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      Once-daily indacaterol 75 μg in moderate- to-severe COPD: results of a Phase IV study assessing time until patients’ perceived onset of effect

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          Abstract

          Background

          Indacaterol 75 μg once daily is a long-acting β 2 agonist approved for maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD). The purpose of this study was to evaluate patients’ perception of onset of effect with a single dose.

          Methods

          In this double-blind, crossover, Phase IV study, 40 patients were randomized to receive a single dose of indacaterol 75 μg or placebo via a dry powder inhaler device. The primary variable was time until patient’s perception of onset of effect, using a simple self-administered (nonvalidated) questionnaire that patients answered at nine protocol-specified time points. Exploratory variables included change in forced expiratory volume in 1 second (FEV 1) and change in percent predicted FEV 1 from predose to postdose (determined 60–75 minutes postdose).

          Results

          The least-squares mean time to patient’s perception of onset of effect was 25.4 minutes and 23.9 minutes for indacaterol and placebo, respectively. There was no significant effect for treatment, period, or sequence on the time to patient’s perception. In addition, no statistically significant differences between treatments were observed for patient’s global satisfaction with onset of effect and global expectation of treatment adherence. For the exploratory variable change in FEV 1 from predose to postdose, indacaterol showed superiority over placebo with a clinically relevant least-squares mean treatment difference of 0.12 L ( P<0.0001). There was little or no association between patient’s perception of time to onset of effect and change in FEV 1, or change in percent predicted FEV 1. Both treatments were well tolerated.

          Conclusion

          A single dose of indacaterol 75 μg did not separate from placebo in terms of patient perception of onset, although there was an improvement in FEV 1 for indacaterol compared with placebo. Development and use of a validated questionnaire may be needed to address the inconsistency in evaluating this patient-related outcome.

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          Most cited references 14

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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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            The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes.

            To improve the clinical measurement of dyspnea, we developed a baseline dyspnea index that rated the severity of dyspnea at a single state and a transition dyspnea index that denoted changes from that baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task, and magnitude of effort. At the baseline state, dyspnea was rated in five grades from 0 (severe) to 4 (unimpaired) for each category. The ratings for each of the three categories were added to form a baseline focal score (range, 0 to 12). At the transition period, changes in dyspnea were rated by seven grades, ranging from -3 (major deterioration), to +3 (major improvement). The ratings for each of the three categories were added to form a transition focal score (range, -9 to +9). In 38 patients tested with respiratory disease, interobserver agreement was highly satisfactory for both indexes. The baseline focal score had the highest correlation (r = 0.60; P less than 0.001) with the 12-minute walking distance (12 MW), while significant, but lower, correlations existed for lung function. For the transition focal score, there was a significant correlation only with the 12 MW (r = 0.33; p = 0.04). These results indicate that dyspnea can receive a direct clinical rating that provides important information not disclosed by customary physiologic tests.
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              Sample sizes for clinical trials with normal data.

               S Julious (2004)
              This article gives an overview of sample size calculations for parallel group and cross-over studies with Normal data. Sample size derivation is given for trials where the objective is to demonstrate: superiority, equivalence, non-inferiority, bioequivalence and estimation to a given precision, for different types I and II errors. It is demonstrated how the different trial objectives influence the null and alternative hypotheses of the trials and how these hypotheses influence the calculations. Sample size tables for the different types of trials and worked examples are given. Copyright 2004 John Wiley & Sons, Ltd.
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                Author and article information

                Journal
                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
                1176-9106
                1178-2005
                2014
                01 September 2014
                : 9
                : 919-925
                Affiliations
                [1 ]Midwest Chest Consultants, St Charles, MO, USA
                [2 ]North Carolina Clinical Research, Raleigh, NC, USA
                [3 ]Novartis Pharmaceuticals, East Hanover, NJ, USA
                [4 ]Charlotte Lung and Health Center, Charlotte, NC, USA
                Author notes
                Correspondence: Thomas M Siler, Midwest Chest Consultants, 330 First Capitol Drive, Suite 470, St Charles, MO, USA, Tel +1 63 6946 1650, Email thomas.siler.md@ 123456midwestchest.com
                Article
                copd-9-919
                10.2147/COPD.S67356
                4159068
                © 2014 Siler et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Original Research

                Respiratory medicine

                bronchodilator, long-acting, perceived onset of action, single dose

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