Routine Nebulized Ipratropium and Albuterol Together Are Better Than Either Alone in COPD: Results

In: COPD

18 Mar 2014

Analysis of covariance with baseline as a covariate was used to compare the bronchodilator response to the three treatments. Other terms of the model were the interactions of treatment, center, and treatment-by-center. Friedman’s rank test was used to compare duration of action. A p value < 0.05 was considered significant. A subject’s data were excluded from the analysis if the criteria for protocol definition for COPD were not met or if the theophylline level was >10 fxg/mL at the day 1 baseline. This resulted in excluding 18 patients from analysis, four from IB, seven from albuterol, and seven from the combination. An intent-to-treat analysis produced results similar to those based on the above exclusions.
Results
Subject Disposition
The number of randomized subjects and number of subjects who withdrew are summarized in Table 2. The withdrawal rates are similar in the three treatment groups. The most frequent adverse events leading to withdrawal were lower respiratory tract symptoms, except the withdrawals in the albuterol group in which the most common event was nausea. cialis professional online

Efficacy
The baseline FEV1 values for the three groups were comparable on each of the 4 test days and were stable over the course of the study (Table 3). The p values represent the differences between the treatment group and the group treated with the combination. On each of the 4 test days, subjects in each treatment group had clinically significant bronchodilator responses as shown by increases in FEV1 from baselines of at least 15% (Fig 1). The response to the combination was superior to the response to either drug given singly, especially during the first 4 h of testing each day.
On each of the 4 test days, the mean peak response for the combination therapy was significantly greater than either of its components. The combination means at peak ranged from 17 to 28% greater than IB means, and from 17 to 26% greater than the albuterol means (Table 4). The mean peak percent increases in FEV1 on the 4 test days were from 34 to 37% for the combination, 27 to 29% for IB, and 27 to 31% for albuterol.

Figure 1. Percent changes in mean FEV1 from test day baselines. C=combination (n=213), I=ipratropium (n=209), A=albuterol (n=207).

Figure 1. Percent changes in mean FEV1 from test day baselines. C=combination (n=213), I=ipratropium (n=209), A=albuterol (n=207).

Table 2—Randomized and Withdrawn Subjects (Percent)

IB and Albuterol IB Albuterol Overall
Total randomized and treated 222 214 216 652
Withdrawn because ofworsening of disease under study 9(4.1) 8 (3.7) 8 (3.7) 25 (3.8)
Adverse event 12 (5.4) 4(1.9) 10 (4.6) 26 (4.0)
Protocol violation 7 (3.2) 3(1.4) 1 (0.5) 11(1.7)
Unavailable for follow-up 1 (0.5) 3(1.4) 0 (0.0) 4 (0.6)
Withdrawal of consent 6 (2.7) 4 (1.9) 6(2.8) 16 (2.5)
Other reasons 1 (0.5) 1 (0.5) 0 (0.0) 2 (0.3)
Total 36 (16.2) 23 (10.07) 25(11.6) 84 (12.9)
Completed all test days 186 (83.8) 191 (89.3) 191 (88.4) 568 (87.1)

Table 3—Baseline FEV1 Values (Liters) for Each Study Day for Subjects Who Completed All Test Days

Day No. IB and Albuterol (n=213) IB(n=209) Albuterol(n=207)
1 0.90 0.88 0.91
(p—0.455) (p=0.744)
29 0.92 0.92 0.92
(p=0.927) (p—0.996)
57 0.90 0.93 0.93
(p=0.590) (p=0.571)
85 0.91 0.91 0.91
(p=0.989) (p=0.963)

Table 4—Mean Peak FEV2 Increase (Liters) for Each Study Day for Subjects Who Completed All Test Days

Day No. IB and Albuterol (n=213) IB(n=209) Albuterol(n=207)
1 0.37 0.29 0.31
(p<0.001) (p—0.002)
29 0.34 0.29 0.29
(p=0.004) (p=0.013)
57 0.34 0.27 0.27
(p<0.001) (p<0.001)
85 0.34 0.27 0.29
(p<0.001) (p=0.001)

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