Table 1.
Study Characteristics of Randomized Controlled Trials Included in Meta-analysis
| Source/Intervention | Medication | No. | FEV1, % Predicted, Mean (SD) |
Current Smoker, No. (%) |
Trial Length, mo |
Definition of Pneumonia in Primary Manuscript |
Primary Outcome |
Outcome Results (Treatment vs Control) |
|---|---|---|---|---|---|---|---|---|
| Aaron et al,35 2007 | ||||||||
| Treatment | Fluticasone (500 µg)/salmeterol (50 µg) twice daily + tiotropium (18 µg) daily | 145 | 39 (11.9) | 46 (32) | 12 | Definition not provided | Proportion of participants experiencing ≥1 exacerbation | 60% vs 64.8% (absolute risk reduction, 4.8) |
| Control | Salmeterol (50 µg) twice daily/tiotropium (18 µg) daily | 148 | 38 (13.1) | 36 (24) | ||||
| Burge et al,10 2000 | ||||||||
| Treatment | Fluticasone (500 µg) twice daily | 372 | 50 (14.9) | 145 (36) | 36 | Lower respiratory tract event | Decline in FEV1 | −50 (SE, 4.1) mL/y vs −59 (SE, 4.4) mL/y (P = .16) |
| Control | Placebo twice daily | 370 | 50 (14.9) | 144 (39) | ||||
| Calverley et al,11 2003 | ||||||||
| Treatment | Budesonide (400 µg) twice daily | 257 | 36 (10) | 100 (39) | 12 | Definition not provided | Days to first exacerbation; percent change in FEV1 | 178 vs 96 (P = .51); 2% (P = .15) |
| Control | Placebo twice daily | 256 | 36 (10) | 77 (30) | ||||
| Treatment | Budesonide (320 µg)/formoterol (9 µg) twice daily | 254 | 36 (10) | 84 (33) | 12 | Definition not provided | Days to first exacerbation; percent change in FEV1 | 254 vs 154 (P < .01); 5% (P < .01) |
| Control | Formoterol (9 µg) twice daily | 255 | 36 (10) | 92 (36) | ||||
| Calverley et al,12 2007 | ||||||||
| Treatment | Fluticasone (500 µg) twice daily | 1534 | 44 (12.3) | 661 (43) | 36 | Definition not provided | All-cause mortality | 16.0% vs 15.2% (P = .53) |
| Control | Placebo twice daily | 1524 | 44 (12.3) | 658 (43) | ||||
| Treatment | Fluticasone (500 µg)/salmeterol (50 µg) twice daily | 1533 | 44 (12.3) | 660 (43) | 36 | Definition not provided | All-cause mortality | 12.6% vs 13.5% (P = .48) |
| Control | Salmeterol (50 µg) twice daily | 1521 | 44 (12.6) | 651 (43) | ||||
| Kardos et al,13 2007 | ||||||||
| Treatment | Fluticasone (500 µg)/salmeterol (50 µg) twice daily | 507 | 40 (8.9) | 208 (41) | 12 | Suspected pneumonia; confirmation by radiograph not required. | No. of moderate and severe exacerbations | 334 vs 464 exacerbations (P < .001) |
| Control | Salmeterol (50 µg) twice daily | 487 | 40 (8.5) | 214 (44) | ||||
| Lung Health Study Research Group,34 2000 | ||||||||
| Treatment | Triamcinolone (600 µg) twice daily | 559 | 65 (13.5) | 509 (91) | 40a | Pneumonia outcome not reported | Decline in FEV1 | 44.2 (SE, 2.9) mL/y vs 47.0 (SE, 3.0) mL/y (P = .50) |
| Control | Placebo twice daily | 557 | 63 (13.2) | 501 (90) | ||||
| Pauwels et al,36 1999 | ||||||||
| Treatment | Budesonide (400 µg) twice daily | 634 | 77 (12.4) | 634 (100) | 36 | Pneumonia outcome not reported | Change in FEV1 over 3 years | 140 mL vs 180 mL (P = .05) |
| Control | Placebo twice daily | 643 | 77 (13.2) | 643 (100) | ||||
| Szafranski et al,14 2003 | ||||||||
| Treatment | Budesonide (200 µg) twice daily | 198 | 37 | 71 (36) | 12 | Pneumonia outcome not reported | Percent reduction in severe exacerbation rate; percent change in FEV1 | 15% (95% CI, −10.3% to 34.1%; P = .22); 5% (95% CI, 1.5% to 9.1%; P = .005) |
| Control | Placebo twice daily | 205 | 36 | 70 (34) | ||||
| Treatment | Budesonide (160 µg)/formoterol (4.5 µg) twice daily | 208 | 36 | 62 (30) | 12 | Pneumonia outcome not reported | Percent reduction in severe exacerbation rate; percent change in FEV1 | 23% (95% CI, 0.8% to 40.1%; P = .043); 1% (95% CI, −2.2% to 4.9%; P = .49) |
| Control | Formoterol (4.5 µg) twice daily | 201 | 36 | 76 (38) | ||||
| Vestbo et al,37 1999 | ||||||||
| Treatment | Budesonide (800 µg every morning/400 µg every evening × 4 mo; then 400 µg twice daily) | 145 | 86 (20.8) | 110 (76) | 36 | Definition not provided | Decline in FEV1 | 45.1 mL/y vs 41.8 mL/y (P = .70) |
| Control | Placebo (2 puffs every morning/1 puff every evening × 4 mo; then 1 puff twice daily) | 145 | 87 (21.1) | 112 (77) | ||||
| Wedzicha et al,15 2008 | ||||||||
| Treatment | Fluticasone (500 µg)/salmeterol (50 µg) twice daily | 658 | 39 | 250 (38) | 24 | Clinical judgment; confirmation by radiograph not required | Exacerbation rate | 1.28 vs 1.32 exacerbations/y (P = .66) |
| Control | Tiotropium (18 µg) daily | 665 | 39 | 253 (38) | ||||
| Zheng et al,16 2007 | ||||||||
| Treatment | Fluticasone (500 µg)/salmeterol (50 µg) twice daily | 297 | 47 | 62 (21) | 6 | Pneumonia outcome not reported | 6-mo change in FEV1 | 180 mL (95% CI, 91 to 268; P < .001) higher comparing treatment vs control |
| Control | Placebo twice daily | 148 | 47 | 34 (23) | ||||
Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in first second of expiration.
a
Average length of follow-up.