Background
Methods
Data sources and selection
Data extraction
Study reporting quality assessment
Data synthesis and analysis
Role of the funding source
Results
Study characteristics
Part A | |||||
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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
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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
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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
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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
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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 |