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Effects of Advair® in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation
This study is not yet open for participant recruitment.
Verified by Laval University, September 2007
First Received: September 17, 2007   No Changes Posted
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

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • To determine, in patient with COPD presenting with an acute exacerbation that can be treated at home, if the relapse rate at one month is equivalent for both treatments. [ Time Frame: September 2009 ]

Secondary Outcome Measures:
  • To compare lung function and dyspnea score improvement 10 days post-treatment. [ Time Frame: September 2009 ]
  • To determine the systemic and sputum inflammatory marker modulations after 10 days of treatment and 30 days following the randomization. [ Time Frame: September 2009 ]

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
Criteria

Inclusion Criteria:

  • diagnosis of COPD
  • history of 15 pack-years or more of cigarette smoking
  • evidence of irreversible obstruction (FEV1<70% of predicted value, ratio FEV1/FVC<70%, and improvement of FEV1of less than 20% after bronchodilator in previous respiratory tests done when they were stable)
  • current medication: LABA (Oxeze, Serevent, Symbicort, Advair)

Exclusion Criteria:

  • history of asthma or atopy
  • need of being hospitalized
  • use of oral or intravenous steroid within the preceding 30 days
  • history of multiresistant bacterial infection, bronchiectasis or recent COPD exacerbation (< 6 weeks) or diabetes.
  • oxygen-dependant COPD patients or patients previously known with hypercapnia (PCO2>45 mmHg) at steady state
  • use of high doses of Advair (more than 50/500 bid) or Symbicort (more than 12/400 bid)
  • known cardiac arrhythmia such as atrial fibrillation, supraventricular tachycardia or paroxysmal auricular tachycardia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531791

Contacts
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

Locations
Canada, Quebec
Hôpital Laval, Institut universitaire de cardiologie et de pneumologie
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
GlaxoSmithKline
Investigators
Principal Investigator: Julie Milot, MD PhD Hôpital Laval, Institut universitaire de cardiologie et de pneumologie
  More Information

No publications provided

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

Keywords provided by Laval University:
COPD
exacerbation
fluticasone
salmeterol
steroid

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 02, 2009