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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00531791
First received: September 17, 2007
Last updated: June 16, 2011
Last verified: June 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare lung function and dyspnea score improvement 10 days post-treatment. [ Time Frame: September 2009 ] [ Designated as safety issue: No ]
  • To determine the systemic and sputum inflammatory marker modulations after 10 days of treatment and 30 days following the randomization. [ Time Frame: September 2009 ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: November 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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.
Experimental: 2 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 and older
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)

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 (not applicable if absence of multi-resistant bacterial infection has been proved by a negative expectoration culture in the previous 6 months), 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00531791

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

Responsible Party: Dre Julie Milot, Hôpital Laval
ClinicalTrials.gov Identifier: NCT00531791     History of Changes
Other Study ID Numbers: SCO-110754, CER 20222
Study First Received: September 17, 2007
Last Updated: June 16, 2011
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
COPD
exacerbation
fluticasone
salmeterol
steroid

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone, salmeterol drug combination
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014