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      Improving the quality of life in patients with chronic obstructive pulmonary disease: focus on indacaterol

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          Chronic obstructive pulmonary disease (COPD) is a common disease in the general population and it places a considerable burden on patients, with the disease negatively affecting quality of life. In practice, patients with COPD generally seek medical attention because of symptoms, particularly breathlessness, and the resulting physical limitations, which affect the health-related quality of life (HR-QOL) in patients. The defining feature of COPD is airflow limitation that causes air trapping and increased hyperinflation as the ventilation rate increases during physical effort. Hyperinflation causes or worsens breathlessness as breathing becomes inefficient, with the end result being an avoidance of physical exertion and a cycle of increasing dyspnea caused by inactivity and deconditioning, with deleterious effects on HR-QOL. Current published guidelines for COPD state that the goals of pharmacologic therapy should be to control symptoms, improve health status and exercise tolerance, and reduce the frequency of COPD exacerbations. Effective and sustained bronchodilation has emerged as a key strategy for improving dyspnea and ability to exercise. As there is no cure for COPD, a major goal of treatment and of research into new therapies is to improve HR-QOL in COPD patients.


          More recently, indacaterol, an inhaled ultra-long-acting β 2-agonist (24-hour action), has been approved in many countries at different doses (between 75 and 300 μg once daily) for treatment of patients with stable but symptomatic COPD. The aim of this review was to explore once-daily indacaterol clinical data as related to improvement in HR-QOL in COPD. Indacaterol studies have shown significant improvements in lung function of COPD patients, and these improvements have also translated into clinically meaningful improvements in patient symptoms and HR-QOL.

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          Most cited references 30

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          Interpreting thresholds for a clinically significant change in health status in asthma and COPD.

          Health status (or Health-Related Quality of Life) measurement is an established method for assessing the overall efficacy of treatments for asthma and chronic obstructive pulmonary disease (COPD). Such measurements can indicate the potential clinical significance of a treatment's effect. This paper is concerned with methods of estimating the threshold of clinical significance for three widely used health status questionnaires for asthma and COPD: the Asthma Quality of Life Questionnaire, Chronic Respiratory Questionnaire and St George's Respiratory Questionnaire. It discusses the methodology used to obtain such estimates and shows that the estimates appear to be fairly reliable; ie. for a given questionnaire, similar estimates may be obtained in different studies. These empirically derived thresholds are all mean estimates with confidence intervals around them. The presence of these confidence intervals affects the way in which the thresholds may be used to draw inferences concerning the clinical relevance of clinical trial results. A new system of judging the magnitude of clinically significant results is proposed. Finally, an attempt is made to translate these thresholds into scenarios that illustrate what a clinically significant change with treatment may mean to an individual patient.
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            Health status measurement in chronic obstructive pulmonary disease.

             G Jones (2001)
            Health status measurement is a common feature of studies in chronic obstructive pulmonary disease (COPD). This review assesses recent evidence for the validity of these measurements and their role as measures of the overall impact of the disease on the patient's daily life and wellbeing. It reviews the mostly widely used COPD specific questionnaires and examines the contribution that they make to an assessment of the overall effect of treatment. Finally, it addresses the question of how symptomatic benefit may be assessed in individual patients in routine practice.
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              Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium.

               J Swales,  Charles Fogarty,   (2010)
              Indacaterol is the first once-daily, long-acting inhaled beta(2)-agonist bronchodilator studied in patients with chronic obstructive pulmonary disease (COPD). To demonstrate greater efficacy of indacaterol versus placebo on FEV(1) at 24 hours post dose (trough) after 12 weeks, to compare efficacy with placebo and tiotropium, and to evaluate safety and tolerability over 26 weeks. Patients with moderate-to-severe COPD were randomized to double-blind indacaterol 150 or 300 microg or placebo, or open-label tiotropium 18 microg, all once daily, for 26 weeks. The primary efficacy outcome was trough FEV(1) at 12 weeks. Additional analyses (not adjusted for multiplicity) included transition dyspnea index (TDI), health status (St George's Respiratory Questionnaire [SGRQ]), and exacerbations. Serum potassium, blood glucose, and QTc interval were measured. A total of 1,683 patients (age, 63.3 yr; post-bronchodilator FEV(1), 56% predicted; FEV(1)/FVC, 0.53) were randomized to the four treatment arms. Trough FEV(1) at Week 12 increased versus placebo by 180 ml with both indacaterol doses and by 140 ml with tiotropium (all P < 0.001 vs. placebo). At Week 26, for indacaterol 150/300 microg, respectively, versus placebo, TDI increased (1.00/1.18, P < 0.001) and SGRQ total score decreased (-3.3/-2.4, P < 0.01); corresponding results with tiotropium were 0.87 (P < 0.001) for TDI and (-1.0, P = not significant) for SGRQ total score. The incidence of adverse events, low serum potassium, high blood glucose, and prolonged QTc interval was similar across treatments. Indacaterol was an effective once-daily bronchodilator and was at least as effective as tiotropium in improving clinical outcomes for patients with COPD. Clinical trial registered with (NCT 00463567).

                Author and article information

                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                14 February 2013
                : 8
                : 89-96
                S Carolina Pharmaceutical Research, Alliance Biomedical Group International, Spartanburg, SC, USA
                Author notes
                Correspondence: Gregory J Feldman S Carolina Pharmaceutical Research, Alliance Biomedical Group International, 141 Harold Fleming Court, Spartanburg, SC 29303, USA, Tel +1 864 515 0092, Fax +1 864 515 0094, Email gfeld3232@
                © 2013 Feldman, publisher and licensee Dove Medical Press Ltd

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.


                Respiratory medicine

                copd, long-acting β2-agonist, bronchodilation, airflow limitation


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