pulmicort and Bronchial-Spasm

A multi-center, double-blind, randomized dose-response study was performed to assess the effect of 3 months of treatment with two different doses of inhaled nebulized budesonide in children with acute recurrent bronchial obstruction (BO) causing hospitalization. Steroid-naive children younger than 18 months were included when admitted to hospital because of BO for at least the second time, and were followed-up monthly for 15 months. Forty-five of 49 subjects (43 boys, 2 girls) (mean age 9.3 months upon inclusion) completed the study. Twenty-four patients (20 boys, 4 girls) received nebulized budesonide 0.5 mg twice daily for 1 month followed by 0.25 mg daily for the next 2 months, whereas 25 children received 0.1 mg twice daily throughout the 3-month treatment period. Outcome (number of BO episodes, time to first BO after start of treatment, and use of rescue medication), as well as height/length and weight, were assessed at the start of treatment and monthly for the following 3 months, as well as for 12 months after cessation of treatment (15 months in total). There was an overall tendency towards better symptom control (fewer episodes of acute BO during treatment and follow-up, fewer hospital visits because of acute BO, lower clinical score during follow-up, and less use of rescue medication during follow-up) in the high-dose treatment group vs. the low-dose treatment group. However, the differences did not reach statistical significance for any of the outcomes. The only significant difference in effect between the groups was fewer children in the high-dose group treated openly with nebulized budesonide during follow-up. Length/height and weight gain did not differ significantly between the two treatment groups throughout the study. There was no significant dose-dependent beneficial effect of 3 months of treatment with nebulized budesonide in infants and toddlers with at least two hospitalizations for acute bronchial obstruction.

Topics: Administration, Inhalation; Bronchial Spasm; Bronchodilator Agents; Budesonide; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Hospitalization; Humans; Infant; Infant, Newborn; Male; Nebulizers and Vaporizers; Recurrence; Treatment Outcome

Optimal management of chronic, mild-to-moderate asthma with inhaled steroids may include use of the lowest possible doses, as recommended in guidelines, and a reduction in the frequency of daily administration for greater convenience. Lower doses and once daily treatment with inhaled steroids must be rigorously evaluated in controlled clinical trials.. The objective of this study was to assess the efficacy and safety of once daily treatment with budesonide in subjects with stable asthma.. Once daily budesonide was assessed in 309 adult subjects, including those who were and were not using an inhaled steroid at baseline. The subjects were stratified by inhaled steroid use and randomly assigned to one of 3 treatments: 200 microgram budesonide, 400 microgram budesonide, or placebo administered by means of Turbuhaler once daily in the morning for 6 weeks. Beyond this point, treatment was continued unchanged for another 12 weeks (maintenance) in those receiving 200 microgram budesonide once daily and placebo. In those who received 400 microgram budesonide once daily, the dose was reduced to 200 microgram once daily at week 6 and held constant for the remaining 12 weeks (400/200 microgram group). Primary efficacy endpoints were mean change from baseline in FEV1 and morning peak expiratory flow.. Once daily budesonide was well tolerated and resulted in significant improvements in all efficacy endpoints, even though baselines were well stabilized. Baseline lung function was elevated with little room for improvement; however, mean increases in FEV1 during the maintenance period were 0.10 L and 0.11 L in the 200 microgram and 400/200 microgram groups, respectively, versus a decrease of -0.09 L in the placebo arm (P <.001). Results for peak expiratory flow were similar. Significant improvements in secondary endpoints, including symptoms, beta-agonist use, and quality of life, also developed with budesonide 200 and 400 microgram once daily.. Inhaled budesonide, in doses as low as 200 microgram, may be an appropriate introductory or maintenance dose in subjects with stable, mild-to-moderate asthma.

Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Anti-Inflammatory Agents; Asthma; Bronchial Spasm; Budesonide; Dose-Response Relationship, Drug; Double-Blind Method; Female; Headache; Humans; Male; Middle Aged; Quality of Life; Respiratory Function Tests; Respiratory Tract Infections

Nebulized budesonide and nebulized adrenaline have been shown to be effective in the treatment of moderately severe croup. However, there has been no direct comparison of these therapies. We undertook a multicenter, randomized, double-blind, parallel group study in 66 hospitalized children with viral or spasmodic croup.. Children 0.5 to 6 years of age were assessed using a validated croup symptom score (stridor, 0 through 4; cough, 0 through 3; retractions, 0 through 3; dyspnea, 0 through 3; and color, 0 through 4) at 0.5, 1, 1.5, 2, 12, and 24 hours after nebulization. Patients received either budesonide (2 mg/4 mL) or L-adrenaline (4 mg/4 mL) via nebulization. The primary outcome measure was change in the total croup symptom score.. Thirty-five children received budesonide and 31 received adrenaline. There was no significant difference in baseline features, including croup score (mean [95% confidence interval]: budesonide, 7.1 [6.7-7.5]; adrenaline, 7.7 [7.3-8.1]). All patients had significant improvement from baseline, and there was not significant difference between the two treatments, as measured by change in croup scores, change in oxygen saturation, duration of hospitalization, number of subsequent treatments with systemic steroids or adrenaline, and adverse events. No child required intubation.. This study does not show any difference in efficacy and safety between nebulized budesonide and nebulized adrenaline in the treatment of acute upper airway obstruction in patients with moderately severe croup.

Topics: Administration, Topical; Adrenergic Agonists; Aerosols; Airway Obstruction; Anti-Inflammatory Agents; Bronchial Spasm; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Croup; Double-Blind Method; Epinephrine; Glucocorticoids; Hospitalization; Humans; Infant; Intubation, Intratracheal; Length of Stay; Nebulizers and Vaporizers; Oxygen; Pregnenediones; Treatment Outcome

Topics: Adolescent; Adult; Aerosols; Asthma; Bronchial Spasm; Bronchodilator Agents; Budesonide; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Pregnenediones; Treatment Outcome

Topics: Acute Disease; Anti-Inflammatory Agents; Asthma; Bronchial Spasm; Budesonide; Child; Child, Preschool; Female; Humans; Male; Nebulizers and Vaporizers; Pregnenediones

Groups of guinea pigs sensitized with ovalbumin were treated with budesonide and beclomethasone dipropionate, respectively, in an intraperitoneal dose of 50 mg/kg. 20 h later, the anaphylactic release of histamine and slow reacting substance of anaphylaxis (SRS-A) from chopped lung tissue was studied. Whereas the corticosteroids studied had no effect on the tissue content of histamine or on the amount of antigen-induced release of this autacoid, budesonide and beclomethasone dipropionate to a great extent inhibited the release of SRS-A. The anti-anaphylactic effect of budesonide and beclomethasone was also shown in sensitized guinea pigs pretreated with mepyramine, 2.5 mg/kg intraperitoneally, and challenged with nebulized ovalbumin. We suggest that the partial protection given by the corticosteroids budesonide and beclomethasone dipropionate is due to the inhibiton of SRS-A release.

Topics: Anaphylaxis; Animals; Beclomethasone; Bronchial Spasm; Budesonide; Female; Glucocorticoids; Guinea Pigs; Histamine Release; Immunization; Male; Pregnenediones; Respiratory Tract Diseases; SRS-A