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COPD/ASTHMA TRIALS ( Last modified 1October 2006)

1) Adjustable maintenance dosing with budesonide/formoterol compared with fixed-dose salmeterol/fluticasone in moderate to severe asthma.Curr Med Res Opin. 2004;20(2):225-40

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BACKGROUND: Current asthma guidelines recommend that patients are educated to adjust their medication according to their asthma severity using physician-guided self-management plans. However, many patients take a fixed dose of their controller medication and adjust their reliever medication according to asthma symptoms. OBJECTIVES: This study examined whether asthma control improved if patients adjusted the maintenance dose of budesonide/formoterol (Symbicort Turbuhaler* 160/4.5 microg) according to asthma severity compared with traditional fixed dosing (FD) regimens. METHODS: Symptomatic patients with asthma (n = 658, mean symptom score 1.5, mean inhaled corticosteroids 735 microg/day, mean forced expiratory volume in 1 second [FEV(1)] 84% predicted) were randomised after 2 weeks' run-in to either: budesonide/formoterol adjustable maintenance dosing (AMD), budesonide/formoterol FD or salmeterol/fluticasone (Seretide Diskus dagger 50/250 microg) FD. In a 4-week double-blind period, both budesonide/formoterol AMD and FD groups received two inhalations twice daily (bid) and salmeterol/fluticasone FD patients received one inhalation bid. In the following 6-month open extension, both FD groups continued with the same treatment. Patients in the AMD group with well-controlled asthma stepped down to one inhalation bid; others continued with two inhalations bid. All AMD patients could increase to four inhalations bid for 7-14 days if symptoms worsened. All patients used terbutaline or salbutamol for symptom relief throughout. The primary variable was the odds of achieving a well-controlled asthma week (WCAW). RESULTS: The odds ratio for achieving a WCAW did not differ between the FD regimens; however, during the open period, budesonide/formoterol AMD increased the odds of achieving a WCAW vs. budesonide/formoterol FD (odds ratio 1.335; 95% CI: 1.001, 1.783; p = 0.049) despite a 15% reduction in average study drug use. Budesonide/formoterol AMD patients had a lower exacerbation rate over the study: 40% lower vs. salmeterol/fluticasone FD (p = 0.018); 32% lower vs. budesonide/formoterol FD (NS). During the double-blind period, there were no clinically relevant differences between the budesonide/formoterol FD and salmeterol/fluticasone FD groups. Budesonide/formoterol AMD patients used less reliever medication in the open extension: 0.58 vs. 0.92 occasions/day for budesonide/formoterol FD (p = 0.001) and 0.80 occasions/day for salmeterol/fluticasone FD (p = 0.011). CONCLUSIONS: Adjustable maintenance dosing with budesonide/formoterol provides more effective asthma control by reducing exacerbations and reliever medication usage compared with fixed-dose salmeterol/fluticasone.

2) Systemic corticosteroids in chronic obstructive pulmonary disease: An overview of Cochrane systematic reviews. Respir Med. 2006 Sep 6


Chronic obstructive pulmonary disease (COPD) is characterized by symptoms of cough, sputum and breathlessness, which become worse during acute exacerbations. The airway inflammation associated with COPD has led to trials of the effect of systemic corticosteroids in COPD assessed in two Cochrane systematic reviews. In stable COPD, compared with placebo, oral corticosteroid treatment increased mean FEV(1) by 53ml and mean 12-min walking distance by 29m, but at an increased risk of any drug-related adverse event (OR 7.8). In acute exacerbations, oral corticosteroid treatment decreased the chance of treatment failure (OR 0.48), improved mean FEV(1) at 72h by 140ml and improved arterial blood gases, but increased the risk of drug-related adverse events (OR 2.3). Thus, treatment of stable and acute exacerbations of COPD with systemic corticosteroids results in statistically significant average benefits, but at an increased risk of adverse events. In stable COPD, there is little support for the use of systemic corticosteroid treatment, as data on long-term outcomes are lacking. For acute exacerbations, the evidence to support the use of systemic corticosteroids is stronger, but further research is required to define the optimum dose, route and duration.

3) Incidence of COPD in a Cohort of Young Adults According to the Presence of Chronic Cough and Phlegm. Am J Respir Crit Care Med. 2006 Sep 28


RATIONALE: The few prospective studies aimed at assessing the incidence of COPD in relation to the presence of chronic cough / phlegm have given contrasting results. OBJECTIVES: To assess the incidence of COPD in a cohort of young adults, in order to test whether chronic cough / phlegm and dyspnoea are independent predictors of COPD. METHODS: An international cohort of 5,002 non-asthmatic subjects (20-44 years) with normal lung function (FEV1/FVC ratio >/=70%) from 12 countries was followed from 1991-1993 to 1999-2002 in the frame of the European Community Respiratory Health Survey II. Incident cases of COPD were those who had a FEV1/FVC ratio <70% at the end of the follow-up, but did not report having had a doctor diagnosis of asthma during the follow-up. MAIN RESULTS: The incidence rate of COPD was 2.8 cases/1,000/year (95%CI: 2.3 to 3.3). Chronic cough / phlegm was an independent and statistically significant predictor of COPD (IRR=1.85; 95%CI: 1.17 to 2.93) after adjusting for smoking habits and other potential confounders, whereas dyspnoea was not associated with the disease (IRR=0.98; 95%CI: 0.64 to 1.50). Subjects who reported chronic cough / phlegm both at baseline and at the follow-up had a nearly three-fold increased risk of developing COPD with respect to asymptomatic subjects (IRR=2.88; 95%CI: 1.44 to 5.79). CONCLUSIONS: The incidence of COPD is substantial also in young adults. The presence of chronic cough / phlegm identifies a sub-group of subjects with a high risk of developing COPD, independently of smoking habits.

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