Chest
Volume 115, Issue 4, April 1999, Pages 966-971
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Clinical Investigations
Bronchodilators
The Combination of Ipratropium and Albuterol Optimizes Pulmonary Function Reversibility Testing in Patients With COPD

https://doi.org/10.1378/chest.115.4.966Get rights and content

Study objectives

To determine whether the combination of ipratropium bromide and albuterol results in greater and more consistent pulmonary function test (PFT) response rates than ipratropium bromide or albuterol alone in patients with COPD.

Design

Retrospective review of two recently completed 3-month, randomized, double-blind, parallel, multicenter, phase III trials.

Setting

Outpatient.

Patients

A total of 1,067 stable patients with COPD.

Interventions

Ipratropium bromide (36 μg qid), albuterol base (180 μg qid), or an equivalent combination of ipratropium bromide and albuterol sulfate (42 μg and 240 μg qid, respectively).

Measurements and results

PFT response rates were analyzed using 12% and 15% increases in FEV1 compared with baseline values and were measured in the various treatment groups on days 1, 29, 57, and 85 in these trials. Regardless of whether a 12% or a 15% increase in FEV1 was used to define a positive response, an equivalent combination of ipratropium bromide and albuterol sulfate was superior to the individual agents (p < 0.05; all comparisons within 30 min). In addition, a 15% or more increase in FEV1 was seen in > 80% of patients who received the combination of ipratropium and albuterol sulfate during the initial PFT and continued to be observed 3 months after initial testing.

Conclusions

Use of a combination of ipratropium bromide and albuterol sulfate is superior to the individual agents in identifying PFT reversibility in patients with COPD.

Section snippets

Materials and Methods

The PFT response rates obtained during two recently completed randomized, multicenter, double-blind, parallel group, phase III clinical trials comparing the safety and efficacy of a combination of ipratropium and albuterol to either ipratropium alone or albuterol alone were reviewed11 (data on file; Boehringer Ingelheim Pharmaceuticals Inc). Informed consent was obtained from each subject who participated in these trials.

The study groups consisted of outpatients of either sex who were 40 years

Patient Demographics

A total of 1,067 patients were enrolled in the two trials with 852 patients completing the entire study. The demographic and baseline characteristics of the 1,067 randomized patients are presented in Table 1. These patients had moderate to severe COPD with an overall FEV1 of 0.95 ± 0.41 L, which corresponds to an FEV1 percent predicted of 35.6 ± 13.6% for the group as a whole.

FEV1 Response Rate on Individual Test Days

As shown in Table 1, mean baseline values for FEV1 were comparable among the three groups and remained comparable as

Discussion

Our study confirms the hypothesis that the combination of ipratropium and albuterol results in greater PFT response rates than ipratropium or albuterol alone in patients with COPD. Specifically, the data demonstrate that whether a significant PFT response is defined as a 12% or a 15% increase in FEV1 compared with baseline values, the combination of ipratropium plus albuterol is superior to the individual agents. In addition, the superior PFT response rate observed with the combination of

References (19)

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Drs. Dorinsky, Reisner, Menjoge, Serby, and Witek were, at the time of this study, employed by Boehringer Ingelheim Pharmaceuticals, Inc, maker of the Combivent brand of ipratropium bromide and albuterol.

Currently at Glaxo Wellcome, Research Triangle Park, NC.

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