Table 1.
Table of Included Studies
| Study Year | Design Duration (mo) | Number (n) in AC BA Placebo | Mean Age in AC BA Placebo | FEV1 (L) in AC BA Placebo | Dropout (%) in AC BA Placebo | Treatment Groups | Concomitant Steroid Use (%) in AC BA Placebo | Comments |
|---|---|---|---|---|---|---|---|---|
| Aalbers 2002 | Parallel | 0 | NA | NA | NA | Formoterol 4.5 mcg, 9 mcg, 18 mcg BID Placebo | NA | Rescue BA |
| 3 | 514 | 62.6 | 1.44 | 16.3 | 100 | |||
| 173 | 61.8 | 1.47 | 15.6 | 100 | ||||
| Anthonisen 2002 Lung Health Study | Parallel | 1,961 | 48.4 | 2.62 | 26 | Ipratropium | Not stated | Unpublished information. Smoking intervention and usual care also studied |
| 60 | 0 | NA | 2.64 | NA | 36 mcg TID | |||
| 1,962 | 48.6 | NA | 24 | Placebo | ||||
| Boyd 1997 | Parallel | 0 | NA | NA | NA | Salmeterol 50 mcg, 100 mcg BID Placebo | NA | Rescue BA |
| 4 | 447 | 62.5 | 1.27 | 11.2 | 62 | |||
| 227 | 61 | 1.31 | 9.3 | 69 | ||||
| Brusasco 2003 | Parallel | 402 | 63.8 | 1.12 | 15.4 | Tiotropium 18 mcg QD Salmeterol 50 mcg BID Placebo | Not stated | Rescue BA |
| 6 | 405 | 64.1 | 1.07 | 18.8 | ||||
| 400 | 64.6 | 1.09 | 25.8 | |||||
| Calverley 2003 | Parallel | 0 | NA | NA | NA | Formoterol 9 mcg BID Placebo | NA | Unpublished information and erratum. Budesonide/Formoterol and Budesonide also studied |
| 12 | 255 | 63 | 1.00 | 43.5 | 0 | |||
| 256 | 65 | 0.98 | 41.4 | 0 | ||||
| Casaburi 2000 | Parallel | 279 | 65 | 1.04 | 6.1 | Tiotropium 18 mcg QD Placebo | Not stated | Rescue BA |
| 3 | 0 | NA | NA | NA | ||||
| 191 | 65.5 | 1.00 | 10.9 | |||||
| Casaburi 2002 | Parallel | 550 | 65 | 1.04 | 18.7 | Tiotropium 18 mcg QD Placebo | 50 | Rescue BA. Two phase 3 trials. Information from FDA website |
| 12 | 0 | NA | NA | NA | NA | |||
| 371 | 65 | 1.00 | 27.8 | 49 | ||||
| Chapman 2002 | Parallel | 0 | NA | NA | NA | Salmeterol 50 mcg BID | NA | Rescue BA |
| 6 | 201 | >40 | 1.19 | 9.9 | 68 | |||
| 207 | >40 | 1.28 | 13.5 | 55 | ||||
| Colice 1996 | Parallel | 113 | 63.7 | 1.02 | 13.3 | Ipratropium 500 mcg TID Albuterol 2,500 mcg TID | 49 | Treatments nebulized. Rescue BA |
| 3 | 110 | 64.7 | 0.99 | 19 | 46 | |||
| 0 | NA | NA | NA | NA | ||||
| Combivent 1997 | Parallel | 214 | 64.8 | 0.91 | 10.7 | Ipratropium 500 mcg TID Albuterol 3,000 mcg TID | Not stated | Treatments nebulized. No rescue BA allowed |
| 3 | 216 | 64.6 | 0.91 | 11.6 | ||||
| 0 | NA | NA | NA | |||||
| Cook 2001 | Cross-over | 0 | NA | NA | NA | Albuterol 200 mcg BID Placebo | NA | Rescue BA. |
| 3 each | 62 | 69.9 | 0.98 | 0 | 100 | |||
| 62 | 69.9 | 0.98 | 5 | 100 | ||||
| Donohue 2002 | Parallel | 209 | 64.5 | 1.11 | 12 | Tiotropium 18 mcg QD Salmeterol 50 mcg BID Placebo | 66 | Rescue BA |
| 6 | 213 | 64.6 | 1.07 | 16.9 | 72 | |||
| 201 | 65.6 | 1.06 | 27.8 | 73 | ||||
| Friedman 1999 | Parallel | 362 | 64 | 0.93 | 18.2 | Ipratropium 42 mcg QID Albuterol 240 mcg QID | 48 | No rescue BA allowed. Ipratropium + Albuterol studied |
| 3 | 347 | 64.6 | 0.95 | 14.1 | 41 | |||
| 0 | NA | NA | NA | NA | ||||
| Mahler 2002 | Parallel | 0 | NA | NA | NA | Salmeterol 50 mcg BID with and without fluticasone Placebo | NA | Rescue BA |
| 6 | 160 | 63.5 | 1.24 | 28.1 | 49 | |||
| 181 | 64 | 1.32 | 38.1 | 48 | ||||
| Niewoehner 2005 | Parallel | 914 | 67.6 | 1.04 | 163 | Tiotropium 18 mcg QD Placebo | 71 | Rescue BA |
| 6 | 0 | NA | NA | NA | NA | |||
| 915 | 68.1 | 1.04 | 26.7 | 69 | ||||
| Rossi 2002 | Parallel | 0 | NA | NA | NA | Formoterol 12 mcg, 24 mcg BID Placebo | NA | Rescue BA. Theophylline studied |
| 12 | 425 | Not | 1.38 | 21.6 | 47 | |||
| 220 | stated | 1.40 | 26.8 | 49 | ||||
| Rutten-van Molken 1999 | Parallel | 0 | NA | NA | NA | Salmeterol 50 mcg BID Placebo | NA | Rescue BA. Salmeterol+Ipratropium studied |
| 3 | 47 | 65.4 | 1.3 | 6.3 | 81 | |||
| 50 | 63.2 | 1.3 | 8 | 76 | ||||
| Szafranski 2003 | Parallel | 0 | NA | NA | NA | Formoterol 4.5 mcg BID with and without budesonide Placebo | NA | Rescue BA |
| 12 | 201 | 63 | 1.00 | 31.8 | 28 | |||
| 205 | 65 | 0.98 | 43.9 | 26 | ||||
| Tashkin 1986 | Parallel | 132 | 61.9 | 1.09 | 10.6 | Ipratropium 20 mcg QID Metaproterenol 750 mcg QID | 31 | No rescue BA allowed |
| 3 | 129 | 60.9 | 1.09 | 21.7 | 26 | |||
| 0 | NA | NA | NA | NA | ||||
| Taylor 2001 | Parallel | 379 | 65.8 | 1.06 | 11.1 | Ipratropium 42 mcg, 84 mcg QID Placebo | Not stated | Rescue BA |
| 3 | 0 | NA | NA | NA | ||||
| 128 | 64.8 | 1.06 | 17.1 | |||||
| Van Noord 2000 | Parallel | 0 | NA | NA | NA | Salmeterol 50 mcg BID Placebo | NA | Rescue BA. Salmeterol+Ipratropium studied |
| 3 | 47 | 65 | 1.3 | 14.9 | 91 | |||
| 50 | 63 | 1.3 | 16 | 78 | ||||
| Wadbo 2002 | Parallel | 62 | 64.8 | Not | 9.7 | Ipratropium 80 mcg BID Formoterol 18 mcg BID Placebo | Not stated | Rescue BA |
| 3 | 61 | 63.6 | listed | 26.2 | ||||
| 60 | 63.6 | 28.3 |
AC, anticholinergic; BA, β2-agonist, NA, not applicable; mcg, micrograms; QD, daily; BID, twice a day; TID, 3 times a day; QID, 4 times a day; FEV1, forced expiratory volume at 1 second.