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

Abstract

Inhaled corticosteroid/long-acting β2-agonist combination therapy is recommended in chronic obstructive pulmonary disease (COPD) patients at high risk of exacerbations. The EFFECT (Efficacy of Fluticasone propionate/FormotErol in COPD Treatment) trial is a Phase III, 52-week, randomized, double-blind study to evaluate the efficacy and safety of two doses of fluticasone propionate/formoterol compared to formoterol monotherapy in COPD patients with FEV1 ≥50% predicted and a history of exacerbations. The primary endpoint is the annualized rate of moderate and severe exacerbations. Secondary endpoints include pre-dose FEV1, EXACT-PRO (EXAcerbations of Chronic pulmonary disease Tool - Patient-Reported Outcome)-defined exacerbations, St George's Respiratory Questionnaire for COPD, COPD Assessment Test, and EXACT-Respiratory Symptoms total score. Lung-specific biomarkers (surfactant protein D and CC chemokine ligand-18) will be measured in a subset of patients to explore their relationship to other clinical indices in COPD and their predictive utility. Pneumonia will be diagnosed per criteria defined by the British Thoracic Society community acquired pneumonia guideline, primarily by radiological confirmation and, additionally, using clinical criteria when a chest radiograph cannot be obtained. Serial measurements of serum potassium, vital signs and electrocardiograms, 24-hour Holter monitoring, and 24-hour urinary cortisol measurement will be performed in a subset of patients in addition to conventional safety assessments.

Authors+Show Affiliations

Department of Internal and CardioRespiratory Medicine, Research Centre on Asthma and COPD, University of Ferrara, Ferrara, Italy.Institute for Infection and Immunity, St George's, University of London, London, UK.Medical Science - Respiratory, Mundipharma Research Ltd, Cambridge, UK.Medical Operations, Mundipharma Research Ltd, Cambridge, UK.Data Management and Statistics, Mundipharma Research Ltd, Cambridge, UK.Medical Science - Respiratory, Mundipharma Research Ltd, Cambridge, UK.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26648706

Citation

Papi, Alberto, et al. "The EFFECT Trial: Evaluating Exacerbations, Biomarkers, and Safety Outcomes With Two Dose Levels of Fluticasone Propionate/formoterol in COPD." International Journal of Chronic Obstructive Pulmonary Disease, vol. 10, 2015, pp. 2431-8.
Papi A, Jones PW, Dalvi PS, et al. The EFFECT trial: evaluating exacerbations, biomarkers, and safety outcomes with two dose levels of fluticasone propionate/formoterol in COPD. Int J Chron Obstruct Pulmon Dis. 2015;10:2431-8.
Papi, A., Jones, P. W., Dalvi, P. S., McAulay, K., McIver, T., & Dissanayake, S. (2015). The EFFECT trial: evaluating exacerbations, biomarkers, and safety outcomes with two dose levels of fluticasone propionate/formoterol in COPD. International Journal of Chronic Obstructive Pulmonary Disease, 10, 2431-8. https://doi.org/10.2147/COPD.S93375
Papi A, et al. The EFFECT Trial: Evaluating Exacerbations, Biomarkers, and Safety Outcomes With Two Dose Levels of Fluticasone Propionate/formoterol in COPD. Int J Chron Obstruct Pulmon Dis. 2015;10:2431-8. PubMed PMID: 26648706.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The EFFECT trial: evaluating exacerbations, biomarkers, and safety outcomes with two dose levels of fluticasone propionate/formoterol in COPD. AU - Papi,Alberto, AU - Jones,Paul W, AU - Dalvi,Prashant S, AU - McAulay,Kirsten, AU - McIver,Tammy, AU - Dissanayake,Sanjeeva, Y1 - 2015/11/09/ PY - 2015/12/10/entrez PY - 2015/12/10/pubmed PY - 2016/9/22/medline KW - chronic obstructive pulmonary disease KW - flutiform KW - inhaled corticosteroids KW - long-acting β2-agonist SP - 2431 EP - 8 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 10 N2 - Inhaled corticosteroid/long-acting β2-agonist combination therapy is recommended in chronic obstructive pulmonary disease (COPD) patients at high risk of exacerbations. The EFFECT (Efficacy of Fluticasone propionate/FormotErol in COPD Treatment) trial is a Phase III, 52-week, randomized, double-blind study to evaluate the efficacy and safety of two doses of fluticasone propionate/formoterol compared to formoterol monotherapy in COPD patients with FEV1 ≥50% predicted and a history of exacerbations. The primary endpoint is the annualized rate of moderate and severe exacerbations. Secondary endpoints include pre-dose FEV1, EXACT-PRO (EXAcerbations of Chronic pulmonary disease Tool - Patient-Reported Outcome)-defined exacerbations, St George's Respiratory Questionnaire for COPD, COPD Assessment Test, and EXACT-Respiratory Symptoms total score. Lung-specific biomarkers (surfactant protein D and CC chemokine ligand-18) will be measured in a subset of patients to explore their relationship to other clinical indices in COPD and their predictive utility. Pneumonia will be diagnosed per criteria defined by the British Thoracic Society community acquired pneumonia guideline, primarily by radiological confirmation and, additionally, using clinical criteria when a chest radiograph cannot be obtained. Serial measurements of serum potassium, vital signs and electrocardiograms, 24-hour Holter monitoring, and 24-hour urinary cortisol measurement will be performed in a subset of patients in addition to conventional safety assessments. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/26648706/The_EFFECT_trial:_evaluating_exacerbations_biomarkers_and_safety_outcomes_with_two_dose_levels_of_fluticasone_propionate/formoterol_in_COPD_ L2 - https://dx.doi.org/10.2147/COPD.S93375 DB - PRIME DP - Unbound Medicine ER -