Nedocromil sodium for chronic asthma in children

Nedocromil (or Tilade) is a 'preventer' therapy used to treat chronic asthma in children. It is thought to be safer than inhaled steroids and can be used for the management of mild to moderate asthma. The review of studies including 15 trials and 1422 children found that there were some encouraging results in short term studies when nedocromil was compared on its own with placebo, particularly with regard to lung function tests. However, these results were not confirmed in one large, longer term study of four to six years duration, which did not show significant difference in the primary outcome of symptom free days. This study was conducted in children who had mild asthma. There may be a role for nedocromil in the management of moderate asthma, but it should be assessed in relation to inhaled steroids, whose efficacy is well-established. This particularly important in symptomatic asthma.

Authors' conclusions: 

A limited number of small studies have shown that nedocromil is of benefit in improving lung function and some measures of symptoms, but the evidence with regard to the primary outcome of the review was conflicting. Two long-term trials did not show consistent effects on lung function outcomes, whereas several small short-term trials have shown benefit in these outcomes. Differing severities at baseline may explain this difference with milder participants experiencing less benefit, although the discrepancy between study findings may also reflect publication bias. Nedocromil sodium is associated with a very good safety profile with no significant short term or long- term adverse side effects. Although nedocromil may have advantages over inhaled corticosteroids in terms of side effects, there is a need for head to head trials of nedocromil and inhaled corticosteroids to establish whether asthma control is similar, especially in mild asthma. It is not yet clear where nedocromil should sit in relation to other therapies in the treatment of asthma in children.

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Background: 

Currently inhaled corticosteroids are the main stay in the maintenance treatment of chronic asthma in children. Although inhaled corticosteroids play a crucial role in the management of childhood asthma, the long-term side effects of inhaled corticosteroids used in the management of chronic asthma in children are not clearly known.

Objectives: 

The objective of this review is to compare the safety and efficacy of inhaled nedocromil sodium with placebo in the treatment of chronic asthma in children.

Search strategy: 

We searched the Cochrane Airway Group trials register, review articles, and reference lists of articles. We also contacted the drug manufacturer and primary authors for additional citations. We also searched abstracts of major respiratory society meetings. The last search was carried out in November 2009.

Selection criteria: 

Randomised placebo controlled trials comparing nedocromil sodium to placebo in the treatment of chronic asthma in children (0 to 18 years).

Data collection and analysis: 

Both authors independently assessed trial quality and extracted data. Study authors were contacted for additional information.

Main results: 

Fifteen trials (twelve parallel group studies; three crossover trials recruiting 1422 children (837 males and 585 females)) were included. The studies were generally of good methodological quality. Two large long term studies used nedocromil for six months and four to six years and showed conflicting results in symptom free days. Short term studies (duration between 4 weeks to 12 weeks) showed that nedocromil sodium produced some improvement in a number of efficacy measures compared to placebo including FEV1, FVC, FEV1 % predicted, PC20 FEV1, evening PEF and symptom scores. The parent's assessment of efficacy was in favour of nedocromil (odds ratio (OR) 0.5 (95% CI 0.3 to 0.8). Nedocromil sodium has a good safety profile. The only significant side effect observed was unpleasant taste. There was little evidence for a clinically dose response effect and only a few studies recruited participants with severe asthma.

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