Effects of Advair® in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
Short course of steroids in COPD exacerbation improves FEV1 and decreases the relapse rate.
However, some concerns remain about using systemic steroids for all patients with acute
exacerbation. Their short-term advantages may be outweighed by the occurrence of adverse side
effects such as hyperglycemia, which is difficult to manage on an outpatient basis. In this
context, the possibility of treating patients with COPD exacerbation with inhaled steroids
having less systemic adverse effects is interesting. The objectives are to compare relapse
rate, lung function, the severity of dyspnea and, systemic and sputum inflammatory markers in
outpatients with acute COPD exacerbations treated with fluticasone/salmeterol (Advair®) or
oral prednisone for 10 days. The hypothesis is that Advair® is as effective as prednisone in
treatment of outpatients with COPD exacerbation. The primary endpoint is to determine if the
relapse rate at one month is equivalent for both treatments. The secondary endpoints are to
compare lung function and dyspnea score and, systemic and sputum inflammatory markers
modulation after 10 days of both treatments. We will recruit 30 outpatients in each group
from our COPD clinic. Patients will receive prednisone (40mg/day) with placebo diskus or
Advair® 50/500ug 2 inhalations bid (twice the regular dose) with placebo pills for 10 days.
All patients will receive antibiotics and short-acting bronchodilators as needed. We expect
to demonstrate that the improvement of lung function, dyspnea, inflammatory markers and
relapse rate are equivalent in both treatments suggesting that Advair® could be a good
alternative to prednisone for patients with steroid-induced hyperglycemia.