Table 1.
Study Data for Trials Reporting Mean Change in Trough FEV1 and Patients Experiencing Any Exacerbation
| Author, Year | Treatment | Time point (weeks) | N Randomized | Definition of exacerbation | Annual exacerbation rate | N with any exacerbation | Comparison data for Time to first exacerbation (Hazard ratio) | Mean change in Trough FEV1 (L) | Comparison data for Trough FEV1 (treatment difference) |
|---|---|---|---|---|---|---|---|---|---|
| Bateman, 2010 [10] | Tiotropium 5 ug | 48 | 1989 | B+ | 0.12 | 685 | Tio5 vs. Placebo: 0.69 | 0.119 | -- |
| Placebo | 48 | 2002 | 0.15 | 842 | 0.018 | -- | |||
| Calverley, 2010 [12] | Beclomethasone/formoterol pMDI 400/24 μg | 48 | 237 | NR | 0.074 | 64 | -- | 0.077 | B/F pMDI vs. F-DPI: 0.051 |
| Budesonide/formoterol DPI)800/24 μg | 48 | 242 | 0.033 | 64 | -- | 0.08 | B/F dry vs. F-DPI: 0.053 | ||
| Formoterol DPI 12 μg | 48 | 239 | 0.04 | 66 | -- | 0.026 | -- | ||
| Chapman, 2011 [13] | Indacaterol, 150 μg | 52 | 420 | A | -- | -- | Ind150 vs. Placebo: 0.82 | 0.12 | -- |
| Indacaterol, 300 μg | 52 | 418 | -- | -- | Ind300 vs. Placebo: 0.86 | 0.13 | -- | ||
| Placebo | 52 | 425 | -- | -- | -0.04 | -- | |||
| Dahl, 2010 [14] | Indacaterol 300 μg | 52 | 437 | A | -- | -- | Inda300 vs. Placebo: 0.77 | -- | Inda300 vs. Placebo: 0.16 |
| Indacaterol 600 μg | 52 | 428 | -- | -- | Inda600 vs. Placebo: 0.69 | -- | Inda600 vs. Placebo: 0.15 | ||
| Formoterol | 52 | 435 | -- | -- | F vs. Placebo: 0.77 | -- | F vs. Placebo: 0.05 | ||
| Placebo | 52 | 432 | -- | -- | -- | -- | |||
| Decramer, 2013 [15] | Tiotropium bromide 18 μg | 26 | 1721 | C | -- | -- | Tio18 vs. Inda150: 0.81 | -- | Tio18 vs. Inda150: 0.02 |
| Indacaterol maleate 150 μg once-daily | 26 | 1723 | -- | -- | -- | -- | |||
| Tiotropium bromide 18 μg | 52 | 1721 | 0.07 | 547 | -- | 0.092 | -- | ||
| Indacaterol maleate 150 μg once-daily | 52 | 1723 | 0.1 | 619 | -- | 0.073 | -- | ||
| Dusser, 2006 [16] | Tiotropium 18 μg once daily | 48 | 500 | C | -- | 248 | -- | -- | -- |
| Placebo | 48 | 510 | -- | 305 | -- | -- | Tio18 vs. Placebo: 0.12 | ||
| Ferguson, 2008 [17] | Fluticasone propionate/salmeterol (FSC) 250/50 | 52 | 394 | C | -- | 343 | -- | -0.012 | -- |
| Salmeterol 50 μg | 52 | 388 | -- | 335 | -- | -0.082 | -- | ||
| van Grunsven, 2003 [18] | Fluticasone propionate (Flixotides) 250 μg bid | 103 | 24 | D | -- | 5 | -- | -0.12 | F250 vs. Placebo: 0.06 |
| Placebo bid | 103 | 24 | -- | 3 | -- | -0.17 | -- | ||
| Vincken, 2002 [19] | Tiotropium 18 μg qd in the morning | 52 | 356 | B | -- | 125 | -- | 0.12 | -- |
| Ipratropium 40 μg qid | 52 | 179 | -- | 82 | -- | -0.03 | -- | ||
| Wouters, 2005 [20] | Salmeterol/fluticasone (3 month run in period of salmeterol 50 μg and fluticasone 500 μg bid) | 52 | 189 | E | -- | 115 | -- | -0.04 | S/F vs. S: 0.05 |
| Salmeterol (3 month run in period of salmeterol 50 μg and fluticasone 500 μg bid) | 52 | 184 | -- | 109 | -- | -0.1 | -- | ||
| Zhou, 2006 [21] | Theophylline | 52 | 57 | C | -- | 26 | -- | 0.0063 | -- |
| Placebo | 52 | 53 | -- | 30 | -- | -0.0533 | -- | ||
| Dransfield, 2013 [22] | Vilanterol 25 μg | 52 | 409 | A | -- | 203 | -- | -0.04 | -- |
| Fluticasone furoate 50 μg + Vilanterol 25 μg | 52 | 408 | -- | 190 | -- | 0 | -- | ||
| Fluticasone furoate 100 μg + Vilanterol 25 μg | 52 | 403 | -- | 161 | -- | 0.02 | -- | ||
| Fluticasone furoate 200 μg + Vilanterol 25 μg | 52 | 402 | -- | 178 | -- | 0.02 | -- | ||
| Vilanterol 25 μg | 52 | 409 | -- | 197 | -- | -0.02 | -- | ||
| Fluticasone furoate 50 μg + Vilanterol 25 μg | 52 | 412 | -- | 198 | -- | 0.02 | -- | ||
| Fluticasone furoate 100 μg + Vilanterol 25 μg | 52 | 403 | -- | 177 | -- | 0.01 | -- | ||
| Fluticasone furoate 200 μg + Vilanterol 25 μg | 52 | 409 | -- | 160 | -- | 0.01 | -- |
Exacerbation Definitions:
A:Symptom deterioration requiring antibiotics, systemic corticosteroids, and/or hospitalization
B:A complex of respiratory events lasting ≥3 days
B+:A complex of respiratory events lasting ≥3 days requiring treatment
C:Worsening of at least two symptoms for at least two days
D:Having two of the following three symptoms: increased cough, wheezing and/or dyspnea; change in sputum color; use of bronchodilator rescue medication
E:If a patient has in ≥2 consecutive days used ≥3 extra inhalations of salbutamol per 24 hours above their reference rescue value
-- = Not Reported