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

Figures & data

Figure 1 Study design.

Notes: ^aIn subsets of patients. ^bAdditional safety assessments include serial serum potassium, heart rate, blood pressure, and QT interval pre-dose and over 60 minutes post-dose.
Abbreviations: CAT, COPD Assessment Test; EXACT, EXAcerbations of Chronic pulmonary disease Tool; R, randomization; SGRQ-C, St George’s Respiratory Questionnaire for COPD; V, visit; bid, twice a day.

Table 1 Summary of study endpoints

Primary endpoint

Annualized rate of moderate and severe COPD exacerbations during the treatment period

Key secondary endpoints

Average pre-dose FEV1 during the treatment period

Annualized rate of COPD exacerbations (based on the EXACT criteria) during the treatment period

Time to first moderate or severe COPD exacerbation

Change in SGRQ-C score from baseline to week 6, 23, and 52

Change in COPD Assessment Test score from baseline to week 6, 23, and 52

Mean daily rescue medication use during the treatment period

Percentage change in awakening-free nights during the treatment period

Average E-RS dyspnea score during the treatment period

Average E-RS total score during the treatment period

Exploratory endpoints

Change in SP-D and CCL-18 from baseline to week 6 in a subset of patients

Abbreviations: EXACT, EXAcerbations of Chronic pulmonary disease Tool; E-RS, EXACT-Respiratory Symptoms; SGRQ-C, St George’s Respiratory Questionnaire for COPD; SP-D, surfactant protein D; CCL-18, CC chemokine ligand-18.