Comparison of fluticasone/formoterol with budesonide/formoterol pMDI in adults with moderate to severe persistent asthma: Results from a 12-week randomized controlled trial.

BACKGROUND: Combination therapy of inhaled corticosteroid/long acting ß2-agonist (ICS/LABA) is the cornerstone of managing asthmatics who are uncontrolled with low-medium dose of ICS. The novel ICS/LABA combination of fluticasone propionate and formoterol (flu/form) provides potent anti-inflammatory and rapid bronchodilatory effect. This randomized, multi-centre, double-blind study compared the efficacy and safety of flu/form (125/6 mcg BD; Maxiflo®) with the well-established budesonide/formoterol combination (bud/form 200/6 mcg BD), both delivered through a pressurized metered dose inhaler (pMDI) in patients with moderate to severe persistent asthma over 12 weeks. METHODS: This study enrolled patients between 18 and 65 years. The primary end-point was to demonstrate non-inferiority for the mean change in the pre-dose morning peak expiratory flow values (PEF). The secondary end-points included lung function assessments, number of symptom-free days and nights, rescue medication use, day-and night-time symptom scores and safety evaluation. RESULTS: Two hundred and thirty-two patients were randomized to either flu/form (n = 117) or bud/form (n = 115). At the end of 12 weeks, flu/form was non-inferior to bud/form with regards to the primary end-point of morning PEF (48.07 L/min vs. 49.03 L/min, p > 0.05). These improvements were statistically significant (p < 0.0001) vs baseline. Similar improvements were observed between the two groups for secondary efficacy end-points including FEV1, symptom-free nights, rescue medication use, day-and night-time symptom scores (p > 0.05). Flu/form exhibited a safety profile comparable to that of bud/form. CONCLUSION: Fluticasone/formoterol combination administered through a pMDI is as efficacious and well-tolerated as budesonide/formoterol and offers a new therapeutic option for patients with moderate to severe persistent asthma.

Evaluation of HS-CRP and Lipid Profile in COPD.

INTRODUCTION: COPD is a major public health problem. More than 50 % of the patients of COPD die because of some cardiovascular event. Traditionally, the risk of CVD is assessed by the presence of dyslipidaemia. Recently, HS-CRP has emerged as a novel risk factor for the CVD assessment. In this study, we assessed the patients of COPD for CVD with HS-CRP and lipid indicators. MATERIAL AND METHODS: Forty Five diagnosed patients of COPD and 45 age, sex, and BMI matched healthy controls were enrolled for the study after the institutional ethical committee's clearance was obtained. The fasting serum samples of the study subjects were evaluated for the lipid profile and HS-CRP. RESULTS: There was no statistical difference in the lipid profile in the two groups, while HS-CRP was significantly raised in the COPD patients. On applying kappa statistics, we found a poor agreement between the lipid parameters and HS-CRP in estimating the risk for CVD. This underlines the independent importance of HS-CRP in the CVD assessment of COPD patients. DISCUSSION: GOLD has described COPD as a systemic chronic inflammatory disease which involves the lung and the distant organs by the emissary of the systemic inflammation, which is also an antecedent to cardiovascular diseases. COPD is a systemic inflammatory disease which is underlined by this study. But the derangement of the lipid indicators is not statistically significant. This suggests the addition of HS-CRP in the assessment of the COPD patients for CVD. This further needs to be ascertained in a large prospective model. CONCLUSION: COPD is systemic inflammatory disease, but there is hardly any derangement of the lipid indicators.

Association between periodontal disease and chronic obstructive pulmonary disease: a reality or just a dogma?

BACKGROUND: In the past few years, the association between chronic obstructive pulmonary disease (COPD) and periodontal disease has been promulgated. The present study is aimed at determining the association between these two diseases. METHODS: This observational study includes 501 individuals consisting of 102 patients (case group) having COPD and 399 individuals as controls. Individuals in the case group were well-functioning and ambulatory patients having COPD as determined by their history and their values of forced expiratory volume in 1 second (FEV1) and forced vital capacity. Periodontal status was evaluated by the following five indices: 1) plaque index; 2) oral hygiene index (OHI); 3) gingival index (GI); 4) probing depth (PD); and 5) clinical attachment level (CAL). Lung function test was performed by all the patients (case group), who were then graded into mild, moderate, severe, and very severe. RESULTS: Preliminary analysis was performed to identify the covariates in this study. Individuals in the case group had significantly higher CAL, PD, and OHI (P <0.0001) compared with the control group after adjusting for covariates. A significant negative correlation was observed between FEV1 values and CAL, PD, and GI, thus indicating a trend in which severity of lung obstruction increased as these periodontal indices worsened. CONCLUSION: Although the present study cannot ascertain causal association, it provides substantial evidence that poor periodontal health is associated with obstructive lung disease.