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Markers of disease severity in chronic obstructive pulmonary disease

Markers of disease severity in chronic obstructive pulmonary disease

Markers of disease severity in chronic obstructive pulmonary

Pulmonary Pharmacology & Therapeutics 19 (2006) 189–199 www.elsevier.com/locate/ypupt Markers of disease severity in chronic obstructive pulmonary disease Luigi G. Franciosi a, *, Clive P. Page b , Bartolome R. Celli c , Mario Cazzola b,d , Michael J. Walker e , Meindert Danhof a , Klaus F. Rabe f , Oscar E. Della Pasqua a,g a Gorlaeus Laboratories, Leiden/Amsterdam Center for Drug Research, Leiden University, Einsteinweg 55, 2300 RA, Leiden, The Netherlands b Sackler Institute of Pulmonary Pharmacology, King’s College, London, UK c St Elizabeth’s Hospital, Tufts University, Boston, MA, USA d Department of Respiratory Medicine, A. Cardarelli Hospital, Naples, Italy e Department of Pharmacology and Therapeutics, University of British Columbia, Vancouver, Canada f Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands g Clinical Pharmacology and Discovery Medicine, GlaxoSmithKline, Greenford, UK Received 1 February 2005; revised 11 May 2005; accepted 12 May 2005 Abstract Background and objectives: Diagnosis and assessment of treatment effect in chronic obstructive pulmonary disease (COPD) have relied primarily on the examination of a complex set of symptoms and the use of spirometry. However, these methods require long periods of assessment to determine whether patients show clinically relevant improvements after intervention. We therefore wanted to determine how existing clinical and laboratory measures change with COPD severity and identify disease markers that can serve as better endpoints for diagnosis and assessment of COPD progression and treatment effect. Methods: Using standard COPD keywords and terms, we searched PubMed, ISI Web of Science, and Cochrane Review databases for retrospective and prospective clinical studies published since 1966. We identified 652 studies (nZ146,255) from 1978 to September 2003 based on the availability of spirometric and demographic data, investigation of possible markers, absence of acute exacerbations and comorbidities, and the withdrawal of standard COPD medication. Central tendencies and dispersions of subject baseline measures were collected according to study sample size, smoking status, and mild, moderate and severe COPD stages. A fixed effect meta-analysis was then conducted on each measure at various disease stages. Results: Arterial oxygen tension, sputum neutrophils and IL-8, and serum TNF-a and C-Reactive Protein showed a trend toward separation between COPD stages. Other measures such as pack-years and St George’s Respiratory Questionnaire only distinguished between disease and disease-free states. Conclusions: We observed little separation between disease stages for many measures used in COPD diagnosis and clinical trials. This demonstrates the poor sensitivity of such endpoints to define a patient’s clinical status and to quantify treatment effect. Therefore, we recommend that longitudinal studies and disease modelling be the primary methods for assessing whether potential markers of disease progression can be used for COPD diagnosis and clinical trials. q 2005 Elsevier Ltd. All rights reserved. Keywords: COPD; Disease progression; Biological marker; Mathematical model 1. Introduction * Corresponding author. Tel.: C44 20 8966 5765; fax: C44 20 8966 2123. E-mail address: l.franciosi@lacdr.leidenuniv.nl (L.G. Franciosi). 1094-5539/$ - see front matter q 2005 Elsevier Ltd. All rights reserved. doi:10.1016/j.pupt.2005.05.001 Chronic obstructive pulmonary disease (COPD) is a respiratory syndrome associated with a progressive, nonreversible limitation to airflow and abnormal inflammatory responses involving the small airways [1]. Current diagnosis of COPD involves an assessment of smoking and occupational history as well as recording of symptoms such as cough, sputum and dyspnea. However, due to poor public awareness of this disease and the overlap of symptoms with other comorbidities, many patients are not diagnosed until later when the disease has made a significant impact on their quality of life [2,3]. For many years, spirometry has been the only means of confirming and monitoring airflow obstruction. Since

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