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. 2016 Aug 1;29(4):346–361. doi: 10.1089/jamp.2015.1255

Table 1.

Summary of the Studies Included in the Pooled Analysis

Study Randomized patients (N) Blinding Treatment duration (weeks) Treatment Countries in which study performed Visit frequency during treatment period
FP/FORM studies
1a 280 Open-label 60 FP/FORM 250/10 μg MDI b.i.d. Argentina, Mexico, Peru, Romania, Ukraine, USA Every 12 weeks
2b 472 Open-label 26 or 52c FP/FORM 100/10 μg MDI b.i.d. or 250/10 μg MDI b.i.d. Germany, Hungary, Poland, Romania, United Kingdom Every 4 weeks
Lasserson et al. (32) Cochrane review of single inhaler FP/SAL versus single inhaler BUD/FORM
Aalbers, 2004 (35) 215
219
Open-label 28 BUD/FORM 400/12 μg TBH b.i.d.
FP/SAL 250/50 μg DSK b.i.d.
Denmark, Finland, Germany, Norway, Sweden, Netherlands NR
Busse, 2008 (36) 422
404
Open-label 28 BUD/FORM 400/12 μg MDI b.i.d.
FP/SAL 250/50 μg DSK b.i.d.
USA Months 1, 4 and 7
COMPASS (37) (Kuna 2007) 1099
1199
Double-blind 24 BUD/FORM 400/12 μg TBH b.i.d.
FP/SAL 250/50 μg MDI b.i.d.
16 countries (countries not specified) Every 8 weeks
EXCEL (38)
(Dahl, 2006)
697
694
Double-blind 24 BUD/FORM 400/12 μg TBH b.i.d.
FP/SAL 250/50 μg DSK b.i.d.
18 countries (countries not specified) Weeks 4, 8, 16 and 24
Ducharme et al (22) Cochrane review of addition of LABA to ICS versus same dose of ICS
Aubier, 1999 (39) Single inhaler 167 Double-blind 28 FP/SAL 500/50 μg DSK b.i.d. Germany, Netherlands & France Weeks 2, 4, 12, 20 and 28
Two inhalers 171 Double-blind 28 FP 500 DSK + SAL 50 μg DSK b.i.d.    
Fitzgerald, 1999 (40) 89 Double-blind 24 BUD, BDP or FLN 400–1200 μg DPI or MDI + FORM 12 μg Aeroliser b.i.d. Canada Months 1, 3, 5 and 6
OPTIMA (18) Low dose ICS 323 Double-blind 52 BUD 100 μg TBH + FORM 4.5 μg TBH b.i.d. 17 countries (countries not specified) 9 visits over 1 year
(O'Byrne, 2001) High dose ICS 315 Double-blind 52 BUD 200 μg TBH + FORM 4.5 μg TBH b.i.d.    
FACET (16) Low dose ICS 210 Double-blind 52 BUD 100 μg TBH + FORM 12 μg TBH b.i.d. Belgium, Canada, the Netherlands, Israel, Italy, Luxembourg, Norway, Spain, United Kingdom Week 2 and Months 1, 2, 3, 6, 9, and 12
(Pauwels, 1997) High dose ICS 215 Double-blind 52 BUD 400 μg TBH + FORM 12 μg TBH b.i.d.    
van der Molen, 1997 (41) 125 Double-blind 24 ICS (usual dose) DPI or MDI + FORM 24 μg TBH b.i.d. The Netherlands, Canada Weeks 4, 12 and 24
Chauhan and Ducharme (33) Cochrane review of addition to ICS of LABAs versus anti-leukotrienes
Bjermer, 2003 (42) 743 Double-blind 48 FP 100 μg DPI + SAL 50 μg MDI b.i.d. 37 countries (countries not specified) NR
Ilowite, 2004 (43) 730 Double-blind 48 FP 125 μg MDI + SAL 50 μg MDI b.i.d. USA NR
Price, 2011 (44) 182 Open-label 104 BDP, BUD or FP (DPI or MDI) + SAL (Diskhaler or DSK or MDI) or FORM (TBH or Aeroliser) United Kingdom Months 2, 6, 12, 18 and 24

BDP, beclometasone; b.i.d., twice daily; BUD, budesonide; DSK, Diskus; DPI, dry powder inhaler where various devices could be used;

FEV1, forced expiratory volume in 1 second; FLN, flunisolide; FORM, formoterol; FP, fluticasone propionate; ICS, inhaled corticosteroid; LABA, long-acting β2 agonist; NR, not reported; SAL, salmeterol; TBH, Turbuhaler.

Under treatment, a ‘/’ between the ICS and LABA denotes a fixed dose single-inhaler combination, while a ‘+’ denotes separate inhalers.

a

ClinicalTrials.gov identifier: NCT00747318 / EudraCT number: 2008-002460-34.

b

ClinicalTrials.gov identifier: NCT00394121 / EudraCT number: 2005-003518-14.

c

The first 80 patients in each dose group received treatment for 52 weeks; subsequent patients were treated for 26 weeks.