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Original Articles

Fluticasone furoate/vilanterol once daily improves night-time awakenings in asthma patients with night symptoms: Post hoc analyses of three randomized controlled trials

, MD, , MD, , PhD, , MD, , MMathStat, , PhD & , MSc show all
Pages 890-897 | Received 10 May 2017, Accepted 13 Jul 2017, Published online: 24 Jul 2018

Figures & data

Table 1. Patient demographics and baseline characteristics for individuals enrolled in each of the three Phase III clinical studies examined by this post hoc analysis.

Figure 1. Differences between treatments for change from baseline number of additional symptom-free 24-hour periods, days and nights for patients enrolled in Bleecker et al. (A), Bernstein et al. (B), and O'Byrne et al. (C). Bleecker et al. (HZA106827/NCT01165138, conducted over 12 weeks) [Citation5]; Bernstein et al. (HZA116863/NCT01686633, conducted over 12 weeks) [Citation7]; O'Byrne et al. (HZA106829/NCT01134042, conducted over 24 weeks) [Citation6]. BD, twice daily; CI, confidence interval; FF, fluticasone furoate; FP, fluticasone propionate; OD, once daily; VI, vilanterol.

Figure 1. Differences between treatments for change from baseline number of additional symptom-free 24-hour periods, days and nights for patients enrolled in Bleecker et al. (A), Bernstein et al. (B), and O'Byrne et al. (C). Bleecker et al. (HZA106827/NCT01165138, conducted over 12 weeks) [Citation5]; Bernstein et al. (HZA116863/NCT01686633, conducted over 12 weeks) [Citation7]; O'Byrne et al. (HZA106829/NCT01134042, conducted over 24 weeks) [Citation6]. BD, twice daily; CI, confidence interval; FF, fluticasone furoate; FP, fluticasone propionate; OD, once daily; VI, vilanterol.

Figure 2. Adjusted mean change from baseline in percentage of symptom-free nights, by Week for patients enrolled in Bleecker et al. (A), Bernstein et al. (B), and O'Byrne et al. (C). Bleecker et al. (HZA106827/NCT01165138, conducted over 12 weeks) [Citation5]; Bernstein et al. (HZA116863/NCT01686633, conducted over 12 weeks) [Citation7]; O'Byrne et al. (HZA106829/NCT01134042, conducted over 24 weeks) [Citation6]. BD, twice daily; CI, confidence interval; FF, fluticasone furoate; FP, fluticasone propionate; LS, least squares; NTA, night-time awakening; OD, once daily; VI, vilanterol.

Figure 2. Adjusted mean change from baseline in percentage of symptom-free nights, by Week for patients enrolled in Bleecker et al. (A), Bernstein et al. (B), and O'Byrne et al. (C). Bleecker et al. (HZA106827/NCT01165138, conducted over 12 weeks) [Citation5]; Bernstein et al. (HZA116863/NCT01686633, conducted over 12 weeks) [Citation7]; O'Byrne et al. (HZA106829/NCT01134042, conducted over 24 weeks) [Citation6]. BD, twice daily; CI, confidence interval; FF, fluticasone furoate; FP, fluticasone propionate; LS, least squares; NTA, night-time awakening; OD, once daily; VI, vilanterol.

Figure 3. Percentage of patients with 100% symptom-free nights for patients enrolled in Bleecker et al. (A), Bernstein et al. (B), and O'Byrne et al. (C). Bleecker et al. (HZA106827/NCT01165138, conducted over 12 weeks) [Citation5]; Bernstein et al. (HZA116863/NCT01686633, conducted over 12 weeks) [Citation7]; O'Byrne et al. (HZA106829/NCT01134042, conducted over 24 weeks) [Citation6]. BD, twice daily; CI, confidence interval; FF, fluticasone furoate; FP, fluticasone propionate; OD, once daily; VI, vilanterol.

Figure 3. Percentage of patients with 100% symptom-free nights for patients enrolled in Bleecker et al. (A), Bernstein et al. (B), and O'Byrne et al. (C). Bleecker et al. (HZA106827/NCT01165138, conducted over 12 weeks) [Citation5]; Bernstein et al. (HZA116863/NCT01686633, conducted over 12 weeks) [Citation7]; O'Byrne et al. (HZA106829/NCT01134042, conducted over 24 weeks) [Citation6]. BD, twice daily; CI, confidence interval; FF, fluticasone furoate; FP, fluticasone propionate; OD, once daily; VI, vilanterol.

Table 2. Additional symptom-free nights per week after treatment compared with baseline in patients who had at least one night with symptoms at baseline.

Figure 4. Cumulative incidence curve of time to completion of seven consecutive symptom-free nights for patients enrolled in Bleecker et al. (A), Bernstein et al. (B), and O'Byrne et al. (C). Bleecker et al. (HZA106827/NCT01165138, conducted over 12 weeks) [Citation5]; Bernstein et al. (HZA116863/NCT01686633, conducted over 12 weeks) [Citation7]; O'Byrne et al. (HZA106829/NCT01134042, conducted over 24 weeks) [Citation6]. BD, twice daily; CI, confidence interval; FF, fluticasone furoate; FP, fluticasone propionate; NTA, night-time awakening; OD, once daily; VI, vilanterol.

Figure 4. Cumulative incidence curve of time to completion of seven consecutive symptom-free nights for patients enrolled in Bleecker et al. (A), Bernstein et al. (B), and O'Byrne et al. (C). Bleecker et al. (HZA106827/NCT01165138, conducted over 12 weeks) [Citation5]; Bernstein et al. (HZA116863/NCT01686633, conducted over 12 weeks) [Citation7]; O'Byrne et al. (HZA106829/NCT01134042, conducted over 24 weeks) [Citation6]. BD, twice daily; CI, confidence interval; FF, fluticasone furoate; FP, fluticasone propionate; NTA, night-time awakening; OD, once daily; VI, vilanterol.
Supplemental material

Edward_Kerwin_et_al._Supplementary_Appendix.docx

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