Clinical research study
Comparing COPD Treatment: Nebulizer, Metered Dose Inhaler, and Concomitant Therapy

https://doi.org/10.1016/j.amjmed.2006.07.043Get rights and content

Abstract

Purpose

Patients using albuterol and ipratropium for treating chronic obstructive pulmonary disease (COPD) can use either nebulizers or metered dose inhalers. This study compared the 2 methods of delivering medication and the concomitant use of both nebulizer and inhaler, with respect to health-related quality of life, patient symptoms, and efficacy.

Subjects and Methods

Patients over 50 years old with COPD were randomized into 3 groups: nebulizer, inhaler, or concomitant treatment. Quality of life was assessed using the St. George’s Respiratory Questionnaire at baseline, and at 6 and 12 weeks. Other efficacy measurements at these time-points included pre- and post-dose forced expired volume in 1 second (FEV1). Symptom scores and peak flow measurements were recorded in patient diaries.

Results

Of 140 patients enrolled, 126 completed at least one post-baseline assessment. At week 6, both groups using a nebulizer achieved statistically significant improvements from baseline in questionnaire symptoms, and the concomitant treatment group had clinically and statistically significant improvement in total questionnaire score. At week 12, the concomitant group still maintained significant improvement in symptom sub-scores. The 3 groups showed little change over time in peak flow or FEV1, with no significant difference among groups. Both groups using a nebulizer had significant improvement over time in diary symptom scores, although differences between groups were not significant.

Conclusions

Patients using combined nebulizer therapy morning and night with mid-day inhaler use had the most statistically significant improvements in quality of life indices. This concomitant regimen provides the additional symptom relief offered by a nebulizer with the convenience of an inhaler when patients are away from home.

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:

  • Nebulizer (albuterol plus ipratropium unit dose solution; DuoNeb) only, 1 unit dose vial 4 times daily

  • Inhaler (albuterol plus ipratropium; Combivent) only, 2 puffs 4 times daily

  • 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.

References (16)

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