. 2008 Dec;4(6):1201–1208. doi: 10.2147/tcrm.s3261

Table 1.

Clinical studies

Investigators	Design	Study doses	Results
qd, SABA only
Bensch et al 2006	N = 196, 12 week, PC Primary outcome: change in FEV₁	200 μg q AM	Improvement with 200 μg (16.8%) vs placebo (6%)
Nayak et al 2000	N = 236, 12 week, PC Primary outcome: change in FEV₁	200 μg q AM 400 μg q AM	Both doses better than placebo but 400 μg provided additional improvement
qd vs bid, SABA only
Kemp et al 2000	N = 306, 12 week, PC, Primary outcome: change in FEV₁	200 μg q AM, 400 μg q AM 200 μg bid	Total of 400 μg/day effective, either in qd or bid regimen Change in FEV₁ for 200 μg bid (16.1%), 400 μg qd (16.0%) significant over placebo (5.5%)
qd vs bid, previous ICS
Noonan et al 2001	N = 286, 12 week, PC, Primary outcome: change in FEV₁	200 μg bid, 200 μg q AM, 200 μg q PM, 400 μg q AM	400 μg q am maintained FEV₁, lung function, symptom scores 200 μg q PM improved FEV₁, not other measures 200 μg q AM not as effective
D’Urzo et al 2005	N = 400, 12 week, PC, Primary outcome: change in FEV₁	200 μg QD, 400 μg 1 inhal qd PM 400 μg (2 inhal of 200 μg) qd PM 200 μg bid	All doses better than placebo, including lowest dose. Similar improvement for all doses
Karpel et al 2005	N = 268, 12 week, PC, Primary outcome: change in FEV₁	400 μg q PM, 200 μg bid	Both doses better than placebo. Similar improvement for all doses
Pediatric
Berger et al 2006	N = 296, 12 week, 4–11 y.o.	100 μg q AM, 100 μg bid	Both doses better than placebo. Similar improvement for all doses
Reduced oral steroids in severe asthma
Fish et al 2000	N = 262, 12 week PC then 9 month open-label	400 μg bid 800 μg bid	OCS reduced by 46% (400 μg), 23.9% (800 μg), increased by 164.4% (placebo) OCS eliminated in 40% (400 μg), 37% (800 μg), 0% (placebo) Lung function and QofL improved
Karpel et al 2007	N = 123, 12-week, PC then 9-month open label	HFA-227 MDI 400 μg bid 800 μg bid	OCS reduced by 39.4% (400 μg), 31.1% (800 μg), increased by 107.2% (placebo) OCS reduced by ≥50% in 63% (400), 60% (800), 14% (P) Overall results: (with open label extension) 67% OCS reduction, 51% OCS elimination
Schmier et al 2003	Open label extension of Fish et al (2000)	400 μg bid 800 μg bid	SF-36 HRQL (QofL) maintained or improved for 3 months of open label extension
Comparative
Bousquet et al 2000	N = 12 week, AC Primary outcome: change in FEV₁	MF 100, 200, 400 μg bid, BUD 400 μg bid	MF 200, 400 bid superior to BUD 400 bid; MF 200 = 400 bid Conclusion: total 400 μg MF/day better than 800 μg BUD/day
Chervinsky et al 2002	N = 395, 4 week, PC Dose ranging, Primary outcome: change in FEV₁	MF-MDI 56, 200, 500 pg bid, BDP 168 μg bid	MF 200 pg bid better than MF 56 pg bid and BDP 168 μg bid All doses improved lung function, symptom scores, QOL No additional benefit from MF 500 pg bid
Corren et al 2003	N = 262, 8 week, PC Primary outcome: change in FEV₁	MF 440 μg q AM BUD DPI q AM	MF-DPI (8.9%) superior to BUD DPI (2.1%) or placebo (−3.9%)
Nathan et al 2001	N = 227, 12 week, PC Primary outcome: change in FEV₁	MF 100 μg or 200 μg bid BDP 168 μg bid	All doses better than placebo MF 200 μg bid most effective
O’Connor et al 2001	N = 733, 12 week, AC Dose-ranging Primary outcome: change in FEV₁	MF 100,200, or 400 μg bid FP diskhaler 250 μg bid	All doses improved outcome MF 400 μg /day comparable to FP 500 μg per day MF 800 μg /day no additional benefit. MF 200 μg /day least effective
Wardlaw et al 2004	N = 167, 8-week, open label, on previous FP Primary outcome: change in FEV₁	MF 400 μg q PM FP MDI 250 μg bid	“Comparable efficacy” between MF (4.58%) and FP (6.98%)

Abbreviations: AC, active controlled; BUD, budesonide; FEV₁, forced expiratory volume in 1 second; PC, placebo controlled; FP, fluticasone proprionate; MDI, metered dose inhaler; MF, mometasone furoate; OCS; chronic oral corticosteroids.