Table 1 Study characteristics

Baumgartner et al 2007 [48]

n = 433 (58% males)

Mean age in years: 63

Mean FEV1: 41% predicted

Group 1: Salmeterol 42 μg bid

Group 2: Formoterol 25 μg bid

Group 3: Placebo

3

Event-based

Moderate and severe

Beeh et al 2006 [21]

n = 1639 (76% males)

Mean age in years: 62

Mean FEV1: 45% predicted

Group 1: Tiotropium 18 μg qd

Group 2: Placebo

3

Event-based

Moderate and severe

Bourbeau et al 1998 [22]

n = 79 (66% males)

Mean age in years: 66

Mean FEV1: 43% predicted

Group 1: Budesonide 800 μg bid

Group 2: Placebo

6

Event-based

Moderate and severe

Boyd et al 1997[23]

n = 445 (79% males)

Mean age in years: 62

Mean FEV1: ≈65% predicted (only FEV1 in liters reported)

Group 1: Salmeterol 50 μg bid

Group 2: Placebo

3.5

Event-based

Moderate and severe

Briggs et al 2005[49]

n = 653 (66% males)

Mean age in years: 64

Mean FEV1: 38% predicted

Group 1: Tiotropium 18 μg qd

Group 2: Salmeterol 50 μg bid

3

Symptom-based

Moderate and severe

Brusasco et al 2003 [24, 35]

n = 1207 (76% males)

Mean age in years: 64

Mean FEV1: 38% predicted

Group 1: Tiotropium 18 μg qd

Group 2: Salmeterol 50 μg bid

Group3: Placebo

6

Symptom-based

Moderate and severe

Burge et al 2000 [25]

n = 742 (75% males)

Mean age in years: 64

Mean FEV1: 50% predicted

Group 1: Fluticasone 500 μg bid

Group 2: Placebo

36

Event-based

Moderate and severe

Calverley et al 2003 [26]

n = 1465 (76% males)

Mean age in years: 63

Mean FEV1: 45% predicted

Group 1: Salmeterol 50 μg bid

Group 2: Fluticasone 500 μg bid

Group 3: Salmeterol 50 μg bid + Fluticasone 500 μg bid

Group 4: Placebo

12

Event-based

Moderate and severe

Part B

Calverley et al 2003 [27]

n = 1022 (73% males)

Mean age in years: 64

Mean FEV1: 36% predicted

Group 1: Formoterol 9 μg bid

Group 2: Budesonide 400 μg bid

Group 3: Formoterol 9 μg bid + Budesonide 320 μg bid

Group 4: Placebo

12

Event-based

Moderate and severe

Calverley et al 2003 [28]

n = 78 (60% males)

Mean age in years: 65

Mean FEV1: 40% predicted

Group 1: Tiotropium 18 μg qd

Group 2: Placebo

6

Event-based

Moderate and severe

Calverley et al 2007 [14]

n = 6112 (76% males)

Mean age in years: 65

Mean FEV1: 44% predicted

Group 1: Salmeterol 50 μg bid

Group 2: Fluticasone 500 μg bid

Group 3: Salmeterol 50 μg bid + Fluticasone 500 μg bid

Group 4: Placebo

36

Event-based

Severe

Campbell et al 2005 [29]

n = 432 (67% males)

Mean age in years: 60

Mean FEV1: 54% predicted

Group 1: Formoterol 9 μg bid

Group 2: Placebo

6

Event-based

Moderate and severe

Casaburi et al 2002 [50]

n = 921 (65% males)

Mean age in years: 65

Mean FEV1: 36% predicted

Group 1: Tiotropium 18 μg qd

Group 2: Placebo

12

Symptom-based

Moderate and severe

Celli et al 2003 [30]

n = 824 (70% males)

Mean age in years: 64

Mean FEV1: 42% predicted

Group 1: Salmeterol 50 μg bid

Group 2: Placebo

3

Event-based

Moderate and severe

Chapman et al 2002 [31]

n = 408 (64% males)

Mean age: not reported

Mean FEV1: 45% predicted

Group 1: Salmeterol 50 μg bid

Group 2: Placebo

5.5

Event-based

Moderate and severe

Covelli et al 2004 [32]

n = 196 (66% males)

Mean age in years: 65

Mean FEV1: 40% predicted

Group 1: Tiotropium 18 μg qd

Group 2: Placebo

3

Symptom-based

Moderate and severe

Part C

Dahl et al 2001 [33]

n = 392 (75% males)

Mean age in years: 64

Mean FEV1: 45% predicted

Group 1: Formoterol 24 μg bid

Group 2: Placebo

3

Event-based

Severe

Dusser et al 2006 [34]

n = 1010 (88% males)

Mean age in years: 65

Mean FEV1: 48% predicted

Group 1: Tiotropium 18 μg qd

Group 2: Placebo

12

Event-based

Moderate and severe

Hanania et al 2003 [51]

n = 540 (63% males)

Mean age in years: 64

Mean FEV1: 42% predicted

Group 1: Salmeterol 50 μg bid

Group 2: Fluticasone 250 μg bid

Group 3: Salmeterol 50 μg bid + Fluticasone 250 μg bid

Group 4: Placebo

5.5

Event-based

Moderate and severe

Kardos et al 2007 [52]

n = 994 (76% males)

Mean age in years: 64

Mean FEV1: 40% predicted

Group 1: Salmeterol 50 μg bid

Group 2: Salmeterol 50 μg bid + Fluticasone 500 μg bid

10

Event-based

Moderate and severe

Littner et al 2000 [36]

n = 68 (65% males)

Mean age in years: 66

Mean FEV1: 42% predicted

Group 1: Tiotropium 18 μg qd

Group 2: Placebo

1

Symptom-based

Moderate and severe

Mahler et al 1999 [37]

n = 278 (74% males)

Mean age in years: 63

Mean FEV1: 40% predicted

Group 1: Salmeterol 42 μg bid

Group 2: Placebo

3

Symptom-based

Moderate and severe

Mahler et al 2002 [38]

n = 671 (66% males)

Mean age in years: 64

Mean FEV1: 41% predicted

Group 1: Salmeterol 50 μg bid

Group 2: Fluticasone 500 μg bid

Group 3: Salmeterol 50 μg bid + Fluticasone 500 μg bid

Group 4: Placebo

5.5

Event-based

Moderate and severe

Part D

Niewoehner et al 2005 [39]

n = 1829 (99% males)

Mean age in years: 68

Mean FEV1: 36% predicted

Group 1: Tiotropium 18 μg qd

Group 2: Placebo

6

Event-based

Moderate and severe

Paggiaro et al 1998 [40]

n = 281 (74% males)

Mean age in years: 63

Mean FEV1: 57% predicted

Group 1: Fluticasone 500 μg bid

Group 2: Placebo

12

Event-based

Moderate and severe

Paggiaro et al 2006 [41]

n = 114 (73% males)

Mean age in years: 66

Mean FEV1: 53% predicted

Group 1: Flunisolide 1 mg bid

Group 2: Placebo

6

Event-based

Moderate and severe

Rossi 2002[42]

n = 434 (84% males)

Mean age in years: 63

Mean FEV1: 47% predicted

Group 1: Formoterol 25 μg bid

Group 2: Placebo

3

Event-based

Moderate and severe

Stockley et al 2006 [43]

n = 634 (76% males)

Mean age in years: 62

Mean FEV1: 46% predicted

Group 1: Salmeterol 50 μg bid

Group 2: Placebo

12

Event-based

Moderate and severe

Szafranski et al 2000 [44]

n = 812 (79% males)

Mean age in years: 64

Mean FEV1: 36% predicted

Group 1: Formoterol 4.5 μg bid

Group 2: Budesonide 200 μg bid

Group 3: Formoterol 4.5 μg bid + Budesonide 160 μg bid

Group 4: Placebo

12

Event-based

Moderate and severe

Van der Valk et al 2002 [45]

n = 244 (84% males)

Mean age in years: 64

Mean FEV1: 57% predicted

Group 1: Fluticasone 500 μg bid

Group 2: Placebo

5.5

Event-based

Moderate and severe

Part E

Van Noord et al 2000 [46]

n = 92 (88% males)

Mean age in years: 65

Mean FEV1: 41% predicted

Group 1: Salmeterol 50 μg bid

Group 2: Placebo

3

Event-based

Moderate and severe

Wadbo et al 2002 [47]

n = 121 (53% males)

Mean age in years: 64

Mean FEV1: 33% predicted

Group 1: Formoterol 18 μg bid

Group 2: Placebo

3

Symptom-based

Moderate and severe

Wedzicha et al 2008 [53]

n = 1323 (83% males)

Mean age in years: 64

Mean FEV1: 39% predicted

Group 1: Tiotropium 18 μg qd

Group 2: Salmeterol 50 μg bid + Fluticasone 500 μg bid

24

Event-based

Moderate and severe

Weir et al 1999 [54]

n = 98 (72% males)

Mean age in years: 66

Mean FEV1: not reported

Group 1: Beclomethasone 750–1000 μg bid

Group 2: Placebo

5.5

Symptom-based

Moderate and severe