Part A | Â | Â | Â | Â | Â |
---|---|---|---|---|---|
Study | Population | Inhaled drug treatment | Treatment duration (months) | Definition of exacerbation | Severity of exacerbation |
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 |
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 | Â | Â | Â | Â | Â |
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 | Â | Â | Â | Â | Â |
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 | Â | Â | Â | Â | Â |
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 | Â | Â | Â | Â | Â |
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 |