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Effect of Inhaled Corticosteroids on Respiratory Function Tests and Airway Inflammation in Stable Chronic Obstructive Pulmonary Disease

A Randomised, Double-Blind, Placebo-Controlled Clinical Trial

  • Clinical Pharmacodynamics
  • Published:
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Abstract

Objective

To evaluate the efficacy of inhaled budesonide 400μg twice daily in the treatment of stable chronic obstructive pulmonary disease (COPD).

Design and Setting

Randomised, placebo-controlled, double-blind, parallel-group study.

Patients

40 patients with stable COPD.

Interventions

The patients were randomised to receive either inhaled budesonide 400μg twice daily or placebo in the same form for 12 weeks. Spirometry and sputum cell analysis were performed both at baseline and post-treatment.

Results

There were no significant differences between groups at baseline. At the end of the study, there was a trend to a decreased total sputum cell count in the group receiving budesonide, with a reduced proportion of neutrophils (p < 0.001) and an increased proportion of macrophages. The increase from baseline in the proportion of macrophages reached significance (p < 0.001) when compared with that in the placebo group [5.9% versus 0.4%, 95% confidence interval (CI) of difference 3.4 to 7.6%]. A significant increase compared with controls was also determined for forced vital capacity (9.0% versus 1.2%, p < 0.001, 95% CI of difference 4.6 to 10.9%) and forced expiratory volume in 1 second (7.4% versus 0.7%, p < 0.01, 95% CI of difference 2.1 to 11.2%).

Conclusions

The efficacy of inhaled corticosteroids in COPD remains controversial. In this study, it was determined that inhaled budesonide improves airway inflammation and pulmonary function. Although these effects do not represent a clinically significant improvement, inhaled corticosteroids may be useful in COPD because of their superior adverse effect profile.

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Notes

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Authors and Affiliations

  1. Chest Diseases Department, Faculty of Medicine, Atatürk University, Erzurum, Turkey

    A. Mirici & Y. Bektas

  2. Pharmacology Department, Faculty of Medicine, Atatürk University, Erzurum, Turkey

    G. Ozbakis

  3. Pathology Department, Faculty of Medicine, Atatürk University, Erzurum, Turkey

    Z. Erman

Authors
  1. A. Mirici
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  2. Y. Bektas
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  3. G. Ozbakis
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  4. Z. Erman
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Correspondence to A. Mirici.

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Mirici, A., Bektas, Y., Ozbakis, G. et al. Effect of Inhaled Corticosteroids on Respiratory Function Tests and Airway Inflammation in Stable Chronic Obstructive Pulmonary Disease. Clin. Drug Investig. 21, 835–842 (2001). https://doi.org/10.2165/00044011-200121120-00006

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  • DOI: https://doi.org/10.2165/00044011-200121120-00006

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