pulmicort and Respiratory-Sounds

Although nebulized corticosteroids (NebCSs) are a key treatment option for young children with asthma or viral-induced wheezing (VIW), there are no uniform recommendations on their best use. This systematic review aimed to clarify the role of NebCSs in children 5 years or younger for the management of acute asthma exacerbations, asthma maintenance therapy, and the treatment of VIW. Electronic databases were used to identify relevant English language articles with no date restrictions. Studies reporting efficacy data in children 5 years or younger, with a double-blind, placebo- or open-controlled, randomized design, and inclusion of 40 or more participants (no lower patient limit for VIW) were included. Ten articles on asthma exacerbation, 9 on asthma maintenance, and 7 on VIW were identified. Results showed NebCSs to be at least as efficacious as oral corticosteroids in the emergency room for the management of mild to moderate asthma exacerbations. In asthma maintenance, nebulized budesonide, the agent of focus in all trials analyzed, significantly reduced the risk of further asthma exacerbations compared with placebo, cromolyn sodium, and montelukast. Intermittent NebCS treatment of VIW was as effective as continuous daily treatment. In summary, NebCSs are effective and well tolerated in patients 5 years or younger for the management of acute and chronic asthma.

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Asthma; Budesonide; Child; Child, Preschool; Humans; Randomized Controlled Trials as Topic; Respiratory Sounds

To compare the efficacy of inhaled corticosteroids in infants and preschoolers with recurrent wheezing or asthma.. Randomized, prospective, controlled trials published January 1996 to March 2008 with a minimum of 4 weeks of inhaled corticosteroids versus placebo were retrieved through Medline, Embase, and Central databases. The primary outcome was wheezing/asthma exacerbations; secondary outcomes were withdrawal caused by wheezing/asthma exacerbations, changes in symptoms score, pulmonary function (peak expiratory flow and forced expiratory volume in 1 second), or albuterol use.. Of eighty-nine studies identified, 29 (N = 3592 subjects) met the criteria for inclusion. Patients who received inhaled corticosteroids had significantly less wheezing/asthma exacerbations than those on placebo (18.0% vs 32.1%); posthoc subgroup analysis suggests that this effect was higher in those with a diagnosis of asthma than wheeze but was independent of age (infants versus preschoolers), atopic condition, type of inhaled corticosteroid (budesonide metered-dose inhaler versus fluticasone metered-dose inhaler), mode of delivery (metered-dose inhaler versus nebulizer), and study quality (Jadad score: <4 vs >/=4) and duration (<12 vs >/=12 weeks). In addition, children treated with inhaled corticosteroids had significantly fewer withdrawals caused by wheezing/asthma exacerbations, less albuterol use, and more clinical and functional improvement than those on placebo.. Infants and preschoolers with recurrent wheezing or asthma had less wheezing/asthma exacerbations and improve their symptoms and lung function during treatment with inhaled corticosteroids.

Topics: Adrenal Cortex Hormones; Androstadienes; Asthma; Beclomethasone; Budesonide; Child, Preschool; Fluticasone; Humans; Infant; Lung Volume Measurements; Metered Dose Inhalers; Practice Guidelines as Topic; Randomized Controlled Trials as Topic; Respiratory Sounds; Secondary Prevention

The use of systemic corticosteroids, together with bronchodilators and oxygen therapy, has become established for the management of acute asthma. These agents are undoubtedly effective, but are also associated with problems such as metabolic adverse effects. Inhaled corticosteroids (ICS) offer potential benefit in the acute setting because they are delivered directly to the airways. They are also likely to reduce systemic exposure, which would lead in turn to reductions in rates of unwanted systemic effects. In order to evaluate the role of budesonide in the management of acute asthma exacerbations we conducted a review of the literature and critically evaluated the rationale for the use of ICS in general in this setting. Trials in adults and children requiring treatment for acute exacerbation of asthma have shown clinical and/or spirometric benefit for budesonide when delivered via nebulizer, dry powder inhaler, or aerosol in the emergency department, hospital and follow-up settings. The efficacy seems to benefit from high doses given repeatedly during the initial phase of an acute exacerbation. These acute effects are likely to be linked to the drug's distinctive pharmacokinetic and pharmacodynamic profile. The current evidence base revealed encouraging results regarding the efficacy of the ICS budesonide in patients with wheeze and acute worsening of asthma. Future studies should focus on the efficacy of these agents in more severe asthma worsenings.

Topics: Acute Disease; Administration, Inhalation; Adolescent; Adult; Asthma; Bronchodilator Agents; Budesonide; Child; Drug Administration Schedule; Emergencies; Glucocorticoids; Hospitalization; Humans; Respiratory Sounds; Treatment Outcome

Medications identified for the treatment of recurrent wheezing in preschool children by the Expert Panel Report of the NHLBI Guidelines for the Diagnosis and Management of Asthma include inhaled corticosteroids, chromones, theophylline, and leukotriene pathway modifiers. However, these various agents differ in their mechanism, extent of action on the airway inflammatory process, and degree of clinical efficacy. Inhaled corticosteroids can control symptoms in many young children with even severe persistent wheezing, but data on their long-term safety when administered in preschool-age children are scarce. There is some information on the uninterrupted use of inhaled corticosteroids in school-age children and the absence of an adverse effect on ultimate adult height. Despite laboratory evidence of adrenal suppression in some studies, few pediatric cases of clinical adrenal insufficiency have been reported. Low-dose inhaled corticosteroid (<400 mcg/day for beclomethasone), which is adequate for controlling mild persistent symptoms, is generally safe. Chromones have a remarkable safety profile, but they are most effective for symptoms of mild severity. Promising data have been published on the efficacy and safety of leukotriene pathway modifiers when used in young children with persistent symptoms. It is uncertain whether early introduction and long-term administration of inhaled corticosteroids prevent development of irreversible airway obstruction. Nevertheless, they may be especially useful for patients with moderate to severe disease in whom other agents (chromones or leukotriene pathway modifiers) will most likely fail to control symptoms. Pediatr Pulmonol. 2003; 35:241-252.

Topics: Anti-Inflammatory Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child, Preschool; Cromolyn Sodium; Glucocorticoids; Humans; Infant; Leukotriene Antagonists; Recurrence; Respiratory Sounds; Theophylline

To explore and compare the clinical control of three atomized inhalation budesonide (BUD) regimens for Chinese preschool children with recurrent wheezing using Test for Respiratory and Asthma Control (TRACK) scores. A total of 474 preschool children with positive Modified Asthma Predictive Index (mAPI) were randomly assigned to a daily group (initially given inhaled BUD 1 mg once a day and assessed every 4 weeks; if symptom were well controlled for 12 weeks, the dose was reduced to 25-50% of the previous dose until afinal dose of 0.25 mg once a day, maintained until 52 weeks), an intermittent high-dose group (1 mg twice daily for 7 days starting early during a predefined respiratory tract illness) and an intermittent medium-dose group (0.5 mg twice daily as soon as they contacted allergens or experienced nasal congestion, a runny nose, cough or other suspicious respiratory symptoms and continuing until symptoms were reduced or risk factors were absent for 3 days) for 52 weeks of treatment. The TRACK questionnaire was administered every 4 weeks. When TRACK scores were ≥ 80, symptoms were considered to be controlled. The average TRACK scores of the three groups after treatment were significantly higher than those before treatment (P < 0.001). There were no significant differences in the average TRACK scores and control rate after treatment at every 4 weeks in the three groups (P > 0.05). Te number of systemic glucocorticoid courses, urgent care visits for wheezing, and wheezing episodes before and after treatment were significantly different within each of the three groups (P < 0.001), but not among the three groups (P > 0.05). In clinical treatment of children, one of the three treatment options can be selected according to the specific situation case of mAPI- positive recurrent wheezing children.

Topics: Administration, Inhalation; Asthma; Budesonide; Child, Preschool; China; Glucocorticoids; Humans; Respiratory Sounds

Genetic variation may differentially modify drug and placebo treatment effects in randomized clinical trials. In asthma, although lung function and asthma control improvements are commonplace with placebo, pharmacogenomics of placebo vs. drug response remains unexamined. In a genomewide association study of subjective and objective outcomes with placebo treatment in Childhood Asthma Management Program of nedocromil/budesonide vs. placebo (N = 604), effect estimates for lead single nucleotide polymorphisms (SNPs) were compared across arms. The coughing/wheezing lead SNP, rs2392165 (β = 0.94; P = 1.10E-07) mapped to BBS9, a gene implicated in lung development that contains a lung function expression quantitative trait locus. The effect was attenuated with budesonide (P

Topics: Anti-Asthmatic Agents; Asthma; Budesonide; Child; Cough; Cytoskeletal Proteins; Female; Genome-Wide Association Study; Humans; Male; Microtubule-Associated Proteins; Nedocromil; Patient Reported Outcome Measures; Pharmacogenomic Testing; Placebo Effect; Polymorphism, Single Nucleotide; Respiratory Sounds; Treatment Outcome; Vital Capacity

The object of this study was to determine whether high doses of inhaled budesonide provide additional benefits to a standardized treatment regimen that includes systemic steroids and salbutamol in preschool patients presented to the emergency department (ED) with acute wheezing attacks. Methods This randomized, double-blind, placebo-controlled, parallel group trial was conducted in children, 6 months-6 years with moderate or severe acute wheezing epizode, as determined based on a pulmonary index score (PIS) of 7-13 points. We compared the addition of budesonide 3 mg versus placebo to standard acute asthma treatment, which included salbutamol and a single 1 mg/kg dose of methylprednisolone given at the beginning of therapy. The primary outcome was differences in hospitalization rates within 4 hr. Secondary outcome was difference in median PIS between treatment groups at 2 hr. Results One hundred patients were enrolled. Cumulative hospitalization rate at 120, 180, and 240 min were 0.72, 0.62, and 0.58 in placebo group; and 0.44, 0.30, and 0.24 in budesonide group. Discharged rate in budesonide group was significantly higher than the placebo group (log-rank = 12.407 ve P < 0.001). Expected mean discharged times were 200.4 (95%CI = 185.3-215.5) min in placebo group and 164.4 (95%CI = 149.4-179.4) min in budesonide group. Median (25-75%) PIS at the 120th min was significantly lower in budesonide group than the placebo group (5 [4-8] vs. 8 [5-9] respectively, P = 0.006). Conclusions The addition of budesonide nebulization may decrease the admission rate of preschool children who have moderate to severe acute wheezing epizodes. Pediatr Pulmonol. 2017;52:720-728. © 2017 Wiley Periodicals, Inc.

Topics: Acute Disease; Albuterol; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Double-Blind Method; Drug Therapy, Combination; Emergency Service, Hospital; Female; Hospitalization; Humans; Infant; Male; Methylprednisolone; Nebulizers and Vaporizers; Respiratory Sounds

To investigate the efficacy of fluticasone propionate aerosol (flixotide) versus budesonide suspension in the treatment of recurrent wheezing caused by bronchiolitis.. A total of 214 infants with newly diagnosed bronchiolitis were randomly divided into flixotide treatment (106 infants) and budesonide treatment groups (108 infants), and were given aerosol inhalation of flixotide or budesonide for 3 months after achieving remission of clinical symptoms. Another 136 infants with bronchiolitis who did not receive regular inhalation of corticosteroid after achieving remission of clinical symptoms were enrolled as the control group. The follow-up visits were performed for 1 year, and the effects of the two therapeutic methods on recurrent wheezing were evaluated.. Compared with the control group, both the flixotide and budesonide treatment groups had significantly fewer times of wheezing episodes within 1 year and a significantly lower recurrence rate of wheezing within the first 3 months after regular inhalation of corticosteroid, but no significant differences were observed between the two treatment groups. The amount of corticosteroid inhaled and hospital costs in the budesonide treatment group were significantly higher than in the flixotide treatment group (P<0.01).. Continuous inhalation of flixotide or budesonide after remission of clinical symptoms in children with bronchiolitis can reduce wheezing episodes and the recurrence of wheezing, and flixotide treatment is superior to budesonide treatment in the aspects of hospital costs and the amount of corticosteroid used.

Topics: Aerosols; Bronchiolitis; Budesonide; Female; Fluticasone; Humans; Infant; Male; Recurrence; Respiratory Sounds; Suspensions

Topics: Anti-Inflammatory Agents; Budesonide; Child, Preschool; Female; Humans; Infant; Male; Respiratory Sounds; Vitamin D Deficiency

Daily inhaled glucocorticoids are recommended for young children at risk for asthma exacerbations, as indicated by a positive value on the modified asthma predictive index (API) and an exacerbation in the preceding year, but concern remains about daily adherence and effects on growth. We compared daily therapy with intermittent therapy.. We studied 278 children between the ages of 12 and 53 months who had positive values on the modified API, recurrent wheezing episodes, and at least one exacerbation in the previous year but a low degree of impairment. Children were randomly assigned to receive a budesonide inhalation suspension for 1 year as either an intermittent high-dose regimen (1 mg twice daily for 7 days, starting early during a predefined respiratory tract illness) or a daily low-dose regimen (0.5 mg nightly) with corresponding placebos. The primary outcome was the frequency of exacerbations requiring oral glucocorticoid therapy.. The daily regimen of budesonide did not differ significantly from the intermittent regimen with respect to the frequency of exacerbations, with a rate per patient-year for the daily regimen of 0.97 (95% confidence interval [CI], 0.76 to 1.22) versus a rate of 0.95 (95% CI, 0.75 to 1.20) for the intermittent regimen (relative rate in the intermittent-regimen group, 0.99; 95% CI, 0.71 to 1.35; P=0.60). There were also no significant between-group differences in several other measures of asthma severity, including the time to the first exacerbation, or adverse events. The mean exposure to budesonide was 104 mg less with the intermittent regimen than with the daily regimen.. A daily low-dose regimen of budesonide was not superior to an intermittent high-dose regimen in reducing asthma exacerbations. Daily administration led to greater exposure to the drug at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; MIST ClinicalTrials.gov number, NCT00675584.).

Topics: Administration, Inhalation; Administration, Oral; Asthma; Bronchodilator Agents; Budesonide; Child, Preschool; Drug Administration Schedule; Female; Glucocorticoids; Humans; Infant; Male; Prednisolone; Respiratory Sounds; Severity of Illness Index; Treatment Failure

To compare the efficacy and adverse effects of aerosolized L-epinephrine vs budesonide in the treatment of post-extubation stridor.. Randomized controlled trial.. Pediatric intensive care unit (PICU) of a tertiary teaching and referral hospital.. Sixty two patients with a stridor score ?4 following extubation.. Patients were randomized to receive either aerosolized L-epinephrine (n=32) or budesonide (n =30). Respiratory rate, heart rate, stridor score, blood pressure and oxygen saturation were recorded from 0 min to 24 hours.. Stridor score remaining at >4, need for renebulization and reintubation between 20 min to 24 hours were primary outcome measures. Tachycardia (HR > normal for age), hypertension (BP >95th centile for age) and hypoxia (SpO2 < 92% for 5 min) were secondary outcome measures.. Both drugs showed a significant and comparable decline in the median (95% CI) stridor scores from baseline to 60 min [4 (4.10-4.50) to 2.00 (1.46-2.67) for budesonide vs 4 (4.12-5.00) to 2.00 (1.31 -2.75) for epinephrine]. At 2 hours, the stridor scores were significantly lower in the epinephrine as compared to budesonide group [0.00 (0.69-1.81) vs 3.00(1.75-3.32); P =0.02)]. However, the proportion of patients with stridor score >4 at any time between 20 min to 24 hrs (53.3% vs 53.1%; P=0.99), need for renebulization (40% vs 43.8%; P=0.76) and reintubation (20% vs 25%, P=0.638), and adverse effects were similar in both groups.. Both aerosolized L-epinephrine and budesonide were equally effective in their initial therapeutic response in post-extubation stridor. However, epinephrine showed a more sustained effect.

Topics: Administration, Inhalation; Aerosols; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Epinephrine; Female; Humans; Infant; Intubation, Intratracheal; Male; Respiration Disorders; Respiration, Artificial; Respiratory Sounds

Inhaled corticosteroids (ICS) are commonly used to treat wheezing disorders in children, but few studies have investigated the effect of ICS on lung function in infants. We evaluated the efficacy of inhaled budesonide for decreased specific airway conductance (sGaw) as an indication of bronchial obstruction in very young children with recurrent cough and/or wheeze. PATIENTS, DESIGN AND INTERVENTIONS: Functional residual capacity (FRC) and sGaw of steroid-naive children aged 3-26 months with respiratory symptoms were measured using an infant whole-body plethysmograph. Clinically indicated bronchoscopy was performed in 79% of the patients to exclude anatomical abnormalities before randomisation. Children with abnormal lung function and respiratory symptoms were randomised into two treatment groups, receiving either inhaled budesonide (400 microg/day) or placebo with NebuChamber for 6 weeks. Inhaled terbutaline 0.25 mg/dose was used as a rescue medication. Lung function measurements were repeated after 6 weeks.. Lung function.. 44 children with a median age of 11.3 months (range 3.7-25.9) completed the study. Median sGaw improved from a z score of -3.6 to -1.2 (p<0.001) in the budesonide group and from -3.2 to -2.6 (p = 0.033) in the placebo group; between group difference p = 0.014. Improvement in sGaw was more pronounced in children with atopy (p = 0.017). Symptom-free days increased in both the budesonide and placebo groups with no difference between groups.. Treatment with inhaled budesonide for 6 weeks improved sGaw in young children with chronic cough or wheeze and bronchial obstruction.

Topics: Administration, Oral; Airway Resistance; Bronchodilator Agents; Budesonide; Child, Preschool; Cough; Dyspnea; Female; Finland; Glucocorticoids; Humans; Infant; Lung; Male; Respiratory Sounds; Terbutaline; Treatment Outcome

To examine parent-reported signs and symptoms as antecedents of wheezing in preschool children with previous moderate to severe wheezing episodes, and to determine the predictive capacity of these symptom patterns for wheezing events.. Parents (n = 238) of children age 12 to 59 months with moderate-to-severe intermittent wheezing enrolled in a year-long clinical trial completed surveys that captured signs and symptoms at the start of a respiratory tract illness (RTI). Sensitivity, specificity, negative predictive value, and positive predictive value (PPV) for each symptom leading to wheezing during that RTI were calculated.. The most commonly reported first symptom categories during the first RTI were "nose symptoms" (41%), "significant cough" (29%), and "insignificant cough" (13%). The most reliable predictor of subsequent wheezing was significant cough, which had a specificity of 78% and a PPV of 74% for predicting wheezing.. Significant cough is the most reliable antecedent of wheezing during an RTI. It may be useful to consider individualized symptom patterns as a component of management plans intended to minimize wheezing episodes.

Topics: Acetates; Adult; Albuterol; Anti-Asthmatic Agents; Asthenia; Bronchodilator Agents; Budesonide; Causality; Child, Preschool; Cough; Cyclopropanes; Double-Blind Method; Female; Glucocorticoids; Humans; Infant; Male; Quinolines; Respiratory Sounds; Respiratory Tract Infections; Sensitivity and Specificity; Socioeconomic Factors; Sulfides; Surveys and Questionnaires

Acute wheezing illnesses in preschoolers require better management strategies to reduce morbidity.. We sought to examine the effectiveness of episodic use of an inhaled corticosteroid and a leukotriene receptor antagonist in preschoolers with intermittent wheezing.. In a randomized, double-blind, placebo-controlled 12-month trial, 238 children aged 12 to 59 months with moderate-to-severe intermittent wheezing received 7 days of either budesonide inhalation suspension (1 mg twice daily), montelukast (4 mg daily), or placebo in addition to albuterol with each identified respiratory tract illness (RTI). Proportion of episode-free days (EFDs) during the 12-month trial was the primary outcome.. The 3 treatment groups did not differ in proportions of EFDs, with adjusted mean EFDs of 76% (95% CI, 70% to 81%) for budesonide, 73% (95% CI, 66% to 79%) for montelukast, and 74% (95% CI, 65% to 81%) for conventional therapy (P = .66). The 3 groups did not differ in oral corticosteroid use, health care use, quality of life, or linear growth. However, during RTIs, budesonide and montelukast therapy led to modest reductions in trouble breathing (38% [P = .003] and 37% [P = .003], respectively) and interference with activity scores (32% [P = .01] and 40% [P = .001], respectively) that were most evident in those with positive asthma predictive indices.. In preschool children with moderate-to-severe intermittent wheezing, episodic use of either budesonide or montelukast early in RTIs, when added to albuterol, did not increase the proportion of EFDs or decrease oral corticosteroid use over a 12-month period. However, indicators of severity of acute illnesses were reduced, particularly in children with positive asthma predictive indices.

Topics: Acetates; Administration, Inhalation; Albuterol; Bronchodilator Agents; Budesonide; Child, Preschool; Cyclopropanes; Double-Blind Method; Female; Glucocorticoids; Humans; Infant; Leukotriene Antagonists; Male; Quinolines; Respiratory Sounds; Respiratory Tract Diseases; Sulfides

Inhaled corticosteroids (ICS) are preferred drugs for the long-term treatment of all severities of asthma in children. However, data about the safety of ICS in infants is lacking. So, it is essential to do further clinical studies to examine the safety and efficacy of ICS in this population. In this study, the effects of nebulized budesonide and nebulized fluticasone propionate suspensions on hypothalamic-pituitary-adrenal axis is examined in infants with recurrent or persistent wheeze. Thirty-one children aged 6-24 months admitted to our hospital between January and December 2005 with symptoms of recurrent or persistent wheeze were included in the study. The patients were randomly allocated to receive 0.25 mg BUD or 0.25 mg fluticasone propionate twice daily for 6 wk and half dose for another 6 wk with a jet nebulizer at home. Blood samples for basal cortisol concentration, adrenocarticotropic hormone, glucose, HbA1c and electrolytes were obtained at the beginning and at the end of the study. Adrenal function assessment was based on changes in cosyntropin-stimulated plasma cortisol levels. The study was completed with 31 patients, 16 of whom received BUD and 15 FP. All patients except one had plasma cortisol concentrations above 500 nmol/l (18 microg/dl) or had an incremental rise in cortisol of >200 nmol/l after stimulation. Although nebulized steroids seem to be safe in infancy, we recommend that adrenal functions should be tested periodically during long-term treatment with nebulized steroids.

Topics: Administration, Inhalation; Adrenocorticotropic Hormone; Androstadienes; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Budesonide; Child, Preschool; Female; Fluticasone; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Infant; Male; Nebulizers and Vaporizers; Pituitary-Adrenal System; Recurrence; Respiratory Sounds

We hypothesized that asthma is preceded by a stage of recurrent episodes of wheezing during the first years of life and that inhaled corticosteroid therapy during symptomatic episodes in this early phase may delay progression to persistent wheezing.. We assigned one-month-old infants to treatment with two-week courses of inhaled budesonide (400 mug per day) or placebo, initiated after a three-day episode of wheezing, in this single-center, randomized, double-blind, prospective study of three years' duration. The primary outcome was the number of symptom-free days; key secondary outcomes were the time to discontinuation due to persistent wheezing and safety, as evaluated by height and bone mineral density at the end of the study.. We enrolled 411 infants and randomly assigned 294 to receive budesonide at a first episode of wheezing. The proportion of symptom-free days was 83 percent in the budesonide group and 82 percent in the placebo group (absolute difference, 1 percent; 95 percent confidence interval, -4.8 to 6.9 percent). Twenty-four percent of children in the budesonide group had persistent wheezing, as compared with 21 percent in the placebo group (hazard ratio, 1.22; 95 percent confidence interval, 0.71 to 2.13)--a finding that was unaffected by the presence or absence of atopic dermatitis. The mean duration of the acute episodes was 10 days in both groups and was independent of respiratory viral status. Height and bone mineral density were not affected by treatment.. Intermittent inhaled corticosteroid therapy had no effect on the progression from episodic to persistent wheezing and no short-term benefit during episodes of wheezing in the first three years of life. (ClinicalTrials.gov number, NCT00234390.).

Topics: Administration, Inhalation; Asthma; Bronchodilator Agents; Budesonide; Disease Progression; Disease-Free Survival; Double-Blind Method; Drug Administration Schedule; Female; Humans; Infant; Male; Prospective Studies; Respiratory Sounds; Risk Factors; Treatment Failure

Although chronic obstructive pulmonary disease (COPD) patients frequently report symptoms, it is not known which factors determine the course of symptoms over time and if these differ according to the sex of the patient. The current study investigated predictors for presence, development and remission of COPD symptoms in 816 males and 312 females completing 3-yr-follow-up in the European Respiratory Society Study on Chronic Obstructive Pulmonary Disease (EUROSCOP). The following were included in generalised estimating equations logistic regression analyses: explanatory variables of treatment; pack-yrs smoking; age, forced expiratory volume in one second % predicted (FEV1 % pred); annual increase in FEV1 and number of cigarettes smoked; body mass index; and phadiatop. Interaction terms of sex multiplied by explanatory variables were tested. Over 3 yrs, similar proportions of males and females reported symptoms. In males only, higher FEV1 % pred was associated with reduction in new symptoms of wheeze and dyspnoea, and symptom prevalence was reduced with annual FEV1 improvement and phlegm prevalence reduced with budesonide treatment (odds ratio 0.66; 95% confidence interval 0.52-0.83). Additionally an increase in the number of cigarettes smoked between visits increased the risk of developing phlegm (1.40 (1.14-1.70)) and wheeze (1.24 (1.03-1.51)) in males but not females. The current study shows longitudinally that symptom reporting is similar by sex. The clinical course of chronic obstructive pulmonary disease can differ by sex, as males show greater response to cigarette exposure and treatment.

Topics: Adult; Aged; Body Mass Index; Bronchodilator Agents; Budesonide; Dyspnea; Europe; Female; Follow-Up Studies; Forced Expiratory Volume; Humans; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Remission Induction; Respiratory Sounds; Sex Factors; Smoking

To compare the safety of budesonide inhalation suspension (BIS) with placebo in infants 6 to 12 months of age with mild to moderate persistent asthma or recurrent wheeze.. In this multicenter, randomized, double-blinded, parallel-group, placebo-controlled study, 141 patients received 0.5 mg BIS (n = 48), 1.0 mg BIS (n = 44), or placebo (n = 49) once daily for 12 weeks. The primary variable was adrenal function, based on cosyntropin-stimulated plasma cortisol levels. Spontaneous adverse events and clinical laboratory findings also were monitored.. Overall, the types and frequencies of adverse events reported during the study were comparable across treatment groups. The response to cosyntropin stimulation was similar across treatment groups, with no significant difference between BIS treatment and placebo.. The safety profile of BIS was similar to that of placebo, with no suppressive effect on adrenal function in patients 6 to 12 months of age with mild to moderate persistent asthma or recurrent wheeze.

Topics: Administration, Inhalation; Adrenal Glands; Asthma; Bronchodilator Agents; Budesonide; Double-Blind Method; Drug Administration Schedule; Female; Humans; Hydrocortisone; Infant; Male; Nebulizers and Vaporizers; Respiratory Sounds

This study aimed at identifying in a daily-life setting the influence of facemask design on drug delivery via a spacer to young children. In a 4-week randomized crossover study, 24 children (7-23-months old) with recurrent wheeze tested the AstraZeneca, Galemed, and Hans Rudolph facemask combined with the NebuChamber at home. Each mask was tested twice daily for seven consecutive days. Filters positioned between the NebuChamber and facemask trapped the budesonide aerosol (200 microg, Pulmicort). Parents were asked to score the child's degree of cooperation during administration on diary cards. The administration procedure was evaluated through video recordings. Mean filter dose (standard deviation (s.d.)), expressed as % of nominal dose, was 39% (14), 47% (12), and 42% (11) for the AstraZeneca, the Galemed and the Hans Rudolph mask, respectively. Irrespective of the degree of cooperation, the Galemed mask gave significantly higher mean filter doses than the other masks (level of significance) (p < 0.045). Median (range) within-subject dose variability, expressed, as coefficient of variation (CV), was 37% (19-255), 32% (9-114), and 30% (9-115) for the AstraZeneca mask, the Galemed mask and the Hans Rudolph mask, respectively, not significant. Dose variability increased with decreasing cooperation for all three masks (p = 0.007). Drug delivery to young children with recurrent wheeze by means of the NebuChamber can be enhanced using the Galemed facemask. Dose variability seems to be independent of facemask design but mainly depends on cooperation.

Topics: Administration, Inhalation; Age Factors; Bronchodilator Agents; Budesonide; Cough; Cross-Over Studies; Dyspnea; Equipment Design; Female; Humans; Infant; Inhalation Spacers; Male; Masks; Metered Dose Inhalers; Respiratory Sounds

In order to affect the natural course of childhood wheezing and asthma, anti-inflammatory therapy is often prescribed for young wheezing children, but there is lack of long-term follow-up data.. Eighty-two of the original 100 children, hospitalized for wheezing under the age of 2 years in 1992-1993, were re-examined at school age in 1999. The children had participated in an open, randomized, parallel-group trial including a 4-month intervention with inhaled sodium cromoglycate (SCG) or budesonide (BUD). The baseline data, including data on atopy, eosinophilia and viral etiology, were prospectively collected on admission.. At early school age (median 7.2 years), asthma was present in 33 (40%) children. There was less asthma in the original SCG (21%) than in the control group (54%) (OR 0.23; 95% CI 0.07-0.77). The figure was 46% in the BUD group. When the analyses were performed separately for atopic and non-atopic infants, the difference was significant only among atopics. The lowered risk for asthma in the SCG group remained significant in the multivariate logistic regression analysis when adjusted for age, sex and atopy, and further when adjusted for earlier episodes of wheezing and respiratory syncytial virus identification. However, after adjustment for blood eosinophilia, the significance was lost, albeit the risk for asthma remained low (OR 0.21; 95% CI 0.04-1.12). A sensitivity analysis, which was done by including the six drop-outs of the SCG group as unfavorable and the 12 drop-outs of other groups as favorable outcomes in the model, did not change the direction of the result (OR 0.70; 95% CI 0.26-1.89).. An early SCG intervention in infants hospitalized for wheezing was associated with a lowered risk for early school-age asthma, especially in infants with evidence of atopy.

Topics: Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Child; Cromolyn Sodium; Follow-Up Studies; Humans; Infant; Respiratory Sounds; Treatment Outcome

The efficacy of different facemasks that can be used in the delivery of aerosol medication to children with recurrent wheeze or asthma was investigated. The results showed a statistically significant difference between some of the masks used, which has important implications for current clinical practice

Topics: Administration, Inhalation; Asthma; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Cross-Over Studies; Humans; Infant; Masks; Respiratory Sounds

There are no available data on the safety of recommended schedules for the initiation of treatment with budesonide inhalation suspension in children with recurrent wheezing episodes. We compared the safety of high and low starting dose of budesonide by measuring their effect on plasma cortisol concentration.. A randomized double-blind, placebo-controlled design was used. Twenty-nine children ages 6 months to 3 years were divided into three groups: (1) high starting dose: 1 mg budesonide inhalation suspension twice daily followed by a stepwise decrease of 25% every second day for 8 days (n = 11); (2) low starting dose: 0.25 mg twice daily for 8 days (n = 11); (3) placebo (n = 7). The 8 AM (fasting) and 1-hour post-ACTH stimulation plasma cortisol concentrations were measured before and 10 days after initiation of budesonide treatment.. Before treatment and after 8-10 days of treatment, there was no significant difference in mean serum cortisol concentration in the high starting dose, low-dose and placebo groups, either at 8 AM or at 1 hour after ACTH stimulation.. The administration of nebulized suspension of budesonide at a high starting dose (2 mg/day for 2 days) followed by a rapid stepwise decrease over 8 days was safe, causing similar changes in serum cortisol levels to low-dose budesonide suspension or placebo.

Topics: Administration, Inhalation; Asthma; Bronchodilator Agents; Budesonide; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Female; Humans; Hydrocortisone; Infant; Male; Nebulizers and Vaporizers; Recurrence; Respiratory Sounds; Safety; Time Factors

Inhaled corticosteroids are highly effective in the treatment of asthma at all ages, and their use in younger children is increasing. There are no data currently available on the treatment of infants with acute wheeze and dyspnea with nebulized budesonide.. Our purpose was to assess the clinical effect of nebulized budesonide in infants with acute wheeze and dyspnea.. A prospective study was performed comparing the addition of nebulized budesonide 0.25 mg every 6 hours (group A, n = 32) and nebulized ipratropium bromide 0.1 mg every 6 hours (group B, n = 39) with the normal treatment regimen with intravenous fluid, hydrocortisone, and nebulized fenoterol. A clinical score was made at admission and every 12 hours. The score included wheezing and costal retraction (0-6) and respiratory rate (counts per minute).. Seventy-one infants aged 3 to 24 months were studied (42 boys). A statistically significant reduction was seen in clinical score and respiratory rate in both groups 12 hours after admission. The children who received budesonide improved significantly faster than the children who received ipratropium bromide, and the hospitalization period was significantly lower in the budesonide group (66.4 hours) compared with the ipratropium bromide group (93 hours) (P <.01). Three patients from the budesonide group and 2 from the ipratropium bromide group were readmitted within the first 4 weeks.. Treatment of infants with acute wheeze with nebulized budesonide is associated with faster clinical improvement and reduction in hospital stay period.

Topics: Administration, Inhalation; Bronchodilator Agents; Budesonide; Child, Preschool; Drug Therapy, Combination; Dyspnea; Female; Fenoterol; Humans; Hydrocortisone; Infant; Injections, Intravenous; Ipratropium; Male; Respiratory Sounds; Therapeutic Equivalency

To evaluate the influence of early antiinflammatory therapy in the development of asthma 3 years after hospitalization for wheezing in infancy. In addition, the effects of allergic sensitization and respiratory syncytial virus (RSV) infection on the development of asthma were investigated.. A randomized, controlled follow-up study in a university hospital that provides primary hospital care for all pediatric patients in a defined area.. Eighty-nine infants under 2 years of age who had been hospitalized for infection associated with wheezing and followed up for 3 years.. Early antiinflammatory therapy was given for 16 weeks; 29 patients received cromolyn sodium and 31 received budesonide. Twenty-nine control patients received no therapy.. Clinical diagnosis of current asthma, defined as having at least 3 episodes of physician-diagnosed wheezing and either a wheezing episode during the preceding year or ongoing antiinflammatory medication for asthma.. Fourteen (48%) patients in the former cromolyn group, 15 (48%) in the former budesonide group, and 16 (55%) in the control group had current asthma. The significant predictors of asthma were age over 12 months (risk ratio [RR] 4.1; 95% confidence interval [CI] = 1.59-10.35), history of wheezing (RR 6.8; CI = 1.35-34.43), and atopic dermatitis on study entry (RR 3.4; CI = 1.17-9.39). Skin prick test positivity at the age of 16 months significantly predicted asthma (RR 9.5; CI = 2.45-36.72). In addition, all of the 18 (20%) children sensitized with furred pet developed asthma. RSV identification (RR 0.3; CI = 0.08-0.80) and early furred pet contact at home (RR 0.3; CI 0.10-0.79) were associated with the decreased occurrence of asthma.. Antiinflammatory therapy for 4 months has no influence on the occurrence of asthma 3 years after wheezing in infancy. Early sensitization to indoor allergens, especially to pets, and atopic dermatitis predict subsequent development of asthma. RSV infection in wheezing infants may have a better outcome than other infections.

Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Budesonide; Comorbidity; Cromolyn Sodium; Dermatitis, Atopic; Disease Progression; Female; Finland; Follow-Up Studies; Food Hypersensitivity; Hospitalization; Humans; Infant; Male; Prospective Studies; Respiratory Hypersensitivity; Respiratory Sounds; Respiratory Syncytial Virus Infections; Risk Factors

The aims of this study were to assess and compare dose delivery and dose variability of pressurized metered dose inhalers (pMDI)/spacers in wheezy infants in daily life and to investigate factors influencing aerosol delivery. In an open randomized crossover study in 25 wheezy infants aged 5-26 months, a metal spacer (Nebuchamber), a detergent coated (DC) and a non-detergent coated (nonDC) plastic spacer (Babyhaler) were tested at home for 7 days each. Budesonide (200 microg b.i.d) was administered via a Nebuchamber or fluticasone (125 microg b.i.d) via a Babyhaler. Aerosol was trapped in filters, positioned between the spacer and face mask. Cooperation was scored on diary cards. Electrostatic charge (ESC) of the spacers was measured. Evaluations of the administration technique were made from video recordings. Median (range) dose delivery of the filters expressed as per cent (%) of nominal dose, was 34% (3-59), 23% (1-49), and 41% (12-55) for the Nebuchamber, nonDC-Babyhaler, and DC-Babyhaler respectively. Considerable dose variability was found, median (range) within-subject dose variability, expressed as coefficient of variation, for the Nebuchamber (49% (15-249)) was significantly higher when compared with both nonDC- (36% (12-325)) and DC-Babyhalers (27% (10-122)), for which dose variabilities were similar. Detergent coating was effective to reduce electrostatic charge, and to increase dose delivery, but had no effect on dose variability. Bad cooperation was an important cause for high dose variability for all spacers (r=0.5-0.6, p<0.02). Many mistakes were made during the administration procedure.

Topics: Aerosols; Androstadienes; Anti-Asthmatic Agents; Bronchodilator Agents; Budesonide; Child, Preschool; Coated Materials, Biocompatible; Cross-Over Studies; Detergents; Electricity; Equipment Design; Fluticasone; Humans; Infant; Patient Compliance; Respiratory Sounds

Previous studies suggest that recurrent episodes of coughing and wheezing occur in up to 75% of infants after acute viral bronchiolitis.. To assess the efficacy of budesonide given by means of a metered dose inhaler, spacer, and face mask in reducing the incidence of coughing and wheezing episodes up to 12 months after acute viral bronchiolitis.. Children under the age of 12 months admitted to hospital with acute viral bronchiolitis were randomised to receive either budesonide or placebo (200 microg or one puff twice daily) for the next eight weeks. Parents kept a diary card record of all episodes of coughing and wheezing over the next 12 months.. Full follow up data were collected for 49 infants. There were no significant differences between the two study groups for the number of infants with symptom episodes up to six months after hospital discharge. At 12 months, 21 infants in the budesonide group had symptom episodes compared with 12 of 24 in the placebo group. The median number of symptom episodes was 2 (range, 0-13) in those who received budesonide and 1 (range, 0-11) in those who received placebo. Because there is no pharmacological explanation for these results, they are likely to be caused by a type 1 error, possibly exacerbated by there being more boys in the treatment group.. Routine administration of budesonide by means of a metered dose inhaler, spacer, and face mask system immediately after acute viral bronchiolitis cannot be recommended.

Topics: Acute Disease; Administration, Inhalation; Administration, Topical; Anti-Inflammatory Agents; Bronchiolitis, Viral; Bronchodilator Agents; Budesonide; Child, Preschool; Double-Blind Method; Female; Follow-Up Studies; Glucocorticoids; Humans; Infant; Infant, Newborn; Male; Nebulizers and Vaporizers; Respiratory Sounds

There are no data currently available on the correct schedule for the initiation of treatment with nebulized suspension of budesonide in children with recurrent wheezing episodes. We compared the efficacy and safety of starting with a high dose followed by a stepwise decrease to a continuous low dose.. In a double-blind design, 42 children aged 6 months to 3 years were randomly allocated to receive either a high starting dose of 1 mg budesonide twice daily followed by a stepwise decrease of 25% every second day for 1 week (group A) or a low dose of 0.25 mg twice daily for 1 week (group B). Efficacy was assessed with daily symptom scores and the systemic effect of the corticosteroids with the adrenocorticotropic hormone test.. The two groups were comparable for all parameters evaluated. During the first week of treatment, there was a significant decrease in asthmatic symptomatology only in group A: a 59% decrease for wheezing (p = 0.0001), 39% for diurnal cough (p = 0.036), and 39% for nocturnal cough (p = 0.04). Mean time to clinical response was 3.0 days in group A and 5.7 days in group B (p = 0.02). This early improvement was sustained for the rest of the follow-up period. The high dose starting schedule was not associated with any change in serum cortisol level.. The administration of nebulized suspension of budesonide at a high starting dose schedule followed by a rapid (1 week) stepwise decrease yields a significant early improvement in asthma symptoms and causes no change in serum cortisol levels.

Topics: Administration, Inhalation; Anti-Inflammatory Agents; Asthma; Budesonide; Child, Preschool; Double-Blind Method; Female; Follow-Up Studies; Humans; Infant; Male; Recurrence; Respiratory Sounds; Suspensions

To determine the effectiveness of nebulized budesonide in the treatment of acute bronchiolitis and in the prevention of postbronchiolitic wheezing.. A randomized, double-blind, placebo-controlled trial was performed.. Forty infants with bronchiolitis (83% RSV), mean age 13.5 weeks (range 4 to 41 weeks), were admitted to the Royal Alexandra Children's Hospital, Brighton, UK.. Twenty-one infants received nebulized budesonide 1 mg every 12 hours for 5 days, then 500 micrograms every 12 hours continuing to a total of 6 weeks. Nineteen received nebulized placebo (0.9% saline) for 6 weeks. A clinical scoring system was used to rate acute symptoms, and diary cards were used to assess persistent respiratory symptoms over a 6-month follow-up period.. No significant differences were found between the budesonide and placebo groups in change in clinical score 48 hours after trial entry, mean oxygen requirements, or length of hospital stay during the acute illness. At 6-month follow-up, the two groups did not differ significantly in prevalence of wheeze, respiratory symptom scores, or proportion requiring bronchodilators or steroids.. This study did not demonstrate that a 6-week course of nebulized budesonide reduced the symptoms of acute bronchiolitis or prevented postbronchiolitic wheezing.

Topics: Acute Disease; Bronchiolitis; Bronchodilator Agents; Budesonide; Double-Blind Method; Female; Humans; Infant; Infant, Newborn; Length of Stay; Male; Nebulizers and Vaporizers; Respiratory Sounds; Treatment Outcome

We investigated the 1-year outcome of children hospitalized for wheezing, paying special attention to the effect of early anti-inflammatory therapy. In addition, we identified risk factors for recurrent wheezing and asthma. Eighty-eight children under 2 years old treated in the hospital for wheezing were followed for 1 year. Nebulized anti-inflammatory therapy was given for 16 weeks: 31 patients received budesonide, 29 patients cromolyn sodium, and 28 control patients received no therapy. The number of subsequent physician-diagnosed wheezing episodes was recorded. Four months of anti-inflammatory therapy did not significantly decrease the occurrence of asthma 1 year later; 45% of patients in the cromolyn group, 42% in the budesonide group, and 61% in the control group had asthma, defined as at least two bronchial obstruction episodes during the 1-year period after the original hospitalization for wheezing. An age over 12 months at the time of the initial bronchial obstructing episode [P=0.009, risk ratio (RR)=5.4, 95% confidence interval (CI)=1.53-19.31], failure to identify a viral cause (P=0.0003, RR=12.0, CI=3.16-45.40), history of wheezing (P=0.02, RR=14.6, CI=1.59-132.10), the presence of atopy (P=0.01, RR=5.3, CI=1.47-19.21), a family history of atopy (P=0.03, RR=3.6, CI =1.15-11.12), and serum eosinophil cationic protein (ECP) > or = 16 microg/L (P=0.005) were significant risk factors for asthma. We conclude that early anti-inflammatory therapy for 4 months does not significantly decrease the occurrence of asthma during the period of 1 year following hospitalization for the original episode of wheezing. Young children requiring hospital admission for wheezing during a respiratory tract infection are at increased risk of having subsequent asthma if they have wheezed previously, if they have atopy or a family history of atopy, if they have elevated serum ECP, if they are over 12 months of age at the original bronchial obstructive episode, and especially when viral studies are negative.

Topics: Administration, Inhalation; Administration, Oral; Analysis of Variance; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Bronchi; Budesonide; Chi-Square Distribution; Child, Preschool; Cromolyn Sodium; Dermatitis, Atopic; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Hypersensitivity; Infant; Infant, Newborn; Logistic Models; Male; Prospective Studies; Recurrence; Respiratory Sounds; Risk Factors; Theophylline; Time Factors

We have evaluated the role of eosinophil cationic protein (ECP) concentrations in serum in predicting wheezing after bronchiolitis, during infancy and early childhood. A prospective study at a university hospital serving all pediatric patients in a defined area was designed. Serum ECP concentrations were measured in 92 infants under the age of 2 years on admission for acute bronchiolitis, and 6 and 16 weeks after hospitalization. Nebulized anti-inflammatory therapy was initiated during hospitalization: 32 patients received cromolyn sodium and 32 patients received budesonide for 16 weeks; 30 control patients received no maintenance therapy. The numbers of subsequent physician-diagnosed wheezing episodes and hospital admissions for obstructive airway disease were recorded during 16 weeks of follow-up. At entry, 14 of 92 (15%) children had high (> or = 16 micrograms/L) levels of ECP in their serum. During the 16-week follow-up period, this group of patients had significantly more physician-diagnosed episodes of wheezing (86% vs. 43%, P < 0.01) and hospital admissions for wheezing (64% vs. 19%, P = 0.001) than those with serum levels of ECP < 16 micrograms/L. The number of patients with serum ECP > or = 8 micrograms/L was 25 (27%); 76% of this group developed physician-diagnosed wheezing (P < 0.01), and 48% had hospital admissions for wheezing (P < 0.01). Serum ECP levels decreased significantly with respect to time after bronchiolitis and did not differ among the three intervention groups. We conclude that a high serum ECP concentration during the acute phase of bronchiolitis is a specific but insensitive predictor of wheezing after bronchiolitis.

Topics: Acute Disease; Analysis of Variance; Anti-Asthmatic Agents; Biomarkers; Blood Proteins; Bronchiolitis; Bronchodilator Agents; Budesonide; Child, Preschool; Cromolyn Sodium; Eosinophil Granule Proteins; Female; Follow-Up Studies; Humans; Infant; Inflammation Mediators; Male; Predictive Value of Tests; Pregnenediones; Prospective Studies; Respiratory Sounds; Ribonucleases; Sensitivity and Specificity

To evaluate whether early anti-inflammatory therapy with nebulized cromolyn sodium or budesonide reduces wheezing after bronchiolitis.. A randomized, controlled study in a university hospital that provides primary hospital care for all pediatric patients in a defined area.. One hundred consecutive infants younger than 24 months treated in the hospital for acute bronchiolitis.. Thirty-four patients received cromolyn sodium, 20 mg four times a day for 8 weeks and 20 mg three times a day for 8 weeks, and 34 patients received budesonide, 500 micrograms twice a day for 8 weeks and 250 micrograms twice a day for 8 weeks, by a foot pump with a face mask; 32 patients in the control group received no therapy.. Numbers of physician-diagnosed wheezing episodes, hospital admissions for bronchial obstructions, and symptomatic days recorded by the parents.. Children in the cromolyn sodium (19%) and budesonide (16%) groups had significantly fewer physician-diagnosed wheezing episodes than those in the control group (47%) during the second 8-week period (P < .05). A significant reduction in hospital admissions for bronchial obstructions was seen in the budesonide group and in the children with atopy in both treatment groups (P < .05). The children with atopy had significantly more subsequent wheezing episodes and hospital admissions than those without atopy (P < .05). The numbers of symptomatic days did not differ significantly among the three groups.. Early anti-inflammatory therapy with nebulized cromolyn sodium or budesonide reduces the number of wheezing episodes and hospital admissions after bronchiolitis. Children with atopy are at high risk of subsequent wheezing episodes, and they particularly benefit from anti-inflammatory therapy.

Topics: Administration, Inhalation; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Bronchiolitis; Bronchodilator Agents; Budesonide; Cromolyn Sodium; Humans; Infant; Pregnenediones; Prospective Studies; Respiratory Sounds; Risk Factors; Treatment Outcome

To determine the added clinical benefit of nebulized budesonide in children with mild to moderate croup treated with 0.6 mg/kg oral dexamethasone.. Randomized, double-blind, placebo-controlled trial.. Emergency department of a tertiary-care pediatric hospital with 47,000 visits per year.. Children 3 months to 5 years of age with a syndrome consisting of hoarseness, inspiratory stridor, and barking cough and a croup score of 3 or greater after at least 15 minutes of mist therapy. Patients were excluded from the study if they had diagnoses of epiglottitis, chronic upper or lower airway disease (not including asthma), or severe croup or had received corticosteroids within the preceding 2 weeks.. All patients received 0.6 mg/kg oral dexamethasone and were randomly assigned to receive 4 mL (2 mg) of budesonide solution (n=25) or 4 mL of 0.9% saline solution (n=25) by updraft nebulizer with a continuous flow of oxygen at 5 to 6 L/min.. The primary outcome measure was the proportion of patients in each group who had clinically important changes (two points) in the croup score during the 4 hours after treatment.. Eighty-four percent (n=21) of the patients who received budesonide had clinically important responses, compared with 56% (n=14) in the placebo group. The number of patients who would need to be treated with nebulized budesonide for one patient to have a clinically important response is four patients.. Despite receiving simultaneous oral dexamethasone, pediatric outpatients with mild to moderate croup have added, clinically important improvement in respiratory symptoms after treatment with budesonide.

Topics: Administration, Oral; Administration, Topical; Ambulatory Care; Anti-Inflammatory Agents; Bronchodilator Agents; Budesonide; Child, Preschool; Consciousness; Cough; Croup; Cyanosis; Dexamethasone; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Glucocorticoids; Heart Rate; Hoarseness; Humans; Infant; Male; Nebulizers and Vaporizers; Oxygen Inhalation Therapy; Pregnenediones; Pulmonary Ventilation; Respiration; Respiratory Sounds; Treatment Outcome

Acute episodic wheeze related to viral infections is a common and distressing condition and treatment remains unsatisfactory. Although some benefit from the continuous use of inhaled steroids has been demonstrated in young wheezy children, their effect primarily on acute episodes has not been considered. In this study the effect of budesonide (400 micrograms/day) was assessed in a four month double blind parallel trial, in 41 children (0.7-6.0 years) with predominantly episodic viral wheeze. Analysis of the last three months showed no difference between budesonide or placebo in mean daily total symptom score (median values 0.6 and 0.63), episode number (mean values 2.6 and 2.4), or score/episode (mean value 30 and 31). Four months of treatment with inhaled budesonide had no effect on acute episodes of wheeze in this group of children.

Topics: Acute Disease; Administration, Topical; Anti-Inflammatory Agents; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Female; Glucocorticoids; Humans; Infant; Infant, Newborn; Male; Pregnenediones; Respiratory Sounds; Virus Diseases

The short-term linear growth rate of the lower leg in toddlers was measured and evaluated in order to study the possible effect of inhaled budesonide on this factor in toddlers with mild recurrent wheezing. The short-term linear growth rate of the lower leg was measured weekly using a hand-held knemometer. Eighteen toddlers aged 13-36 months (mean 27 months) with a history of recurrent wheezing requiring inhaled topical steroids, but without need of regular medication during the months prior to the study, were studied. The children were randomized blindly through three consecutive treatment periods of four weeks with placebo or budesonide in daily doses of 200 micrograms and 800 micrograms administered as a pressurized aerosol inhaled via a spacer with a face mask. Twenty-nine percent (median) of the nominal dose was delivered at the mouth of the children. Three children were withdrawn because of exacerbations and one because of non-compliance. The precision of the measurement procedure was 51 microns/day. The mean growth rate during placebo, low-dose and high-dose steroid treatment was 92 microns/day, 114 microns/day and 46 microns/day respectively. The growth rate during the high-dose treatment was suppressed significantly compared to placebo treatment (95% CI -76 microns/day to -17 microns/day), whereas the growth rate during low-dose steroid treatment was indistinguishable from placebo treatment (95% CI -7 to +52 microns/day). In conclusion, measurement of short-term linear growth rate by knemometry in toddlers is a fast and gentle method with a high level of precision.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Inhalation; Administration, Topical; Anthropometry; Anti-Inflammatory Agents; Budesonide; Child, Preschool; Depression, Chemical; Dose-Response Relationship, Drug; Double-Blind Method; Glucocorticoids; Humans; Infant; Leg; Pregnenediones; Recurrence; Respiratory Sounds

The role of budesonide in controlling chest symptoms in infants was assessed. It was administered from a metered dose inhaler into a large volume spacer (Nebuhaler) with attached Laerdal mask. Twenty nine infants were recruited into a double blind crossover trial. Five defaulted. The remaining 24 (mean age 11 months) were assessed for the tolerance of the device, adverse effects, treatment failures, parental opinion, and daily symptom and treatment records. Twenty tolerated the modified Nebuhaler. One developed meningitis on placebo. Two experienced exacerbations on placebo. Eleven of 18 parents whose children completed the maximum treatment preferred budesonide to placebo and one preferred placebo. Mean symptom scores on budesonide were better than on placebo for the 15 children with complete symptom records. Fewer bronchodilator doses were used while taking budesonide. Our findings indicate that budesonide given in this way is an effective treatment for infants who may need prophylaxis for their wheezing.

Topics: Administration, Inhalation; Bronchodilator Agents; Budesonide; Double-Blind Method; Female; Humans; Infant; Male; Nebulizers and Vaporizers; Patient Satisfaction; Pregnenediones; Respiratory Sounds

77 children, aged 11 to 36 months (mean 24) with moderately severe recurrent wheezing, were treated with budesonide pressurised aerosol 400 micrograms twice daily or placebo for 12 weeks in a double-blind, parallel-group trial. Aerosols were inhaled from a spacer with a facemask. Budesonide significantly improved symptom scores of wheezing, sleep disturbance, and patient happiness. The frequency of severe exacerbations that required a course of oral prednisolone was also significantly reduced. The treatment effect appeared to be fully established after 6-8 weeks and no side-effects could be ascribed to the active treatment. The findings indicate that young children below 3 years of age can inhale a pressurised aerosol from a spacer with a facemask. Use of topically active glucocorticosteroids with this simple device may reduce symptoms and distress in young children with moderately severe recurrent wheeze and dyspnoea, and possibly reduce their requirement for oral steroids.

Topics: Administration, Inhalation; Administration, Oral; Aerosols; Budesonide; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Drug Evaluation; Female; Glucocorticoids; Humans; Infant; Male; Masks; Multicenter Studies as Topic; Pregnenediones; Randomized Controlled Trials as Topic; Recurrence; Respiratory Sounds; Time Factors

Serum periostin is a potential biomarker of response to therapies that target type 2 inflammation in asthma. The objectives of this study were to describe: 1) the distribution of serum periostin levels in adults with symptomatic airflow obstruction; 2) its relationship with other variables, including type 2 biomarkers; and 3) the effect of inhaled corticosteroids on periostin levels.Serum periostin levels were measured in a cross-sectional study exploring phenotypes and biomarkers in 386 patients aged 18-75 years who reported wheeze and breathlessness in the past 12 months. In 49 ICS-naïve patients, periostin levels were measured again after 12 weeks of budesonide (800 μg·day(-1)).The distribution of serum periostin levels was right skewed (mean±sd 57.3±18.6 ng·mL(-1), median (interquartile range) 54.0 (45.1-65.6) ng·mL(-1), range 15.0-164.7 ng·mL(-1)). Periostin was positively associated with exhaled nitric oxide (Spearman's rho=0.22, p<0.001), blood eosinophil count (Spearman's rho=0.21, p<0.001), and total IgE (Spearman's rho=0.14, p=0.007). The Hodges-Lehmann estimator (95% CI) of change in periostin level after ICS therapy was -4.8 (-6.7- -3.2) ng·mL(-1) (p<0.001).These findings provide data on the distribution of serum periostin in adults with symptomatic airflow obstruction, the weak associations between periostin and other type 2 markers, and the reduction in periostin with inhaled corticosteroid therapy.

Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Asthma; Budesonide; Cell Adhesion Molecules; Cross-Sectional Studies; Eosinophils; Exhalation; Female; Humans; Inflammation; Lung Diseases, Obstructive; Male; Middle Aged; New Zealand; Nitric Oxide; Respiratory Function Tests; Respiratory Sounds; Risk Factors; Surveys and Questionnaires; Young Adult

The aim of the study was to evaluate the association between previous use of ICS and bone mineral density (BMD) at school age in a cohort followed after early childhood wheezing.. As part of a prospective follow-up study after hospitalization for wheezing at <24 months of age, BMD was measured in 89 children at 12.3 (median) years of age. Data on ICS use were collected by interviewing the parents, and this was supplemented with data from patient records. Cumulative doses and the duration of ICS use were calculated. Areal BMD (BMDareal , g/cm(2) ) was measured by dual energy X-ray absorptiometry (DXA), and apparent volumetric BMD (aBMDvol , g/cm(3) ) was calculated, for the lumbar spine and femoral neck. Weight, height and pubertal stage were recorded.. Age, sex, and pubertal stage were significantly associated with BMDareal and aBMDvol of the lumbar spine and BMDareal of the femoral neck. The regular use of ICS for >6 months at age <6 years was associated with a lower BMD of the lumbar spine. A lower BMDareal and aBMDvol of the femoral neck were associated with higher cumulative doses of ICS at age 0-12.3 (median) years. The results were robust to adjustment for age, sex, pubertal stage, height, weight, and use of systemic steroids.. ICS use during childhood may be related to a decrease in BMD at late school age. It is important to use the lowest possible ICS dose that maintains adequate asthma control.

Topics: Absorptiometry, Photon; Administration, Inhalation; Age Factors; Bone Density; Budesonide; Child; Child, Preschool; Cohort Studies; Female; Femur Neck; Follow-Up Studies; Glucocorticoids; Humans; Lumbar Vertebrae; Male; Puberty; Respiratory Sounds; Sex Factors

Capsaicin causes direct irritation of the eyes, mucous membranes, and respiratory tract. It is used in self-defense, in crowd control, and as a less lethal weapon in police work. Controlled trials suggest that capsaicin has minimal serious acute effects. Herein, we report a woman who had a 20-minute exposure to capsaicin during a jail riot. She subsequently developed episodic dyspnea and cough, and increased sensitivity to scents, perfumes, and cigarette smoke. She has not had wheezes on physical examination or abnormal pulmonary function tests. Her response to inhaled steroids and long-acting beta-agonists has been incomplete. She appears to have developed airway sensory hyperreactivity syndrome after the inhalation of capsaicin, which likely injured sensory nerves and/or caused persistent neurogenic inflammation.

Topics: Bronchial Hyperreactivity; Bronchodilator Agents; Budesonide; Capsaicin; Cough; Dyspnea; Ethanolamines; Female; Formoterol Fumarate; Humans; Middle Aged; Respiratory Sounds

Relationships between early deficits of lung function, infant airway pathology and outcome in symptomatic infants are unclear. A study was undertaken to determine the associations between early lung function, airway histology and inflammation in symptomatic infants with the continuance of respiratory symptoms, lung function and subsequent use of inhaled asthma medication at the age of 3 years.. 53 children who underwent lung function measurements and bronchoscopy following referral to a specialist children's hospital for recurrent lower respiratory symptoms at a mean age of 1 year were followed up at 3 years of age. Assessments were made of respiratory symptoms during the previous year, lung function by oscillometry and atopy by skin prick testing. Individual data on the purchase of asthma medications were obtained from the Social Insurance Institution for the 12 months preceding the follow-up visit.. 50 children (94%) were re-evaluated, of whom 40 had ongoing airway symptoms. 11/39 (28%) who underwent successful oscillometry had reduced lung function, 31/50 (62%) used inhaled corticosteroids (ICS) regularly and 12/50 (24%) used ICS intermittently. Abnormal lung function at infancy was associated with ongoing airway symptoms (p<0.001) and with the purchase of ICS (p=0.009) and β agonists (p=0.002). Reticular basement membrane thickness in infancy and the numbers of mucosal mast cells, but not eosinophils, correlated significantly with the amount of ICS purchased at 3 years (p=0.003 and p=0.018, respectively).. Reduced lung function, thickening of the reticular basement membrane and increased density of mucosal mast cells in infancy are associated with respiratory morbidity and treatment needs at age 3 years in this highly selected group of children.

Topics: Airway Remodeling; Anti-Asthmatic Agents; Asthma; Basement Membrane; Biopsy; Bronchi; Bronchodilator Agents; Bronchoscopy; Budesonide; Female; Follow-Up Studies; Humans; Hypersensitivity, Immediate; Infant; Lung; Male; Prognosis; Respiratory Mucosa; Respiratory Sounds; Skin Tests

Topics: Albuterol; Asthma; Bronchodilator Agents; Budesonide; Cetirizine; Confined Spaces; Female; Histamine H1 Antagonists, Non-Sedating; Humans; Middle Aged; Prisoners; Respiratory Sounds; Spirometry; Tobacco Smoke Pollution

Topics: Budesonide; Child, Preschool; Croup; Dexamethasone; Diagnosis, Differential; Epinephrine; Glucocorticoids; Humans; Infant; Oxygen; Practice Guidelines as Topic; Respiratory Sounds; Severity of Illness Index

Topics: Acetates; Administration, Inhalation; Albuterol; Bronchodilator Agents; Budesonide; Child, Preschool; Cyclopropanes; Double-Blind Method; Female; Glucocorticoids; Humans; Infant; Leukotriene Antagonists; Male; Quinolines; Respiratory Sounds; Respiratory Tract Diseases; Sulfides

Pathological features of the airway in young children with severe recurrent wheeze suggest an association between bacterial colonization and the initiating events of early asthma. We conducted a study to investigate a possible association between bacterial colonization of the hypopharynx in asymptomatic neonates and later development of recurrent wheeze, asthma, and allergy during the first 5 years of life.. The subjects were children from the Copenhagen Prospective Study on Asthma in Childhood birth cohort who were born to mothers with asthma. Aspirates from the hypopharyngeal region of asymptomatic 1-month-old infants were cultured for Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus. Wheeze was monitored prospectively on diary cards during the first 5 years of life. Blood eosinophil count and total IgE and specific IgE were measured at 4 years of age. Lung function was measured and asthma was diagnosed at 5 years of age.. Hypopharyngeal samples were cultured from 321 neonates at 1 month of age. Twenty-one percent of the infants were colonized with S. pneumoniae, M. catarrhalis, H. influenzae, or a combination of these organisms; colonization with one or more of these organisms, but not colonization with S. aureus, was significantly associated with persistent wheeze (hazard ratio, 2.40; 95% confidence interval [CI], 1.45 to 3.99), acute severe exacerbation of wheeze (hazard ratio, 2.99; 95% CI, 1.66 to 5.39), and hospitalization for wheeze (hazard ratio, 3.85; 95% CI, 1.90 to 7.79). Blood eosinophil counts and total IgE at 4 years of age were significantly increased in children colonized neonatally with S. pneumoniae, M. catarrhalis, H. influenzae, or a combination of these organisms, but specific IgE was not significantly affected. The prevalence of asthma and the reversibility of airway resistance after beta2-agonist administration at 5 years of age were significantly increased in the children colonized neonatally with these organisms as compared with the children without such colonization (33% vs. 10% and 23% vs. 18%, respectively).. Neonates colonized in the hypopharyngeal region with S. pneumoniae, H. influenzae, or M. catarrhalis, or with a combination of these organisms, are at increased risk for recurrent wheeze and asthma early in life.

Topics: Asthma; Bacterial Infections; Bronchodilator Agents; Budesonide; Child, Preschool; Cohort Studies; Female; Haemophilus influenzae; Humans; Hypersensitivity; Hypopharynx; Immunoglobulin E; Infant; Infant, Newborn; Kaplan-Meier Estimate; Male; Moraxella catarrhalis; Neutrophils; Respiratory Sounds; Respiratory Tract Infections; Risk Factors; Staphylococcus aureus; Streptococcus pneumoniae

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Androstadienes; Asthma; Bronchodilator Agents; Budesonide; Child, Preschool; Environmental Exposure; Fluticasone; Humans; Infant; Respiratory Sounds

Topics: Administration, Inhalation; Androstadienes; Asthma; Bronchodilator Agents; Budesonide; Child, Preschool; Fluticasone; Humans; Infant; Nebulizers and Vaporizers; Particle Size; Respiratory Sounds

Topics: Administration, Inhalation; Asthma; Bronchiolitis; Bronchodilator Agents; Budesonide; Humans; Infant; Respiratory Sounds; Respiratory Syncytial Virus Infections

Subglottic laryngitis is one of the acute children's diseases, directly caused by a violently growing edema of the subglottic area. Its symptoms generally appear very suddenly, when children seem to be in perfect health, at night, several hours after falling asleep. Their symptoms included barking cough, clear voice, stridor, inspiratory dyspnoea with participation of auxiliary respiratory muscles, excitation and anxiety of a child, changes in skin coloration. The movement of the wings of the nostrils is intensified. In especially severe cases, agitation, cyanosis, pallor of skin, obnubilation, apnea, loss of consciousness and circulatory failure may also occur. Subglottic laryngitis is a disease, which can threaten the life of a small child. The aim of this study was to observe efficacy of the treatment of the subglottic laryngitis with glucocorticoids, especially budesonide in nebulization. The research covered 169 children: 58 girls (34.31%) and 111 boys (65.69%) aged 9. months do 5. years (mean 3 years 6 months) hospitalized in the Children's Hospital in Warsaw with the following symptoms: dry barking cough, stridor, inspiratory dyspnoea with the participation of auxiliary respiratory muscles, agitation and change of colour of skin. The examination of each patient included subjective, objective (pediatric and laryngological). Disease severity was assessed by a clinical croup score based on stridor, cough retractions, dyspnoea and cyanosis and the overall clinical assessment was scored on a visual scale. The results indicate that nebulised budesonide can be used as a safe and effective alternative treatment in children with moderate to severe subglottic laryngitis.

Topics: Administration, Inhalation; Budesonide; Child, Preschool; Cough; Cyanosis; Dyspnea; Female; Glucocorticoids; Humans; Infant; Laryngitis; Male; Respiratory Sounds; Severity of Illness Index; Treatment Outcome

Topics: Administration, Inhalation; Albuterol; Asthma, Exercise-Induced; Bronchodilator Agents; Budesonide; Child; Diagnosis, Differential; Dyspnea; Follow-Up Studies; Humans; Male; Respiratory Function Tests; Respiratory Sounds; Risk Assessment; Severity of Illness Index

Topics: Anti-Asthmatic Agents; Anti-Inflammatory Agents; Bronchiolitis; Bronchodilator Agents; Budesonide; Cromolyn Sodium; Humans; Infant; Pregnenediones; Respiratory Sounds

Topics: Acute Disease; Administration, Inhalation; Anti-Inflammatory Agents; Budesonide; Humans; Infant; Pregnenediones; Respiratory Sounds; Time Factors

Topics: Anti-Inflammatory Agents; Bronchiolitis; Budesonide; Drug Evaluation; Humans; Infant, Newborn; Nebulizers and Vaporizers; Pilot Projects; Pregnenediones; Recurrence; Respiratory Sounds

Three asthmatic children are reported with shortness of breath due to stridor. The stridor was preceded by a deterioration in asthma control necessitating the introduction or increased dosage of a pressurized beclomethasone inhaler. The stridor mimicked asthmatic symptoms and was only differentiated by auscultation directly over the neck and by response to nebulized adrenaline. One child had a laryngeal foreign body which probably gained entry via a pressurized inhaler.

Topics: Administration, Inhalation; Adolescent; Asthma; Budesonide; Child; Epinephrine; Foreign Bodies; Humans; Larynx; Male; Paint; Pregnenediones; Respiratory Sounds