The EFFECT trial: evaluating exacerbations, biomarkers, and safety outcomes with two dose levels of fluticasone propionate/formoterol in COPD

• DOI: 10.2147/copd.s93375
• Publication Date: 2015-11-12T22:38:16Z
• Authors: Alberto Papi; Paul Jones; Kirsten McAulay; Tammy McIver; Sanjeeva Dissanayake; Prashant Dalvi
• Keywords: Fluticasone propionate; Formoterol Fumarate; Fluticasone

Abstract: Inhaled corticosteroid/long-acting β 2 -agonist combination therapy is recommended in chronic obstructive pulmonary disease (COPD) patients at high risk of exacerbations. The EFFECT (Efficacy Fluticasone propionate/FormotErol COPD Treatment) trial a Phase III, 52-week, randomized, double-blind study to evaluate the efficacy and safety two doses fluticasone propionate/formoterol compared formoterol monotherapy with FEV 1 ≤50% predicted history primary endpoint annualized rate moderate severe Secondary endpoints include pre-dose , EXACT-PRO (EXAcerbations Chronic Tool – Patient-Reported Outcome)-defined exacerbations, St George’s Respiratory Questionnaire for COPD, Assessment Test, EXACT-Respiratory Symptoms total score. Lung-specific biomarkers (surfactant protein D CC chemokine ligand-18) will be measured subset explore their relationship other clinical indices predictive utility. Pneumonia diagnosed per criteria defined by British Thoracic Society community acquired pneumonia guideline, primarily radiological confirmation and, additionally, using when chest radiograph cannot obtained. Serial measurements serum potassium, vital signs electrocardiograms, 24-hour Holter monitoring, urinary cortisol measurement performed addition conventional assessments. Keywords: disease, flutiform, inhaled corticosteroids, long-acting