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Double blind, placebo controlled study of nedocromil sodium in asthma
Insights
Nedocromil sodium significantly improved asthma control in children, reducing symptom scores and enhancing pulmonary function compared to placebo. This asthma medication was found to be safe and effective for pediatric patients.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
Background:
- Asthma is a chronic respiratory disease affecting millions of children worldwide.
- Effective long-term management strategies are crucial for improving quality of life and reducing exacerbations.
Purpose of the Study:
- To evaluate the efficacy and safety of nedocromil sodium in pediatric asthma patients.
- To compare nedocromil sodium treatment against a placebo in children with persistent asthma.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 209 asthmatic children aged 6-17 years.
- Participants received either 4 mg nedocromil sodium or placebo four times daily for 12 weeks, alongside their existing treatments.
- Data collected included daily symptom diaries, clinic assessments, pulmonary function tests, and bronchodilator usage.
Main Results:
- Nedocromil sodium demonstrated statistically significant improvements in clinician-assessed asthma severity and symptom scores.
- Patients in the nedocromil sodium group showed a 50% decrease in total symptom scores during the final four weeks, versus 9% in the placebo group.
- Improved pulmonary function and reduced need for inhaled beta-2 bronchodilators were observed with nedocromil sodium.
Conclusions:
- Nedocromil sodium is an effective treatment for managing asthma in children.
- The medication was well-tolerated, with a favorable safety profile, and considered effective by a majority of children, parents, and clinicians.
Abstract:
After a two week baseline, 209 asthmatic children (mean age 10 years, range 6-17) were randomly allocated to receive 4 mg nedocromil sodium (n = 110) or placebo (n = 99) four times daily for 12 weeks in addition to their current treatment. The children completed daily diary cards and visited the clinic at four week intervals. Statistically significant differences in favour of nedocromil sodium were seen for clinician assessment of asthma severity and diary card symptom scores, pulmonary function and inhaled beta 2 bronchodilator use. Total symptom score decreased by 50% from baseline in the nedocromil sodium group and by 9% in the placebo group during the final four weeks. Nedocromil sodium was considered very or moderately effective by 78% of children/parents (placebo 59%) and 73% of clinicians (placebo 50%). Nausea, headache and sleepiness, and dyspnoea led to withdrawal of one child from nedocromil sodium and placebo treatments, respectively. Reports of sore throat and headache were marginally greater with the nedocromil sodium treatment. It is concluded that nedocromil sodium was both effective and safe in the treatment of asthma in children.