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. Author manuscript; available in PMC: 2014 Jul 7.
Published in final edited form as: Curr Opin Pulm Med. 2012 Jan;18(1):70–75. doi: 10.1097/MCP.0b013e32834db017

Table 1.

Step-down from fixed dose combination ICS/LABA

Study/Reference Design N Duration Population Intervention Primary outcome Results Comment
Koenig 2008 (36) RDBPG 647 16 weeks Uncontrolled on low-moderate ICS but controlled on FSC 100/50 Step-down to FP100, SAL 50 or Montelukast PEF Control deteriorated in all step-down groups
Fowler 2002 (42) RDBPG 39 12 weeks Mod-severe asthma 1000 BDP BID X 4 weeks then BDP 200 2 x daily or FSC 100/50 2x daily PC20 Doubling dose improvement in MCT with FSC greater than either BDP dose Lung function and QOL better on FSC vs BDP step-down
Bateman 2006 (43) RDBPG 484 24 weeks Moderate asthma, well-controlled FSC 250/50 stepped down to FSC 100/50 vs FP 250 PEF PEF lower in FP vs FSC Symptoms, rescue albuterol and control better on FSC than FP
Godard 2008 (44) RDBPG 473 6 months Well controlled on FSC 250/50 Decrease to FSC 100/50 vs FP 250 PEF FSC 100/50 similar to 250/50 but better than FP 250
Reddel 2010 (45) RDBPG 82 13 months FSC 500/50 500/50 vs FP 500 and down titrated every 8 weeks Mean daily FP dose No difference in mean daily dose FP but final dose lower in FSC Question if patients were over treated

RDBPG=randomized, double blinded, parallel group; BDP=beclomethasone dipropionate; ICS=inhaled corticosteroid; BHR=bronchial hyperreactivity; CS=corticosteroids