Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Advair - CRP Study
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)


Options:
A: Arm Label: Symbicort+TIO; Type: ACTIVE_COMPARATOR; Interventions: Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug) | Arm Label: Spiriva® + Placebo Turbuhaler; Type: ACTIVE_COMPARATOR; Interventions: Drug: Spiriva (tiotropium bromide 18ug) | Intervention Type: DRUG; Name: Symbicort (budesonide/formoterol turbuhaler 320/9ug); Assigned to Arm(s): Symbicort+TIO | Intervention Type: DRUG; Name: Spiriva (tiotropium bromide 18ug); Assigned to Arm(s): Spiriva® + Placebo Turbuhaler
B: Intervention Type: DRUG; Name: Budesonide/formoterol pMDI; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Formoterol Turbuhaler; Assigned to Arm(s): N/A
C: Intervention Type: DRUG; Name: Advair; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Flovent; Assigned to Arm(s): N/A
D: Arm Label: Symbicort then Formoterol then Placebo; Type: EXPERIMENTAL; Interventions: Drug: budesonide/formoterol Turbuhaler 320/9µg, Drug: formoterol Turbuhaler 9µg, Other: Placebo | Arm Label: Formoterol then Symbicort then Placebo; Type: EXPERIMENTAL; Interventions: Drug: budesonide/formoterol Turbuhaler 320/9µg, Drug: formoterol Turbuhaler 9µg, Other: Placebo | Arm Label: Placebo then Formoterol then Symbicort; Type: PLACEBO_COMPARATOR; Interventions: Drug: budesonide/formoterol Turbuhaler 320/9µg, Drug: formoterol Turbuhaler 9µg, Other: Placebo | Intervention Type: DRUG; Name: budesonide/formoterol Turbuhaler 320/9µg; Assigned to Arm(s): Formoterol then Symbicort then Placebo, Placebo then Formoterol then Symbicort, Symbicort then Formoterol then Placebo | Intervention Type: DRUG; Name: formoterol Turbuhaler 9µg; Assigned to Arm(s): Formoterol then Symbicort then Placebo, Placebo then Formoterol then Symbicort, Symbicort then Formoterol then Placebo | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Formoterol then Symbicort then Placebo, Placebo then Formoterol then Symbicort, Symbicort then Formoterol then Placebo

Answer: C