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.
ClinicalTrials.gov identifier: NCT00747318 / EudraCT number: 2008-002460-34.
ClinicalTrials.gov identifier: NCT00394121 / EudraCT number: 2005-003518-14.
The first 80 patients in each dose group received treatment for 52 weeks; subsequent patients were treated for 26 weeks.