Characteristics of the 16 patients (13 men and three women) and reversibility on the selection day are shown in Table 1. Mean age was 48.6 (±10.8) years (range 32 to 68 years), mean height 174.8 (±8.7) cm and mean weight 80.6 (±15.9) kg. Mean baseline FEV, on the selection day was 1.86 (±0.62) L, which was 52 (±14) percent of the predicted value. The mean reversibility was 36 (±24) percent. Mean sys­tolic blood pressure was 136.9 (±8.1) mm Hg and mean diastolic blood pressure 83.8 (±5.9) mm Hg. Mean pulse rate was 80.4 (±7.2) per minute. No premature discontinuations were reported and no patient needed any additional puffs during the obser­vation period on either study day.



FIGURE 2. FEV, after inhalation of formoterol, 12 iLg(squares)md salbutamol, 200 jtg(stars). FEVi is expressed as mean (SEM) percentage of baseline. Mean baseline FJSV, formoterol 1.74 L salbutamol 1.77 L solid bar is reversibility selection day/(paired Students f-test: *p<0.Q5,**p<0.01,***p<0.001).

FEV, Mean baseline FEV, on the formoterol day was 1.74 (± 0.70) L (48 percent of predicted), on the salbutamol day 1.77 (±0.62) L (49 percent of predicted), which was not statistically significantly different (the range of the individual variation in FEV, between the treatment days was 1 to 20 percent). Figure 2 shows the percentage of increase in FEV, vs baseline in time. Both drugs produced a rapid increase in FEV, within the first hour. The maximum effect with sal­butamol was reached after 1 hour, but after formoterol, the FEV, continued to rise reaching its peak effect after 2 hours. From 2 hours up to 12 hours after administration, the bronchospasmolytic effect of for­moterol in comparison with that of salbutamol (meas­ured as the increase in FEV,) was significantly to very significantly higher. With formoterol, the FEV, was still more than 20 percent above the baseline 12 hours after administration, still a clinically relevant increase of FEV,. With salbutamol, the decline below the 20 percent level was reached between 4 and 6 hours after drug intake; after 10 hours, FEV, had practically returned to the baseline level. The mean FEV, 12 hours after administration of formoterol was 2.06 (±0.81) L, whereas it was 1.79 (±0.70) L after salbutamol. This was a statistically significant differ­ence (p = 0.003). On the formoterol day, the mean difference between FEV, 12 hours after administra­tion vs baseline FEV, was +0.33 L, and on the salbutamol day, + 0.03 L. This difference between the two treatments was also statistically significant (p = 0.001).
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Table 2—Systolic Blood Pressure (mm Hg)

Formoterol, Hours After
Administration

Salbutamol, Hours After
Administration

Patient

No.

0*)

1

2

4

6

8

10

12

0*)

1

2

4

6

8

10

12

01

130

125

125

125

115

125

125

135

125

125

120

125

125

125

120

120

02

120

120

130

125

125

125

125

130

120

135

120

125

130

120

130

135

03

120

125

110

115

110

120

120

120

120

125

120

115

120

110

115

115

04

140

135

135

135

135

130

125

130

130

135

135

135

130

140

140

140

05

130

125

120

125

120

130

140

150

145

135

125

135

140

135

140

145

06

140

145

150

145

150

145

145

150

150

145

150

140

150

145

155

150

07

130

130

140

135

130

130

140

140

145

130

140

135

130

125

135

140

08

130

145

140

140

130

125

140

140

135

130

130

130

130

140

150

140

09

145

145

140

135

140

145

140

145

145

145

145

125

140

130

130

125

10

140

140

145

140

135

140

150

150

130

135

135

140

135

145

145

135

11

135

145

145

145

130

140

145

135

145

140

140

145

140

135

135

140

12

130

130

135

135

135

135

135

135

125

125

125

130

135

140

140

140

13

145

135

145

130

140

140

125

140

135

135

135

125

130

140

140

145

14

130

140

140

140

135

140

145

140

135

135

140

145

135

– 140

140

145

15

135

130

135

135

135

130

140

145

145

130

130

145

145

140

145

145

16

140

140

145

135

130

130

135

130

135

130

135

130

135

140

135

140

Mean

134

135

136

134

131

133

136

138

135

133

133

133

134

134

137

138

Std

8

8

11

8

10

8

9

9

10

6

9

9

8

10

10

10

The AUC over 12 hours was significantly greater for formoterol than for salbutamol (p = 0.003). At the end of the study day, reversibility with 200 |xg salbutamol resulted on both treatment days in FEV, values comparable with reversibility on the selection day.

Unwanted Effects

No adverse reactions were reported on either treat­ment day.

Table 3—Diastolic Blood Pressure (mm Hg)

Formoterol, Hours After
Administration

Salbutamol, Hours After
Administration

Patient

*

1

No.

o*)

1

2

4

6

8

10

12

0*)

1

2

4

6

8

10

12

01

90

90

85

85

80

90

90

95

90

90

90

90

90

85

80

85

02

80

85

90

80

80

80

80

85

85

90

85

85

80

75

80

80

03

80

80

80

80

75

80

80

80

80

80

80

75

75

70

75

70

04

80

80

85

80

80

85

75

80

80

80

85

85

85

85

85

80

05

90

80

80

80

90

85

80

90

90

85

80

85

90

90

90

95

06

100

100

100

90

95

95

100

100

100

95

95

90

100

100

100

100

07

85

85

80

80

80

85

90

90

80

85

85

80

85

90

85

95

08

80

90

90

90

80

85

90

90

75

85

85

80

80

90

90

90

09

80

85

85

80

85

85

85

90

95

75

80

80

80

80

90

80

10

80

80

80

80

75

80

80

90

70

75

75

70

70

80

85

80

11

80

80

80

75

80

85

90

85

75

75

80

80

90

85

75

75

12

85

90

90

85

80

85

90

85

85

85

85

85

90

90

90

90

13

85

75

70

75

75

75

75

80

80

70

75

75

75

70

80

80

14

80

80

70

75

75

80

75

80

85

75

75

75

75

75

75

70

15

85

90

90

85

90

85

90

95

100

90

90

90

90

90

90

90

16

80

75

80

80

75

75

80

80

80

75

75

70

70

75

75

80

Mean

84

84

83

81

81

83

84

87

84

82

83

81

83

83

84

84

Std

6

7

8

5

6

5

7

6

9

7

6

7

9

9

7

9

Blood Pressure

No clinically relevant changes in mean or individual systolic or diastolic blood pressure could be observed on either treatment day (Table 2 and 3).
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Pulse Rate

On the formoterol day, as well as on the salbutamol day, the mean pulse rate over the 12 hours decreased by 6 beats per minute. No clinically relevant changes in individual pulse rate was observed (Table 4).

Table 4—Pulse Rate (Beats per Minute)

Formoterol, Hours After
Administration

Salbutamol, Hours After
Administration

Patient

*

No.

0*)

1

2

4

6

8

10

12

o*)

1

2

4

6

8

10

12

01

88

88

88

88

88

92

92

88

88

84

88

88

84

84

88

88

02

80

80

80

76

72

72

72

68

88

84

80

84

80

76

80

84

03

68

68

72

72

80

76

80

80

68

68

68

68

68

68

68

72

04

68

68

64

64

64

64

64

68

68

64

64

60

64

64

64

60

05

88

88

88

88

88

92

100

92

92

92

100

104

96

92

96

96

06

84

84

84

84

84

84

84

84

92

96

92

84

84

80

80

80

07

80

80

76

76

76

80

76

76

84

84

84

80

84

80

80

76

08

80

76

72

80

76

76

76

76

88

92

92

88

92

92

80

80

09

88

88

88

88

84

84

84

84

68

84

80

84

88

84

80

76

10

96

92

88

92

92

84

84

88

96

92

88

92

92

88

92

96

11

88

88

88

84

80

76

76

80

96

88

92

84

80

80

88

80

12

96

92

88

88

84

84

80

76

96

92

92

88

92

92

80

80

13

88

88

80

80

84

76

76

80

92

84

80

84

80

80

76

76

14

76

64

64

68

68

64

68

64

76

72

68

68

64

64

64

64

15

88

80

76

76

76

84

80

80

88

80

76

84

80

80

80

76

16

80

76

76

76

76

76

72

68

76

72

68

76

72

72

76

72

Mean

84

81

80

80

80

79

79

68

85

83

82

82

81

80

80

79

Std

8

9

9

8

8

8

9

8

10

10

11

10

10

9

9

10