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Can Advair and Flovent Reduce Systemic Inflammation Related to Chronic Obstructive Pulmonary Disease (COPD)? A Multi-Center Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120978
Recruitment Status : Unknown
Verified April 2005 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : July 19, 2005
Last Update Posted : May 9, 2006
Information provided by:
University of British Columbia

Brief Summary:

Large population-based studies suggest that patients with chronic obstructive pulmonary disease (COPD) are 2 to 3 times at risk for cardiovascular mortality, which accounts for a large proportion of the total number of deaths. How COPD increases the risk of poor cardiovascular outcomes is largely unknown. However, there is growing evidence that persistent low-grade systemic inflammation is present in COPD and that this may contribute to the pathogenesis of atherosclerosis and cardiovascular disease among COPD patients. Inflammation and more specifically, C-reactive protein (CRP), has been linked with all stages of atherosclerosis, including plaque genesis, rupture and subsequent thrombo-fibrosis of vulnerable vessels. Recently, our group has demonstrated in a relatively small study that short-term inhaled corticosteroid (ICS) therapy can repress serum CRP levels in stable COPD patients. Conversely, withdrawal of ICS leads to a marked increase in serum CRP levels. Although very promising, these data cannot be considered definitive because the study was small in size and scope (N=41 patients). Additionally, this study did not address the potential effects of combination therapy with ICS and long-acting β2 agonists (LABA). This is an important short-coming because combination therapy of ICS and LABA have been shown to produce improved clinical outcomes over ICS monotherapy and is commonly used by clinicians in the treatment of moderate to severe COPD. We hypothesize that inhaled fluticasone (Flovent®) reduces systemic inflammation and that combination therapy (Advair®) is more effective than steroids alone in reducing systemic inflammation in COPD. In this proposal, we will implement a randomized controlled trial to determine whether ICS by themselves or in combination with LABAs can:

  1. reduce CRP levels in stable COPD patients and
  2. reduce other pro-inflammatory cytokines, which have been linked with cardiovascular morbidity and mortality such as interleukin-6 (IL-6) and monocyte chemoattractant protein-1 (MCP-1)

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Advair Drug: Flovent Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Advair - CRP Study
Study Start Date : December 2004
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Primary Outcome Measures :
  1. Change in serum C-reactive protein levels over 3 months between treatment groups.

Secondary Outcome Measures :
  1. changes in serum interleukin levels; quality of life; FEV1 between treatment groups

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients must have a clinical diagnosis of chronic obstructive pulmonary disease according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
  • Patients must have a cigarette smoking history of more than 10 pack-years
  • Patients must be clinically stable and at least 4 weeks from last acute exacerbation (and return to baseline level of symptoms)
  • Patients must have an FEV1 of less than 80% of predicted values with FEV1 to FVC ratio of less than 0.70 (post-bronchodilator values)
  • Men or women ≥ 45 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00120978

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Contact: Roxanne Rousseau, BS 604-977-9791
Contact: Don D Sin, MD 604-806-8395

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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2V 1P9
Contact: Gladys Wolters, BS    403-943-3292   
Principal Investigator: Gordon Ford, MD         
Principal Investigator: Robert Cowie, MD         
Links Clinic Recruiting
Edmonton, Alberta, Canada, T5G 3G6
Contact: Jill Edwards, BS    780-913-4240   
Principal Investigator: Warren Ramesh, MD         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Heidi Haupt, BS    (780) 407-7591   
Principal Investigator: Eric Wong, MD         
Grey Nuns Hospital Recruiting
Edmonton, Alberta, Canada, T6L 5X8
Contact: Jennifer Barchard, BS    780.450.7178   
Principal Investigator: Lyle Melenka, MD         
Lethbridge Regional Hospital Recruiting
Lethbridge, Alberta, Canada, T1J 1W5
Contact: Kathy Duce, BS    403-388-6031   
Principal Investigator: Eric Wilde, MD         
Wetaskiwin Lung Laboratory Recruiting
Wetaskiwin, Alberta, Canada, T9A 3B8
Contact: Teena Rossiter, BS    780.352.7085   
Principal Investigator: Ernest York, MD         
Canada, British Columbia
Lion's Gate Hospital Recruiting
North Vancouver, British Columbia, Canada, V7L 2N3
Contact: Anju Mainra, BS    : 604.649.5852   
Principal Investigator: Raj Mainra, MD         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 3J5
Contact: Linda Hui, BS    604.875.5697   
Principal Investigator: Mark Fitzgerald, MD         
St. Paul' Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Roxanne Rousseau, BS    604-977-9791   
Principal Investigator: Paul Man, MD         
Principal Investigator: Don Sin, MD         
Canada, Saskatchewan
Royal University Hospita Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Janet Baron, BS    306.966.7871   
Principal Investigator: Darcy Marciniuk, MD         
Sub-Investigator: John Reid, MD         
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Don Sin, MD University of British Columbia
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00120978    
Other Study ID Numbers: SC0100141
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: May 9, 2006
Last Verified: April 2005
Keywords provided by University of British Columbia:
Clinical Trial; C-reactive protein; fluticasone; salmeterol
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents