Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Advair - CRP Study
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)
Status | Recruiting |
Enrollment | 250 |
Est. completion date | August 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Canada | Grey Nuns Hospital | Edmonton | Alberta |
Canada | Links Clinic | Edmonton | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | Lethbridge Regional Hospital | Lethbridge | Alberta |
Canada | Lion's Gate Hospital | North Vancouver | British Columbia |
Canada | Royal University Hospita | Saskatoon | Saskatchewan |
Canada | St. Paul' Hospital | Vancouver | British Columbia |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Canada | Wetaskiwin Lung Laboratory | Wetaskiwin | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | GlaxoSmithKline |
Canada,
Sin DD, Man SF, Marciniuk DD, Ford G, FitzGerald M, Wong E, York E, Mainra RR, Ramesh W, Melenka LS, Wilde E, Cowie RL, Williams D, Rousseau R; ABC (Advair, Biomarkers in COPD) Investigators. Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? Study protocol for a randomized controlled trial [NCT00120978]. BMC Pulm Med. 2006 Feb 6;6:3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum C-reactive protein levels over 3 months between treatment groups. | |||
Secondary | changes in serum interleukin levels; quality of life; FEV1 between treatment groups |
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