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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2005 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00120978
First received: July 11, 2005
Last updated: May 8, 2006
Last verified: April 2005
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Advair
Drug: Flovent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Advair - CRP Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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

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

Estimated Enrollment: 250
Study Start Date: December 2004
Estimated Study Completion Date: August 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120978

Contacts
Contact: Roxanne Rousseau, BS 604-977-9791 RRousseau@mrl.ubc.ca
Contact: Don D Sin, MD 604-806-8395 dsin@mrl.ubc.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2V 1P9
Contact: Gladys Wolters, BS    403-943-3292    Gladys.Wolters@CalgaryHealthRegion.ca   
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    jilledwards@shaw.ca   
Principal Investigator: Warren Ramesh, MD         
Grey Nuns Hospital Recruiting
Edmonton, Alberta, Canada, T6L 5X8
Contact: Jennifer Barchard, BS    780.450.7178    JBarchar@cha.ab.ca   
Principal Investigator: Lyle Melenka, MD         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Heidi Haupt, BS    (780) 407-7591    hhaupt@ualberta.ca   
Principal Investigator: Eric Wong, MD         
Lethbridge Regional Hospital Recruiting
Lethbridge, Alberta, Canada, T1J 1W5
Contact: Kathy Duce, BS    403-388-6031    kduce@mail.chr.ab.ca   
Principal Investigator: Eric Wilde, MD         
Wetaskiwin Lung Laboratory Recruiting
Wetaskiwin, Alberta, Canada, T9A 3B8
Contact: Teena Rossiter, BS    780.352.7085    teena@incentre.net   
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    mainra@shaw.ca   
Principal Investigator: Raj Mainra, MD         
St. Paul' Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Roxanne Rousseau, BS    604-977-9791    RRousseau@mrl.ubc.ca   
Principal Investigator: Paul Man, MD         
Principal Investigator: Don Sin, MD         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 3J5
Contact: Linda Hui, BS    604.875.5697    lindahui@interchange.ubc.ca   
Principal Investigator: Mark Fitzgerald, MD         
Canada, Saskatchewan
Royal University Hospita Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Janet Baron, BS    306.966.7871    janetbaron@shaw.ca   
Principal Investigator: Darcy Marciniuk, MD         
Sub-Investigator: John Reid, MD         
Sponsors and Collaborators
University of British Columbia
GlaxoSmithKline
Investigators
Principal Investigator: Don Sin, MD University of British Columbia
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00120978     History of Changes
Other Study ID Numbers: SC0100141, SC0100141
Study First Received: July 11, 2005
Last Updated: May 8, 2006
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Clinical Trial; C-reactive protein; fluticasone; salmeterol

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

ClinicalTrials.gov processed this record on August 20, 2014