A randomized trial of once-daily fluticasone furoate/vilanterol or vilanterol versus placebo to determine effects on arterial stiffness in COPD

Figures

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  Figure 1. CONSORT diagram. Notes: aTwo patients were randomized erroneously (did not receive study medication but were included in the ITT population); hence, these patients were counted in both the randomized population and the screen and run-in failure population; b14 patients were excluded from the ITT population (due to issues of good clinical practice not associated with this study, in one center); however, these patients were included in the safety population and the ITT sensitivity population; cstopping criteria = protocol-defined stopping criteria; dpatients were considered to have completed the study if they attended the last clinic visit (visit 6, day 168), had a follow-up contact, and did not withdraw. Abbreviations: AE, adverse event; FF, fluticasone furoate; ITT, intent-to-treat; VI, vilanterol.

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  Figure 2. Adjusted mean change from baseline in aPWV (m/s). Notes: n2 = number of patients with analyzable data at the given time point (day 28, day 84, day 126, or day 168). Analyzed using a repeated measures model with terms for treatment, baseline aPWV, COPD exacerbation history, smoking status at screening, geographic region, gender, age, day, day by baseline aPWV interaction, and day by treatment interaction. Abbreviations: aPWV, aortic pulse wave velocity; CI, confidence interval; COPD, chronic obstructive pulmonary disease; FF, fluticasone furoate; LS, least squares; SE, standard error; VI, vilanterol.

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  Figure 3. Adjusted treatment differences compared with placebo for lung function and health outcomes scores. Notes: (A) Trough FEV1 on days 84 and 168, analyzed using a repeated measures model with terms for treatment, baseline FEV1, COPD exacerbation history, geographic region, day, day by baseline FEV1 interaction, and day by treatment interaction. (B) IC on days 84 and 168, analyzed using a repeated measures model with terms for treatment, baseline IC, COPD exacerbation history, geographic region, day, day by baseline IC interaction, and day by treatment interaction. (C) Rescue medication use throughout the 168-day treatment period, analyzed using an analysis of covariance model with covariates of treatment, baseline mean number of occasions of rescue medication use, COPD exacerbation history, and geographic region. (D) SGRQ total score, analyzed using a repeated measures model with terms for treatment, baseline SGRQ total score, COPD exacerbation history, geographic region, day, day by baseline SGRQ total score interaction, and day by treatment interaction. (E) CAT, on days 84 and 168, analyzed using a repeated measures model in terms of treatment, baseline CAT score, COPD exacerbation…