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A double-blind study comparing the effectiveness of cromolyn sodium and sustained-release theophylline in childhood
Insights
Cromolyn sodium and theophylline are equally effective for childhood asthma. Cromolyn offers fewer side effects and may reduce bronchial hyperactivity, making it a beneficial option for mild to moderate cases.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
Background:
- Asthma is a common chronic respiratory disease in children.
- Managing childhood asthma involves balancing efficacy with safety and side effects.
Purpose of the Study:
- To compare the effectiveness and safety of cromolyn sodium versus theophylline (Theo-Dur) in treating mild to moderate asthma in children.
- To evaluate the impact of these medications on asthma symptoms, pulmonary function, and bronchial hyperresponsiveness.
Main Methods:
- A 3-month randomized trial involving 46 children (5-15 years) with asthma.
- Participants received either cromolyn or theophylline, with placebo controls.
- Methacholine challenge tests were conducted at baseline and at 3 months.
Main Results:
- Both theophylline and cromolyn groups showed significant improvements in symptom scores, pulmonary function, and reduced albuterol use.
- The theophylline group experienced more side effects and required more frequent office visits.
- Both treatments decreased methacholine sensitivity, with cromolyn showing a statistically significant improvement in one test.
Conclusions:
- Cromolyn sodium is as effective as theophylline for mild to moderate childhood asthma.
- Cromolyn offers advantages of fewer side effects and potential reduction in bronchial hyperactivity.
Abstract:
The effectiveness of cromolyn sodium and theophylline on asthma in children was compared during a 3-month trial. Forty-six children (aged 5 to 15 years) with asthma were assigned at random to cromolyn or theophylline (Theo-Dur) treatment groups. Each subject received theophylline placebo or cromolyn placebo in addition to the active drugs. A methacholine challenge test was done at the start of the study to document asthma and was repeated during the third month. The theophylline dosage was regulated to obtain serum levels of 10 to 15 micrograms/mL by a physician not involved directly with patient care. Forty patients completed the study. Both theophylline and cromolyn treatment groups showed improvement from base-line status in terms of symptom scores, pulmonary function, and decreased use of inhaled albuterol. Patients treated with theophylline had more side effects and required more frequent office visits than those treated with cromolyn. Both groups had decreased sensitivity to methacholine, and for one statistical test patients treated with cromolyn improved significantly. These results indicate that cromolyn is as effective as theophylline in treating mild to moderate asthma in children; additional benefits were fewer side effects and a possible decrease in bronchial hyperactivity.