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CLINICAL TRIALS Asthma In placebo-and albuterol-controlled, single-dose clinical trials with SEREVENT Inhalation Aerosol, the time to onset of effective bronchodilatation (>15% improvement in forced expiratory volume in 1 second [FEV1]) was 10 to 20 minutes after a 42-mcg dose. Maximum improvement in FEV1 generally occurred within 180 minutes, and clinically significant improvement continued for 12 hours in most patients. In 2 large, randomized, double-blind studies, SEREVENT Inhalation Aerosol was compared with albuterol and placebo in patients with mild-to-moderate asthma, including both patients who did and who did not receive concomitant inhaled corticosteroids. Text Continues Below
The efficacy of SEREVENT Inhalation Aerosol was demonstrated over the 12-week period with no change in effectiveness over this period of time. There were no gender-related differences in safety or efficacy. No development of tachyphylaxis to the bronchodilator effect has been noted in these studies. FEV1 measurements (percent of predicted) from these two 12-week trials are shown in
Figure 1 for both the first and last treatment days. Figure 1. FEV1, as Percent of Predicted, From 2 Large
12-Week Clinical Trials First Treatment Day Last Treatment Day (Week 12)
Table 1 shows the treatment effects seen during daily treatment with SEREVENT Inhalation
Aerosol for 12 weeks in patients with asthma. Table 1. Daily Efficacy Measurements in 2 Large 12-Week Clinical Trials (Combined
Data) Parameter Time Placebo
SEREVENT
Inhalation
Aerosol Albuterol
Inhalation
Aerosol
No. of randomized subjects 187 184 185 Mean AM peak expiratory
flow (L/min)
baseline
12 weeks
412
414
409
438 *
398
390 Mean % days with no
asthma symptoms
baseline
12 weeks
11
17
11
35 *
14
24 Mean % nights with no
awakenings
baseline
12 weeks
67
74
67
87 *
65
74 Rescue medications (mean
no. of inhalations per day)
baseline
12 weeks
4.4
3.3
4.1
1.3 †‡
4.0
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