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Table 3 Moderate and severe exacerbations of COPD by treatment groups

From: A double-blind, randomised, placebo-controlled study of roxithromycin and doxycycline combination, roxithromycin alone, or matching placebo for 12 weeks in adults with frequent exacerbations of chronic obstructive pulmonary disease

 

Roxithromycin + Doxycycline (n = 101)

Roxithromycin (n = 97)

Placebo (n = 94)

Through 48-week period post treatment

   Number of exacerbations

N

% of overall exacerbations

N

% of overall exacerbations

N

% of overall exacerbations

  Overall

263

 

302

 

261

 

  Moderate and severe

217

82.51 %

221

73.18 %

193

73.94 %

   Event rate/patient year

      

  Overall

3.43

 

3.67

 

3.38

 

  Moderate and severe

2.83

aP = 0.352

2.69

aP = 0.5832

2.50

 

During 12-week active treatment period

   Number of exacerbations

N

% of overall exacerbations

N

% of overall exacerbations

N

% of overall exacerbations

  Overall

52

 

51

 

67

 

  Moderate and severe

37

71.15 %

39

76.47 %

48

71.64 %

   Event rate/patient year

      

  Overall

2.31

 

2.27

 

3.14

 

  Moderate and severe

1.64

aP = 0.1709

1.74

aP = 0.2545

2.25

 

During the first 24-week period post treatment

   Number of exacerbations

N

% of overall exacerbations

N

% of overall exacerbations

N

% of overall exacerbations

  Overall

146

 

150

 

141

 

  Moderate and severe

117

80.13 %

108

72 %

103

73.05 %

   Event rate/patient year

      

  Overall

3.72

 

3.57

 

3.55

 

  Moderate and severe

2.98

aP = 0.3864

2.57

aP = 0.9577

2.59

 

During the last 24 week period post treatment

   Number of exacerbations

N

% of overall exacerbations

N

% of overall exacerbations

N

% of overall exacerbations

  Overall

117

 

152

 

120

 

  Moderate and severe

100

85.47 %

113

74.34 %

90

75 %

   Event rate/patient year

      

  Overall

3.12

 

3.78

 

3.20

 

  Moderate and severe

2.67

aP = 0.5426

2.81

aP = 0.3496

2.40

 
  1. Number and event rate (per patient year) of moderate and severe exacerbations in each treatment group. aP values shown are from comparison of event rate with the placebo group