What randomized, controlled trials have been conducted on the use of inhaled corticosteroids in the treatment of asthma?

Updated: Nov 20, 2020
  • Author: Michael J Morris, MD, FACP, FCCP; Chief Editor: Zab Mosenifar, MD, FACP, FCCP  more...
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In a study by Peters et al, the use of the anticholinergic agent tiotropium in 210 asthmatic patients resulted in a superior outcome compared with a doubling of the dose of an inhaled glucocorticoid, as assessed by measuring the morning peak expiratory flow and other secondary outcomes. The addition of tiotropium in this study was also shown to be noninferior to the addition of salmeterol. [114]

Kerstjens et al evaluated 912 patients already taking an ICS/LABA combination who were randomized to 48 weeks of tiotropium versus placebo in two replicate, randomized, controlled trials. The patients had a mean baseline FEV1 of 62% of the predicted value. The use of tiotropium compared to placebo increased the time to first exacerbation (282 versus 226 days) and resulted in a higher peak change in FEV1 from baseline of 86 ± 34 mL (Trial 1) and 154 ± 32 mL (Trial 2) for those patients taking tiotropium. [115]

In a cross-sectional population-level comparison study of asthmatics from 1997-1998 and 2004-2005, researchers evaluated controller-to-total asthma medication ratio (greater than 0.5) with asthma exacerbation rates (dispensing of systemic corticosteroid or emergency department visit/hospitalization for asthma). They were able to demonstrate an increased use of asthma controllers based on a 16% increase in controller-to-total asthma medication ratio. However, there was no change in annual asthma exacerbation rates (0.27/year to 0.23/year) despite this improvement in controller use. [116]

Two systematic reviews indicate that the regular use of ICSs for the treatment of pediatric asthma may suppress linear growth in the first year of treatment, but lower ICS doses may minimize such effects. [1, 2, 117] The investigators of both reviews also noted that head-to-head comparison trials are needed to assess the effects of different ICSs, ICS doses, inhalation devices, and patient ages on growth suppression over time.

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