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Nebulised sodium cromoglycate in the treatment of wheezy bronchitis. A multicentre double-blind placebo controlled
Insights
Nebulized sodium cromoglycate (SCG) did not effectively treat wheezy bronchitis in young children. This study found SCG was not superior to placebo in reducing symptoms or healthcare use for pediatric wheezing illnesses.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Allergy and Immunology
Background:
- Wheezy bronchitis is a common respiratory condition in children aged 1-4 years.
- Prophylactic treatments aim to reduce the frequency and severity of wheezing episodes.
- Sodium cromoglycate (SCG) is an established mast cell stabilizer with potential anti-inflammatory properties.
Purpose of the Study:
- To evaluate the efficacy of nebulised sodium cromoglycate (SCG) as a prophylactic treatment for wheezy bronchitis in children aged 1 to 4 years.
- To compare SCG's effectiveness against a placebo in reducing respiratory symptoms and healthcare utilization.
- To assess the impact of SCG on sleep disturbance and the need for supportive medications.
Main Methods:
- A multicentre, double-blind, placebo-controlled, group comparative study.
- Fifty-four children (aged 1-4 years) with wheezy bronchitis participated.
- Patients received either nebulised SCG or placebo for 10 weeks after a 4-8 week baseline period.
Main Results:
- Nebulised SCG showed no significant superiority over placebo in reducing day wheezing or coughing.
- Sleep disturbances due to wheezing or coughing at night were not significantly improved by SCG.
- No significant differences were observed in the use of supportive medications (beta 2-agonists, theophylline), doctor visits, or hospital admissions between the SCG and placebo groups.
Conclusions:
- Nebulised sodium cromoglycate (SCG) is not an effective prophylactic treatment for wheezy bronchitis in children aged 1-4 years.
- SCG did not demonstrate significant benefits over placebo in symptom reduction or decreased healthcare resource utilization.
- Further research may be needed to explore alternative prophylactic strategies for pediatric wheezing illnesses.
Abstract:
The efficacy of nebulised sodium cromoglycate (SCG) used as a prophylactic treatment of wheezy bronchitis in children aged 1 to 4 years was evaluated in a multicentre double-blind placebo controlled, group comparative study. Fifty-four patients completed the 10-week trial (29 treated with SCG and 25 treated with placebo), preceded by 4-8 weeks baseline. Nebulised SCG did not prove significantly superior to placebo in reducing day wheezing, day coughing, or sleep disturbance due to wheezing or coughing at night. Neither was there significant difference in the use of supportive medicine (beta 2-agonist and theophylline) between the groups. Extra doctor visits, hospital admissions, and parental preference did not show significant difference either.