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Characterization of the Bronchodilatory Dose Response to Indacaterol in Patients with Chronic Obstructive Pulmonary Disease Using Model-based Approaches by Didier Renard; Michael Looby; Benjamin Kramer; David Lawrence; David Morris; Donald R Stanski is a Medicine article available to read on EtoBox.
What is Characterization of the Bronchodilatory Dose Response to Indacaterol in Patients with Chronic Obstructive Pulmonary Disease Using Model-based Approaches about?
Background: Indacaterol is a once-daily long-acting inhaled β 2 -agonist indicated for maintenance treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD). The large inter-patient and inter-study variability in forced expiratory volume in 1 second (FEV 1 ) with bronchodilators makes determination of optimal doses difficult in conventional dose-ranging studies. We considered alternative methods of analysis. Methods: We utilized a novel modelling approach to provide a robust analysis of the bronchodilatory dose response to indacaterol. This involved pooled analysis of study-level data to characterize the bronchodilatory dose response, and nonlinear mixed-effects analysis of patient-level data to characterize the impact of baseline covariates. Results: The study-level analysis pooled summary statistics for each steady-state visit in 11 placebo-controlled studies. These study-level summaries encompassed data from 7476 patients at indacaterol doses of 18.75-600 μg once daily, and showed that doses of 75 μg and above achieved clinically important improvements in predicted trough FEV 1 response. Indacaterol 75 μg achieved 74% of the maximum effect on trough FEV 1 , an
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- Author
- Didier Renard; Michael Looby; Benjamin Kramer; David Lawrence; David Morris; Donald R Stanski
- Publisher
- BioMed Central; Springer (Biomed Central Ltd.); [London]: Current Science Ltd, 2000-; [London]: BioMed Central; Springer Science and Business Media LLC (ISSN 1465-9921)
- Published
- 2011
- Language
- EN
- Field
- Medicine (Health Sciences)