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| Sponsors and Collaborators: |
Laval University GlaxoSmithKline |
|---|---|
| Information provided by: | Laval University |
| ClinicalTrials.gov Identifier: | NCT00531791 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: prednisone group Drug: Advair group |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Effects of Fluticasone/Salmeterol (Advair®) in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2009 |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
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.
|
| 2: Experimental |
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Julie Milot, MD PhD | 418-656-4747 | julie.milot@crhl.ulaval.ca |
| Contact: Julie Parent, PhD | 418-656-8711 ext 2913 | julie.parent@crhl.ulaval.ca |
| Canada, Quebec | |
| Hôpital Laval, Institut universitaire de cardiologie et de pneumologie | |
| Québec, Quebec, Canada, G1V 4G5 | |
| Principal Investigator: | Julie Milot, MD PhD | Hôpital Laval, Institut universitaire de cardiologie et de pneumologie |
More Information
| Study ID Numbers: | SCO-110754 |
| Study First Received: | September 17, 2007 |
| Last Updated: | September 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00531791 History of Changes |
| Health Authority: | Canada: Health Canada |
|
COPD exacerbation fluticasone salmeterol steroid |
|
Anti-Inflammatory Agents Prednisone Amoxicillin Salmeterol Antineoplastic Agents, Hormonal Hormone Antagonists Albuterol Respiration Disorders Hormones, Hormone Substitutes, and Hormone Antagonists Clavulanic Acids Amoxicillin-Potassium Clavulanate Combination Hormones |
Glucocorticoids Terbutaline Anti-Bacterial Agents Lung Diseases, Obstructive Ipratropium Respiratory Tract Diseases Moxifloxacin Lung Diseases Clavulanic Acid Fluticasone Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
|
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Antineoplastic Agents Respiration Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Glucocorticoids |
Hormones Pharmacologic Actions Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Lung Diseases Pulmonary Disease, Chronic Obstructive |