean AHI at the second PSG was 3.9 +/- 1.2/hour of TST and 3.6 +/- 1.4/hour of TST in M/B-treated and control patients, respectively. Similar nadir arterial oxygen saturation (87.3 +/- 1.2%) and respiratory arousal index (4.6 +/- 0.7/hour of TST) were recorded for both groups. However, the M/B group demonstrated significant improvements in AHI (0.3 +/- 0.3/hour of TST), in nadir arterial oxygen saturation (92.5 +/- 3.0%), and in respiratory arousal index (0.8 +/- 0.7/hour of TST) on the third PSG, whereas no significant changes occurred over time in control subjects.. Combined anti-inflammatory therapy that consists of oral montelukast and intranasal budesonide effectively improves and/or normalizes respiratory and sleep disturbances in children with residual SDB after T&A.

Topics: Acetates; Adenoidectomy; Administration, Intranasal; Administration, Oral; Budesonide; Child; Cyclopropanes; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Leukotriene Antagonists; Male; Polysomnography; Quinolines; Sleep Apnea Syndromes; Sulfides; Tonsillectomy

Topics: Acetates; Anti-Inflammatory Agents; Budesonide; Child; Cyclopropanes; Humans; Leukotriene Antagonists; Polysomnography; Quinolines; Severity of Illness Index; Sleep Apnea Syndromes; Sulfides; Treatment Outcome