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Effects of Advair® in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation

NCT00531791 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2011-06-17

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

prednisone group

Patients in the prednisone group will receive prednisone 40 mg per day with concomitant placebo diskus 2 inhalations twice a day for 10 days. All patients will receive oral antibiotics for 10 days, which will include moxifloxacin (Avelox®) 400 mg die or amoxicillin/clavulanate (Clavulin®) 875mg bid and short-acting bronchodilators (Ventolin®, Bricanyl®, Atrovent®) as needed.

DRUG

Advair group

Patients in the second group will receive Advair® 50/500 ug 2 inhalations twice daily with placebo pills once a day for 10 days (twice the regular dosage). All patients will receive oral antibiotics for 10 days, which will include moxifloxacin (Avelox®) 400 mg die or amoxicillin/clavulanate (Clavulin®) 875mg bid and short-acting bronchodilators (Ventolin®, Bricanyl®, Atrovent®) as needed.

Sponsors & Collaborators

Principal Investigators

  • Julie Milot, MD PhD · Hôpital Laval, Institut universitaire de cardiologie et de pneumologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00531791 on ClinicalTrials.gov