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Albuterol aerosol versus albuterol Rotacaps in exercise-induced bronchospasm in children
E A Bronsky1, S L Spector, D S Pearlman
1AAAA Medical Research Group, Salt Lake City, UT 84102, USA.
Insights
Albuterol aerosol and powder effectively prevent exercise-induced bronchospasm in children with asthma. Both formulations were safe and superior to placebo in maintaining lung function after exercise.
Area of Science:
- Pediatric Pulmonology
- Pharmacology
- Clinical Trials
Background:
- Exercise-induced bronchospasm (EIB) is a common condition in children with asthma.
- Effective and safe preventive treatments are crucial for managing EIB and improving quality of life.
Purpose of the Study:
- To evaluate the safety and effectiveness of albuterol aerosol (180 mcg) and albuterol powder (200 mcg) in preventing EIB in children.
- To compare these albuterol formulations against a placebo.
Main Methods:
- A randomized, double-blind, three-way crossover study involving 46 children (aged 4-11 years) with asthma and EIB.
- Participants underwent an exercise challenge 15 minutes after receiving albuterol aerosol, albuterol powder, or placebo.
- Efficacy was measured by changes in FEV1 (forced expiratory volume in 1 second) and the percentage of patients protected from EIB.
Main Results:
- Both albuterol aerosol and powder significantly prevented EIB, with 91% and 95% of patients protected, respectively, compared to 57% with placebo.
- Mean postexercise FEV1 decreased only 6% with albuterol formulations versus a 23% decrease with placebo.
- No drug-related adverse events were reported, indicating a favorable safety profile for both albuterol formulations.
Conclusions:
- Albuterol aerosol and powder are safe and effective options for preventing exercise-induced bronchospasm in pediatric patients.
- Both inhaled albuterol formulations demonstrate superior efficacy compared to placebo in maintaining lung function during exercise challenges.
Abstract:
The purpose of this study was to determine the safety and effectiveness of albuterol aerosol 180 micrograms and albuterol powder 200 micrograms in the prevention of exercise-induced bronchospasm in children. Forty-six patients aged 4-11 years with asthma and exercise-induced bronchospasm were enrolled in this randomized, double-blind, single-dose, three-way crossover study comparing albuterol aerosol, albuterol powder, and placebo. Exercise challenge was performed at the screening visit for qualifying and baseline determinations of pulmonary function and then 15 min after drug administration at each of three visits. Prevention of exercise-induced bronchospasm was assessed by comparing across all treatment groups the percentage change in FEV1 from pre- to postexercise, the percentage of patients protected by treatment, postexercise minimum FEV1, and postexercise change in FEV1. Safety was assessed by observation of clinical adverse events, laboratory tests, physical examination, electrocardiogram and rhythm strips, vital signs, and pulmonary auscultation. Forty-four patients completed the study. Mean postexercise FEV1 decreased 6% from preexercise values when patients were treated with either albuterol formulation; FEV1 decreased 23% when patients were treated with placebo. Exercise-induced bronchospasm was prevented in 95% of patients when treated with albuterol powder, in 91% treated with albuterol aerosol, and in 57% treated with placebo. Patients maintained significantly higher mean minimum FEV1 values after treatment with albuterol powder and albuterol aerosol than when treated with placebo. Treatment with either albuterol formulation produced a significantly smaller decrease in mean FEV1 from pre- to postexercise than treatment with placebo. No drug-related adverse events were reported, and safety assessments were within normal limits.(ABSTRACT TRUNCATED AT 250 WORDS)