Table 4.
Exacerbation definition group (study typeb) |
Country (sample size) | Classification (stage of COPD) |
Mean number of exacerbations per patient and per yearc |
Treatment |
---|---|---|---|---|
Treatment | ||||
Burge et al., 2003 [58]d (CT) | United Kingdom (524) | GOLD (2 or 3) | 1.6-1.7 | Placebo |
1.1-1.4 | Fluticasone propionate | |||
Calverley et al., 2003 [59] (CT) | 25 countries (1,974) | GOLD (2 or 3) | 1.3 | Placebo |
1.0 | Salmeterol | |||
1.0 | Fluticasone | |||
1.0 | Salmeterol and fluticasone | |||
Jones et al., 2003 [60]d (CT) | United Kingdom (751) | GOLD (1 or 2) | 1.0 | Placebo |
0.7 | Fluticasone | |||
GOLD (3 or 4) | 1.7 | Placebo | ||
1.5 | Fluticasone | |||
Andersson et al., 2002 [61] (CT) | Sweden (191) | GOLD/BTS | 1.2 | |
Burge et al., 2000 [62]d (CT) | United Kingdom (751) | GOLD (2 or 3) | 1.9 (2.6) | Placebo |
1.4 (1.9) | Fluticasone | |||
Symptoms | ||||
Effing et al., 2009 [63] (CT) | Netherlands (142) | GOLD (2 or 3) | 3.5 (2.7) | |
Worth et al., 2009 [64]e (CT) | Germany (220) | GOLD (3 or 4) | 0.9 | Placebo |
0.4 | Cineole | |||
Schermer et al., 2009 [65] (CT) | Netherlands (286) | GOLD (1-3) | 0.7 | Placebo |
0.9 | Fluticasone | |||
1.0 | N-acetylcysteine | |||
O'Reilly et al., 2006 [66] (OS) | United Kingdom (309) | GOLD (1 or 2) | 2.2 [1.9-2.7] | Symptom-defined |
2.3 [2.0-2.8] | Healthcare-defined | |||
GOLD (3 or 4) | 2.5 [2.1-2.9] | Symptom-defined | ||
3.2 [2.8-3.7] | Healthcare-defined | |||
Wilkinson et al., 2006 [67] (OS) | United Kingdom (74) | GOLD (2 or 3) | 2.5 {1.3-3.8} | |
Donaldson et al., 2003 [68] (OS) | United Kingdom (132) | GOLD (2 or 4) | 2.5 {1.3-3.9} | |
Seemungal et al., 2000 [69] (OS) | United Kingdom (101) | GOLD (2 or 4) | 2.4 {1.3-3.8} | |
Treatment and symptoms | ||||
Seemungal et al., 2008 [70] (CT) | United Kingdom (109) | GOLD (2 or 3) | 2.0 | Placebo |
1.0 | Erythromycin | |||
Tashkin et al., 2008 [71] (CT) | 37 countries (5,993) | GOLD (2-4) | 0.8 | Placebo |
0.7 | Tiotropium | |||
Calverley et al., 2008 [72] (CT) | 11 countries (911) | GOLD (2 or 3) | 1.0 | Placebo |
0.6 | Mometasone furoate | |||
Wedzicha et al., 2008 [73] (CT) | 20 countries (1,323) | GOLD (3 or 4) | 1.3 | SFC |
1.3 | Tiotropium | |||
Dusser et al., 2006 [74] (CT) | France (1,010) | GOLD (1 or 2) | 2.0 | Placebo |
1.2 | Tiotropium | |||
GOLD (3 or 4) | 1.8 | Placebo | ||
2.7 | Tiotropium | |||
Soler-Cataluña et al., 2005 [55] (OS) | Spain (304) | GOLD (1) | (75, 25, 00)f | |
GOLD (2) | (60, 35, 05)f | |||
GOLD (3) | (56, 32, 12)f | |||
GOLD (4) | (34, 40, 26)f | |||
Oostenbrink et al., 2004 [75] (CT) | Netherlands and Belgium (519) | GOLD (1-4) | 1.0 (0.1) | Placebo |
0.7 (0.1) | Fluticasone | |||
Brusasco et al., 2003 [76] (CT) | 18 countries (1,207) | GOLD (2 or 3) | 1.5 | Placebo |
1.2 | Salmeterol | |||
1.1 | Tiotropium | |||
Model | ||||
Borg et al., 2004 [77] (M) | Netherlands | GOLD (1) | (0.05, 0.07, 0.01)g | |
GOLD (2) | (1.01, 1.31, 0.14)g | |||
GOLD (3) | (1.06, 1.45, 0.17)g | |||
GOLD (4) | (1.47, 1.72, 0.33)g | |||
Not defined | ||||
Detournay et al., 2004 [53] (OS) | France (255) | Moderate | 1.7 | |
Moderate to | 1.5 | |||
severe | ||||
Severe | 2.0 |
aCriteria used to define exacerbations were symptoms, treatment, symptoms and treatment or model-based. COPD stages are defined according to GOLD [53,55,59-62,66-69,74-77,90], BTS [61] and SPLF [53] criteria. bStudy type reported as CT, clinical trial; OS, observational study; M, model. cMean numbers of exacerbations per person and per year were reported in various ways: mean exacerbation or mean exacerbation (±SD) or mean exacerbation {min-max} or [95% confidence interval]. dThese three articles concern the same patients (the Inhaled Steroids in Obstructive Lung Disease trial). eThese estimates are based on 6 months of follow-up. The mean exacerbation in both groups during the previous year was 3.2. fThis article does not give the mean number of exacerbations but the proportion of patients who had, respectively, no acute exacerbations, one, two or three or more. gMean number of exacerbations per person and per year reported separately for mild, moderate and severe exacerbations. Abbreviations used: COPD, chronic obstructive pulmonary disease; BTS, British Thoracic Society classification; GOLD, Global Obstructive Lung Disease classification; SPLF, Société de Pneumonologie de Langue Française classification; SFC, salmeterol and fluticasone propionate (anti-inflammatory drug combination); ISOLDE, the Inhaled Steroids in Obstructive Lung Disease trial.