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CLINICAL TRIALS Asthma: During the initial treatment day in several multiple-dose clinical trials with SEREVENT DISKUS in patients with asthma, the median time to onset of clinically significant bronchodilatation ( 15% improvement in FEV1) ranged from 30 to 48 minutes after a 50-mcg dose. One hour after a single dose of 50 mcg of SEREVENT DISKUS, the majority of patients had 15% improvement in FEV1. Maximum improvement in FEV1 generally occurred within 180 minutes, and clinically significant improvement continued for 12 hours in most patients. In 2 randomized, double-blind studies, SEREVENT DISKUS was compared with albuterol inhalation aerosol and placebo in adolescent and adult patients with mild-to-moderate asthma (protocol defined as 50% to 80% predicted FEV1, actual mean of 67.7% at baseline), including patients who did and who did not receive concurrent inhaled corticosteroids. The efficacy of SEREVENT DISKUS was demonstrated over the 12-week period with no change in effectiveness over this time period (see Figure 1). There were no gender-or age-related differences in safety or efficacy. No development of tachyphylaxis to the bronchodilator effect was noted in these studies. FEV1 measurements (mean change from baseline) from these two 12-week studies are shown in Figure 1 for both the first and last treatment days. Text Continues Below
Figure 1. Serial 12-Hour FEV1 From Two 12-Week Clinical Trials in Patients With Asthma First Treatment Day
Last Treatment Day (Week 12)
Table 1 shows the treatment effects seen during daily treatment with SEREVENT DISKUS for 12 weeks in adolescent and adult patients with mild-to-moderate asthma. Table 1. Daily Efficacy Measurements in Two 12-Week Clinical Trials (Combined Data) Parameter Time Placebo SEREVENT DISKUS
Albuterol Inhalation Aerosol No. of randomized subjects 152 149 148
Mean AM peak expiratory flow (L/min)
Mean % days with no asthma symptoms
Mean % nights with no awakenings
Rescue medications (mean no. of inhalations per day)
Asthma exacerbations
baseline 12 weeks
baseline 12 weeks
baseline 12 weeks
baseline 12 weeks
394 396
14 20
70 73
4.2 3.3
14%
395 427 *
13 33
63 85 *
4.3 1.6 †
15%
394 394
12 21
68 71
4.3 2.2
16% * Statistically superior to placebo and albuterol (p<0.001). † Statistically superior to placebo (p<0.001). Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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