In a double-blind, crossover, single dose study, we studied 16 patients in random-permuted blocks of four patients, ages 18 to 70 years, with stable bronchial asthma, who had previously shown an increase in FEVi of 20 percent or more 15 minutes after inhaling 200 |ig of salbutamol metered-dose aerosol. All patients gave their informed consent for this study, which had previously been approved by the Institutional Ethical Review Committee. On two study days, separated by one day of rest, patients received either two puff’s of 6 ug formoterol metered-dose aerosol or two puffs of 100 ug matching salbutamol metered-dose aerosol. Baseline FEV| values on these study days were at least 1.0 L and less than 80 percent of the predicted value (based on the guidelines for standardized lung (unction testing from the European Community for Coal and Steel) with an individual variation of less than 20 percent between the two values. (Table 1). Patients arrived at the outpatient clinic at 9.00 am. Inhaled beta,-agonist and anticholinergic agents were withheld for 8 hours, oral beta^agonists for 24 hours, and slow release theophylline for 36 hours. Patients taking inhaled/oral corticoste­roids or cromoglycates continued this treatment at a constant dose throughout the study. Smoking and use of caffeine-containing drinks was not allowed during the observation period. After 30 minutes of resting, the following baseline measurements were made using a pulmograph (Sensor Medics): FEy„ FVC, and FEF25-75% during the middle half of the FVC were recorded three times and the highest values (BTPS corrected) were used. Pulse rate was measured by counting during 30 seconds and blood pressure was determined by a mercury-sphygmomanometer using the mean of two recordings.

Table 1—Patient Characteristics

Patient No.

Sex

Age,

yr

Height, cm

Weight, kg

FEV,

Treatment

Baseline, L

(% pred)

Reversibility

Oral

Inhaled

01

M

48

187

33

2.55

61

20

be

sa,
becl

02

M

44

188

107

1.55

36

51

be

becl

03

M

42

172

86

1.92

52

22

th, tb

fe

04

M

34

182

114

3.49

80

21

fe, becl, ip

05

M

42

170

68

1.53

42

26

th, be

fe

06

M

53

171

90

1.36

41

21

fe

07

M

62

183

84

1.57

44

49

sa,
becl, cr

08

M

62

168

72

2.14

73

20

sa,
becl

09

M

45

168

86

1.24

36

81

th

fe, becl

10

F

60

169

62

1.50

57

21

sa,
becl

11

F

55

165

55

1.97

60

52

sa,
becl, cr, ke

12

F

68

160

68

1.42

61

27

sa, becl

13

M

50

171

76

1.64

48

23

be

fe

14

M

32

187

92

1.86

41

100

be

sa,
becl

15

M

45

174

64

1.22

33

22

sa,
becl

16

M

35

182

82

2.78

64

24

sa,
becl

After these baseline measurements, either 12 |ig formoterol or 200 \Lg salbutamol was administered and the above measurements were repeated 1, 2, 4, 6, 8, 10 and 12 hours hereafter. At the end of the day (ie, 12 hours after administration of the drug), reversibility was recorded by administration of two pufis of 100 |tg salbutamol followed by another registration of FEVt, FVC, and FEF25-75%. When the FE V, deteriorated during the day by more than 20 percnt compared to the baseline value, patients were given two puffs of 100 jig salbutamol and the length of time between start of the trial and this administration was recorded. Unwanted effects and details of their severity, time of onset, duration and relation to the trial treatment were recorded throughout the study days. A wash-out period of 36 hours was then scheduled before repeating the test with the other drug, ie, either 12 ug formoterol or 200 ug salbutamol. The Students f-test for paired measurements was used for statistical comparison. All statisical tests were carried out as a two-sided test at the 5 percent level (alpha = 0.025).
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