ABSTRACT
BACKGROUND: Sequential administration of a beta-agonist and cromolyn or nedocromil before exercise is recommended for patients whose symptoms are not controlled by beta-agonists alone; however, this practice reduces compliance. OBJECTIVE: To evaluate the effectiveness of a new pre-combined aerosol formulation (salbutamol and nedocromil) in preventing exercise-induced bronchoconstriction and to compare it to salbutamol alone. METHODS: Twelve children with asthma were studied in a double-blind, double-dummy, randomized, crossover, placebo-controlled design to compare the protective effect of salbutamol and a new pre-combined salbutamol/nedocromil formulation against exercise-induced bronchoconstriction. The drugs were delivered by a metered-dose inhaler (salbutamol, 200 microg; salbutamol/nedocromil, 200 microg/4 mg; placebo, 2 puffs) 20 minutes before exercise. RESULTS: Both active drugs were significantly more protective than placebo but there was no difference between them. Complete protection was obtained in 12/12, 10/12, and 1/12 subjects for the salbutamol/nedocromil combination, salbutamol alone and placebo, respectively. CONCLUSIONS: Although inhaled beta-agonists alone are highly efficacious in preventing exercise-induced bronchoconstriction, a minority of patients exists for whom a combined treatment with salbutamol and nedocromil is advantageous. This group may represent a subpopulation of subjects who release more, or different, mediators in response to exercise.
Subject(s)
Adrenergic beta-Agonists/therapeutic use , Albuterol/therapeutic use , Anti-Asthmatic Agents/therapeutic use , Asthma, Exercise-Induced/prevention & control , Nedocromil/therapeutic use , Adolescent , Adrenergic beta-Agonists/administration & dosage , Albuterol/administration & dosage , Anti-Asthmatic Agents/administration & dosage , Bronchoconstriction/drug effects , Child , Cross-Over Studies , Double-Blind Method , Drug Combinations , Female , Forced Expiratory Volume , Humans , Male , Nebulizers and Vaporizers , Nedocromil/administration & dosageABSTRACT
Since the optimal dose of salmeterol in asthmatic children has not yet been clearly defined, we compared the efficacy and duration of the protective effect of two doses of salmeterol (25 and 50 micrograms) against exercise-induced bronchoconstriction. Twelve children (aged 7-14 yrs) with asthma were studied in a double-blind, cross-over, placebo-controlled design. On three separate days, exercise tests were performed 1 h and 12 h after administration of the drug. Pulmonary function measurements were performed before drug inhalation, before every exercise test and 1, 5, 10, 15 and 30 min after the end of exercise. The response was expressed as maximal decrease in forced expiratory volume in one second (FEV1). Both doses of salmeterol provided significant bronchodilation for up to 12 h, with no difference between them. Maximal exercise-induced decrease in FEV1 (% fall) 1 h after pretreatment was (mean +/- SD) 35 +/- 16, 10 +/- 10 and 4 +/- 3% for placebo, 25 and 50 micrograms salmeterol, respectively. At 12 h after pretreatment these values were 31 +/- 14, 19 +/- 12 and 15 +/- 13%, respectively. Individual protection against exercise-induced bronchoconstriction at 1 and 12 h did not vary between the dosages (p < 0.05), even though the protection obtained by 25 micrograms at 12 h was no longer significant versus placebo. We conclude that 25 micrograms of inhaled salmeterol provides equally effective long-lasting bronchodilation and acute protection against exercise-induced bronchoconstriction as 50 micrograms, and may be a suitable dose for most asthmatic children.
Subject(s)
Albuterol/analogs & derivatives , Asthma, Exercise-Induced/drug therapy , Asthma/drug therapy , Bronchoconstriction/drug effects , Bronchodilator Agents/administration & dosage , Administration, Inhalation , Adolescent , Albuterol/administration & dosage , Asthma/physiopathology , Asthma, Exercise-Induced/physiopathology , Child , Cross-Over Studies , Dose-Response Relationship, Drug , Double-Blind Method , Exercise Test , Female , Follow-Up Studies , Forced Expiratory Volume/drug effects , Humans , Male , Placebos , Salmeterol XinafoateABSTRACT
The role of nebulized flunisolide solution in controlling recurrent respiratory symptoms was assessed in a double-blind placebo-controlled parallel study on 23 infants and small children (mean age, 14.2 months) with bronchial asthma. Five of the 12 children in the placebo group and 1 of the 11 patients on active treatment had to be withdrawn from the study. Flunisolide significantly improved symptom scores of wheezing and cough. The rescue treatments with salbutamol did not differ between the two groups during the study. Parents considered the active treatment effective in all the patients, while the placebo was considered useful in 4 of 7 children. No side effects were detected with either treatments. This study indicates that nebulized flunisolide may be an effective treatment for infants with recurrent wheezing and cough.
Subject(s)
Anti-Inflammatory Agents/administration & dosage , Asthma/drug therapy , Fluocinolone Acetonide/analogs & derivatives , Airway Resistance/drug effects , Albuterol/administration & dosage , Albuterol/adverse effects , Anti-Inflammatory Agents/adverse effects , Bronchodilator Agents/administration & dosage , Bronchodilator Agents/adverse effects , Child, Preschool , Double-Blind Method , Female , Fluocinolone Acetonide/administration & dosage , Fluocinolone Acetonide/adverse effects , Humans , Infant , Ipratropium/administration & dosage , Ipratropium/adverse effects , Male , Nebulizers and Vaporizers , Treatment OutcomeABSTRACT
Cromolyn sodium (10 mg), nedocromil sodium (4 mg), and placebo, all delivered by a metered dose inhaler, were compared in their efficacy and duration of action in preventing exercise-induced asthma in children. After a screening test was performed, 13 patients with asthma performed standard exercise tests 20 minutes and 140 minutes after drug inhalation in a randomized, double-blind, crossover study. Both drugs were significantly more protective than placebo after 20 minutes, but no significant difference was seen between cromolyn sodium and nedocromil sodium. No difference between active drugs and placebo was found 140 minutes after inhalation. At these clinically recommended doses both cromolyn sodium and nedocromil sodium provide equal protection against exercise-induced asthma, and the duration of action of both lasts for less than 2 hours.
Subject(s)
Asthma, Exercise-Induced/prevention & control , Cromolyn Sodium/therapeutic use , Nedocromil/therapeutic use , Adolescent , Child , Cross-Over Studies , Double-Blind Method , Female , Forced Expiratory Volume/drug effects , Humans , Male , Time FactorsABSTRACT
Seventeen children with asthma were studied in a double-blind, crossover, placebo-controlled study designed to compare the efficacy of cromolyn sodium with that of nedocromil sodium in preventing exercise-induced asthma. All drugs were delivered through a metered-dose inhaler (cromolyn sodium, 10 mg; nedocromil sodium, 4 mg; placebo, two puffs). Nedocromil sodium and cromolyn sodium provided significant, comparable protection from exercise-induced asthma, and both drugs were better than placebo. We conclude that nedocromil sodium and cromolyn sodium administered by a pressurized aerosol provide equal protection against exercise-induced asthma in children.
Subject(s)
Asthma, Exercise-Induced/drug therapy , Cromolyn Sodium/therapeutic use , Nedocromil/therapeutic use , Adolescent , Asthma, Exercise-Induced/physiopathology , Child , Cross-Over Studies , Double-Blind Method , Female , Forced Expiratory Volume , Humans , Male , Nebulizers and VaporizersABSTRACT
To compare the effectiveness of cromolyn sodium (CS) (10 mg) and nedocromil sodium (NS) (4 mg) administered by a metered dose inhaler (MDI) with a spacer device in preventing exercise-induced asthma (EIA), eight asthmatic children with EIA were studied in a randomized double-blind, cross-over, placebo-controlled study, CS and NS provided significant, comparable protection from EIA and both were better than placebo. We conclude that CS and NS administered by a pressurized aerosol with a spacer device provide equal protection against EIA in children.
