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Changes in Measures of Symptoms and Pulmonary Function During the Week Preceding an Exacerbation in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) FREE TO VIEW

Donald P. Tashkin, MD; Stephen I. Rennard, MD; Jennifer McElhattan, MS; Ubaldo J. Martin, MD
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University of California, Los Angeles, CA

Chest. 2010;138(4_MeetingAbstracts):798A. doi:10.1378/chest.10061
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PURPOSE: Changes in symptoms and pulmonary function before a COPD exacerbation are not well defined. In this post hoc analysis of data from a study in patients with COPD, changes from baseline in symptoms and pulmonary function during the week preceding the initial COPD exacerbation were assessed.

METHODS: Data were from a randomized, double-blind, multicenter 12-month study (N=1964) (NCT00206167; Drugs. 2009;69:549) in patients with moderate to very severe COPD aged ≥40 years. Data were combined from all treatment groups: twice-daily budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) 320/9 μg, BUD/FM pMDI 160/9 μg, FM dry powder inhaler (DPI) 9 μg, and placebo. Exacerbations were defined as worsening of COPD requiring oral corticosteroids (OCS) and/or hospitalization. Patients recorded dyspnea, cough, and sputum scores (derived from the Breathlessness, Cough, and Sputum Scale [BCSS; each scored on a 0-4 scale with higher scores indicating worse symptoms]), peak expiratory flow (PEF; L/min), and nighttime rescue medication use (inhalations/night) via diary. Mean changes from baseline in those variables were assessed during the 7 days preceding the patient’ s first exacerbation.

RESULTS: Tattersfield plots showed progressive worsening from baseline in mean dyspnea scores during the 7 days preceding COPD exacerbation; similar results were observed for cough and sputum scores. Mean change in dyspnea score overall during the 7 days was approximately 0.35 units, exceeding the predefined criteria for a minimal important difference (≥0.2-unit difference). Similar patterns of worsening were observed for PEF and nighttime rescue medication use during the 7 days preceding COPD exacerbation.

CONCLUSION: The results from this analysis show that COPD exacerbations are preceded by at least 7 days of worsening COPD symptoms and pulmonary function.

CLINICAL IMPLICATIONS: Substantial worsening in COPD symptoms and pulmonary function is observed before occurrence of a COPD exacerbation based on OCS treatment and/or hospitalization. Further research is needed to determine the threshold for changes in symptom-related variables that may be associated with a COPD exacerbation and whether such changes may help in predicting COPD exacerbations.

DISCLOSURE: Donald Tashkin, Grant monies (from industry related sources) This study was funded by AstraZeneca LP. Stephen I Rennard has received grant monies from Almirall, AstraZeneca, Biomark, Centocor, GSK, IFSH, Lorillard, Novartis, Pfizer, Philip Morris, Roche.; Shareholder Ubaldo J. Martin is a shareholder of AstraZeneca stocks.; Employee Jennifer McElhattan and Ubaldo J. Martin are employees of AstraZeneca; Consultant fee, speaker bureau, advisory committee, etc. Stephen I Rennard is a consultant to Abbott, Able Associations, Almirall, Almirall/Forest, Altana, Anthera, APT Pharma/Britnall, Aradigm, AstraZeneca, Boehringer Ingelheim, Britnall and Nicolini, Defined Health, Dunn Group, Eaton Associates, Gerson, GSK, Infomed, Johnson & Johnson, KOL Connection, Leerink Swan, MedaCorp, Mpex, Novartis, Otsuka, Pfizer, Propagate, Pulmatrix, Quintiles, Roche, Scimed, TargeGen, Theravance, United Biosource, Vantage Point, VantagePoint Mgmt; and on the Advisory Board of Abbott, Almirall, Boehringer Ingelheim, COPDForum, Dey, GSK, Novartis, Nycomed, Nycomed/Strategicare, Pfizer, Pharmaxis, Schering-Plough, TargeGen.; Other Stephen I Rennard is a speaker for ACCP, AstraZeneca, Novartis, Network for Continuing Ed, Pfizer, SOMA, Creative Educational Concept, France Foundation. Donald P Tashkin has received grant support (administered through his university), fees for consulting/advisory boards, and/or honoraria for speaking from Boehringer Ingelheim, Pfizer, AstraZeneca, GSK, Schering-Plough, Novartis, Teva, and Dey Labs.; No Product/Research Disclosure Information

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