In: COPD20 Mar 2014
For the first 4 h after drug administration, the FEVjl response AUC for the combination therapy was significantly greater than the response to each of its components on each of the 4 test days (Table 5). For the entire 8-h period, combination therapy means were greater than IB and albuterol means. The difference from IB was statistically different only on day 1 and from albuterol on all test days except day 29 in which the p value was 0.054. The differences between treatments were consistent across centers. canadian health&care mall
The median time to onset of a 15% increase in FEVX was 15 min (the first time point measured after drug administration) for each treatment group on each test day. The median duration of action for the combination therapy group ranged from 3 to 5 h (Table 6). The duration of action for the combination therapy was significantly greater than the median duration of action for both the IB group and for the albuterol group on day 1, and significantly greater than the albuterol group on day 57. Median time to peak response was 1 h for the combination therapy. The median time to peak response ranged from 1 to 2 h for the IB group and from 30 min to 1 h for the albuterol group.
Subjects who had pulmonary function measured on all 4 test days provided FEVX values for analyses of persistence of bronchodilator action. For these subjects, baselines increased in all treatment groups, yet the mean increases were significant for the IB group only. Small decreases from day 1 peak response were seen on all follow-up test days for all three treatment groups. These decreases were statistically significant on days 29, 57, and 85 for the combination therapy group and on days 29 and 57 for the albuterol group. None of the changes were statistically significant for the IB group. There were no clinically or statistically significant differences in the decrease in response between combination therapy and albuterol, suggesting that the addition of IB to albuterol neither potentiated nor blocked the decrease seen with albuterol alone. Similar decreases were seen for AUC, especially over the first 4 h after treatment.
FVC results were similar to those seen with FEVX (Fig 2). The bronchodilator response in FEF25_75 to the combination therapy was also better than that for IB and albuterol. However, FEF25_75 results showed more variability and the differences were generally not statistically significant.
Table 5—FEV1 Response AUC (Liters-Hours) the First 4 h and Entire 8-hour Period After Therapy for Subjects Who Completed All Test Days
|IB and Albuterol (n=213)||IB(n=209)||Albuterol(n=207)|
|AUC 0-4 h|
|AUC 0-8 h|
Table 6—Mean Duration ofFEV1 Response of at Least 15% Above Baseline
|Day No.||IB and Albuterol (n=213)||IB(n=209)||Albuterol(n=207)|
|1||5 h||4 h (p=0.016)||3 h (p<0.001)|
|57||4 h||4 h (p=0.801)||2 h (p=0.018)|
|85||3 h||4 h(p=0.398)||3 h (p=0.181)|
Figure 2. Percent changes in mean FVC from test day baselines. C=combination (n=213), I=ipratropium (n=209), A=albuterol (n=207).
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