Clinical research studyComparing COPD Treatment: Nebulizer, Metered Dose Inhaler, and Concomitant Therapy
Section snippets
Study Objectives
The purpose of this study was to compare the impact on quality of life, patient symptoms, and other outcomes of maintenance treatment of COPD using a nebulizer versus an inhaler only or the concomitant use of a nebulizer and inhaler versus an inhaler only to deliver the same medication. The medication used was a combination of albuterol and ipratropium in the form of DuoNeb (Dey; Napa, California) for the nebulizer and Combivent (Boehringer Ingelheim Pharmaceuticals; Ridgefield, Connecticut)
Study Design
Patients were recruited into a 12-week, multi-center, single-blind, 3-arm, parallel-group, phase 4 study conducted in 2004. Study-eligible patients were randomized into one of 3 treatment groups, each allowing albuterol inhaler rescue medication as needed:
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Nebulizer (albuterol plus ipratropium unit dose solution; DuoNeb) only, 1 unit dose vial 4 times daily
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Inhaler (albuterol plus ipratropium; Combivent) only, 2 puffs 4 times daily
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Concomitant treatment involving nebulizer (morning and night) plus
Patient Sample and Demographics
A total of 140 patients were enrolled across 17 sites, with 126 patients (90%) completing at least one post-baseline assessment (the analytic population) and 97 (69%) finishing the entire study. The most common reason for early discontinuation was withdrawal of consent (56%). The analytic population was divided nearly evenly among the 3 treatment groups, with demographic characteristics similar in all 3 groups (Table 1).
Health-Related Quality of Life
Table 2 shows that quality of life, as measured by the questionnaire Total
Discussion
While randomized controlled trials have failed to show significant differences between nebulizers and inhalers for delivering bronchodilator therapy in their effects on lung function or respiratory symptoms,9 these trials had a number of limitations. Shortcomings included study populations restricted to those demonstrating ability to use the devices properly, failure to take patient preferences into account, and limited study of how long-term real-life use affected clinically important outcomes
Conclusions
In this naturalistic study, the most effective regimen for managing COPD and improving patient quality of life appeared to be the combined use of a nebulizer in the morning and at night, and an inhaler in the afternoon and evening. Although patients may consider use of an inhaler alone to be more convenient than using only a nebulizer, the combination of treatment modalities offers potential advantages. Such a regimen could provide the benefits of additional symptom relief offered by the
Acknowledgments
Support from Dey Laboratories, Napa, California was provided to fund the research reported in this manuscript and the preparation of the manuscript.
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