Table 3.
Study Data for Trials Reporting Mean change in SGRQ Total Score and Patients Experiencing Any COPD Exacerbation
| Author, year | Treatment | Time point (weeks) | N Randomized | Definition of exacerbation | Annual exacerbation rate (any) | N with any exacerbation | Comparison data for Time to first exacerbation (Hazard ratio) | Mean change in SGRQ Total Score | Comparison data for SGRQ (treatment difference) |
|---|---|---|---|---|---|---|---|---|---|
| Bateman, 2010 [10] | Tiotropium 5 μg | 48 | 1989 | B+ | 0.69 | 685 | Tio vs. placebo: 0.93 | -4.7 | Tio5 vs. placebo: -2.9 |
| Placebo | 48 | 2002 | 0.87 | 842 | -1.8 | -- | |||
| Calverley, 2003 [30] | Budesonide/formoterol 320/9 mg (bid) | 52 | 254 | A | 1.38 | -- | B + F vs. B: 0.77 | -- | B + F vs. B: -4.5 |
| Budesonide 400 mg (bid) | 52 | 257 | 1.6 | -- | B + F vs. F: 0.71 | -- | B + F vs. F: -3.4 | ||
| Formoterol 9 mg (bid) | 52 | 255 | 1.85 | -- | B + F vs. Placebo: 0.72 | -- | B + F vs. Placebo: -7.5 | ||
| Placebo | 52 | 256 | 1.8 | -- | -- | -- | -- | ||
| Calverley, 2010 [12] | Beclomethasone/formoterol pMDI 400/24 μg | 48 | 237 | NR | 0.414 | 64 | -- | -3.75 | -- |
| Budesonide/formoterol DPI 800/24 μg | 48 | 242 | 0.423 | 64 | -- | -4.28 | -- | ||
| Formoterol DPI 12 μg | 48 | 239 | 0.431 | 66 | -- | -2.9 | -- | ||
| Casaburi, 2002 [31] | Tiotropium 18 μg | 52 | 550 | B | 0.76 | 198 | -- | -3.2 | -- |
| Placebo | 52 | 371 | 0.95 | 156 | -- | 0.5 | -- | ||
| Chapman, 2011 [13] | Indacaterol, 150 μg | 52 | 420 | A | -- | -- | Ind150 vs. Placebo: 0.82 | -7.5 | -- |
| Indacaterol, 300 μg | 52 | 418 | -- | -- | Ind300 vs. Placebo: 0.86 | -5.5 | -- | ||
| Placebo | 52 | 425 | -- | -- | -- | -5.5 | -- | ||
| Dahl, 2010 [14] | Indacaterol 300 μg | 52 | 437 | A | -- | -- | Inda300 vs. Placebo: 0.77 | -6.5 | Inda300 vs. Placebo: -4.7 |
| Indacaterol 600 μg | 52 | 428 | -- | -- | Inda600 vs. Placebo: 0.69 | -7.2 | Inda600 vs. Placebo: -4.6 | ||
| Formoterol | 52 | 435 | -- | -- | F vs. Placebo: 0.77 | -7 | F vs. Placebo: -4 | ||
| Placebo | 52 | 432 | -- | -- | -- | -1.7 | -- | ||
| Decramer, 2013 [15] | Tiotropium bromide 18 μg | 26 | 1721 | C | -- | -- | -- | -5.2 | -- |
| Indacaterol maleate 150 μg once-daily | 26 | 1723 | -- | -- | -- | -4.5 | -- | ||
| Tiotropium bromide 18 μg | 52 | 1721 | 0.61 | 547 | -- | -4.9 | -- | ||
| Indacaterol maleate 150 μg once-daily | 52 | 1723 | 0.79 | 619 | -- | -4.5 | -- | ||
| Ferguson, 2008 [17] | Fluticasone propionate/salmeterol (FSC) 250/50 | 52 | 394 | C | 4.82 | 343 | -- | -3.49 | FP/S vs. S: -1.86 |
| Salmeterol 50 μg | 52 | 388 | 5.78 | 335 | -- | -1.86 | -- | ||
| Vincken, 2002 [19] | Tiotropium 18 μg qd in the morning | 52 | 356 | B | 0.73 | 125 | -- | -3.74 | Tio18 vs. Ipra40: -3.3 |
| Ipratropium 40 μg qid | 52 | 179 | 0.96 | 82 | -- | -0.44 | -- | ||
| Wedzicha, 2014 [32] | beclomethasone dipropionate/formoterol fumarate (BDP/FOR) 100/6 μg, 2 inhalations BID | 48 | 602 | F | 0.8 | 264 | BDP + F vs. F: 0.8 | -3.55 | BDP/F vs. F: -2.78 |
| Formoterol fumarate (FOR) 12 μg, 1 inhalation BID | 48 | 597 | 1.12 | 294 | -- | -0.77 | -- | ||
| Wouters, 2005 [20] | Salmeterol/fluticasone (3 month run in period of salmeterol 50 μg and fluticasone 500 μg bid) | 52 | 189 | E | -- | 115 | -- | 2.4 | S/F vs. S: -0.89 |
| Salmeterol (3 month run in period of salmeterol 50 μg and fluticasone 500 μg bid) | 52 | 184 | -- | 109 | -- | 3.2 | -- |
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
E:If a patient has in ≥2 consecutive days used ≥3 extra inhalations of salbutamol per 24 hours above their reference rescue value
F:An acute event characterized by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication
-- = Not reported