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Clinical InvestigationsCOUGHThe Breathlessness, Cough, and Sputum Scale: The Development of Empirically Based Guidelines for Interpretation
Section snippets
Design
Secondary analyses were performed on available, blinded data from 3,643 patients undergoing treatment during the course of three phase-IIIa, multicenter, multinational, randomized, double-blind, placebo-controlled clinical trials evaluating the safety and efficacy of sibenadet, a novel dual-dopamine D2 receptor/β2 adrenoreceptor agonist developed to treat bronchoconstriction and ameliorate respiratory symptoms in patients with COPD1415; two of the trials involved a 12-week treatment period (n =
Results
Of the 3,643 patients enrolled in the three trials, 2,971 patients were eligible for these secondary analyses based on the existence of data necessary for the analyses outlined above. Within this group, 1,348 patients had an exacerbation during the course of the trial, of whom 713 patients had BCSS data for use in these analyses. Demographic and clinical characteristics of the analytical sample are provided in Table 1. Mean baseline BCSS total score for the sample was 5.18±1.97 on the 12-point
Discussion
The purpose of this study was to develop guidelines for interpreting group-level changes in BCSS scores in clinical studies of COPD. A triangulation method was used, juxtaposing BCSS change scores by clinical indicators of treatment success commonly used in clinical practice and trials involving patients with COPD (physician and patient perception of treatment efficacy, FEV1, and SGRQ scores) along with statistical indicators of magnitude (percentage change and ES). Daily and weekly BCSS scores
BCSS
The BCSS was used in clinical trials as part of a patient's daily diary card. Below is a sample instruction page from the diary card.
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Cited by (0)
This study was supported by AstraZeneca Pharmaceuticals LP.
Dr. Jones and Dr. Goldman are employees of AstraZeneca.
Dr. Rennard has received research grant support, honoraria for speaking, and fees for consultancy from AstraZeneca. Neither he nor his family have any ownership position in AstraZeneca.