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Sample Topic: Asthma

Asthma : Last revised in December 2013

Evidence on inhaled corticosteroids

  • ICS versus placebo:
    • One systematic review (search date 1999, 12 randomized controlled trials [RCTs], n = 647) and seven subsequent RCTs (six RCTs, n = 1210; one RCT, n = 7241) involved budesonide. One systematic review (search date 2004, seven RCTs, n = 1043) involved fluticasone (100 or 200 micrograms/day). One systematic review (search date 2003, 10 RCTs, n = 1458) examined beclometasone and seven RCTs (n = 2788) examined triamcinolone, flunisolide, mometasone, and ciclesonide. All studies involved people with mild asthma and showed that ICS improved lung function, improved asthma symptoms, and reduced the need for bronchodilator therapy compared with placebo. Only the fluticasone systematic review showed that fluticasone significantly increased the risk of oral candidiasis compared with placebo (2% versus 0.5%; RR 3.45, 95% CI 1.29 to 9.26). The other reviews may have been underpowered to detect a clinically important difference [Rodolfo et al, 2005]
  • ICS versus short-acting beta2-agonist:
    • One systematic review (no search date, five RCTs [of which two compared beta2-agonists], n = 141) showed that ICS significantly improved lung function compared with beta2-agonists. No information was provided on adverse effects [Rodolfo et al, 2005].
  • ICS versus sodium cromoglicate:
    • A Cochrane review (search date February 2004) included 17 trials (n = 1279 children > 2 years of age) and eight trials (n = 321 adults) of people with moderate-to-severe asthma that made head-to-head comparisons of ICS against sodium cromoglicate. Inhaled corticosteroids were superior to sodium cromoglicate for all outcomes, such as reduced exacerbation rates (primary outcome), asthma symptom scores, peak flow rates, and need for rescue medication in children and adults (secondary outcomes). Adverse effects did not differ between groups, although inconsistent reporting and lack of long-term follow up prevent drawing firm conclusions about safety. The results are generalizable, but the studies did not involve infants younger than 2 years and older people (> 65 years) [Guevara et al, 2006].
  • ICS versus leukotriene receptor antagonists:
    • A systematic review (13 RCTs, 12 in adults, one in children) in people with mild-to-moderate asthma compared ICS (doses equivalent to beclometasone, 400 micrograms/day) with leukotriene receptor antagonists. Inhaled corticosteroids were more effective at reducing exacerbations, nocturnal awakenings, use of rescue beta2-agonists, and days with symptoms. Adverse effects did not differ between groups, but more people in the leukotriene receptor antagonist group withdrew because of poor asthma control [Ducharme, 2003]:
      • An RCT (n = 994) randomized children 6–14 years of age with mild persistent asthma to receive inhaled fluticasone, 100 micrograms twice daily, or oral montelukast, 5 mg once daily, for 1 year. The results favoured ICS over montelukast. The ICS group had more rescue-free days (mean 86.7% versus 84%); this result was statistically significantly in favour of fluticasone but is of questionable clinical significance. The fluticasone group had a lower proportion of children requiring systemic corticosteroids and a lower proportion with asthma attack [Garcia Garcia et al, 2005].
  • Fluticasone versus hydrofluoroalkane-134a (HFA)-beclometasone dipropionate:
    • A Cochrane review (search date January 2007) involving eight RCTs (n = 1260, only one study involving children) showed no statistically significant difference between both ICS on lung function over 6 to 12 weeks. However, this should not be taken as equivalence, as the data available could not exclude a meaningful benefit of fluticasone over HFA-beclometasone dipropionate. Data on exacerbation rates, symptom scores, and rescue medication use were very limited, but overall, no differences were reported. Adverse effects did not differ between groups, and very few adverse effects were recorded, which may due to the short duration of many of the studies. These findings cannot be generalized to children or people with a poor inhaler technique. Further research is needed to validate the effects reported in these studies [Lasserson et al, 2006].