New Study Design To Test Novel COPD Drug

New Study Design To Test Novel COPD Drug

shutterstock_170413661Researchers from Germany recently designed a longitudinal prospective non-intervention study (DACCORD) aimed at assessing the efficacy of a new drug called long-acting anticholinergic glycopyrronium bromide for the treatment of chronic obstructive pulmonary disease.

The research study methodology and design entitled “The Prospective Non-Interventional DACCORD Study in the National COPD Registry in Germany: design and methods,” was recently published in the journal BMC Pulmonary Medicine.

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Estimations in Germany reveal that 13.3% of the population aged over 40 years are diagnosed with the disease. COPD increases with age up to 40.4% in men older than 70 years.

The Global Initiative for Obstructive Lung Disease (GOLD) defines COPD as “airflow limitation that is not fully reversible and usually progressive.”  Although there is strong evidence that COPD causes decline in lung function (FEV1) and symptoms such as breathlessness, activity limitations, exacerbations and co-morbidities, evidence on the natural history of COPD under real life treatment conditions in the community (i.e. elderly patients) is lacking.

In this regard, Peter Kardos from the Group Practice and Centre for Allergy, Respiratory and Sleep Medicine, Red Cross Maingau Hospital in Frankfurt, Germany and colleagues, designed DACCORD, an ongoing 2 to 4-year non-interventional longitudinal prospective cohort study that is being conducted on 6,000 patients at 500 centers in Germany.

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The study’s primary endpoints are patient-related outcomes (PRO’s), treated in both primary and/or secondary care. Further assessments include exacerbations, lung function, adherence and side effects of the new compound. The study will consist of a group A: standard care with glycopyrronium containing regimen, vs. group B: standard care regimen without glycopyrronium. Following a baseline visit, subjects are to be followed-up for at least 2 years in approximately three-month intervals. Afterward, two additional visits are planned at 3 and 4 years, respectively.

Furthermore, the researchers hope that the design of the study will enable an evaluation either according to the old GOLD I-IV or the new GOLD ABCD grading system, thus permitting proper comparison of the results.

Patient enrollment for the DACCORD trial started in November 2012, and the researchers are expecting to announce the final results of primary analyses in the first quarter of 2016. During 2015, the team will provide interim one-year data.

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