86
Views
70
CrossRef citations to date
0
Altmetric
Original Research

The lung function profile of once-daily tiotropium and olodaterol via Respimat® is superior to that of twice-daily salmeterol and fluticasone propionate via Accuhaler® (ENERGITO® study)

, , , , , & show all
Pages 193-205 | Published online: 03 Feb 2016

Figures & data

Figure 1 Study design.

Notes: Treatment periods are 6 weeks and washout periods are 3 weeks. A–D refer to treatment groups.
Abbreviations: R, randomization; S, screening.
Figure 1 Study design.

Figure 2 Patient disposition.

Notes: aNine patients did not complete any treatment; bincludes lack of efficacy; ccompleting ≥1 treatment arm.
Abbreviation: AE, adverse event.
Figure 2 Patient disposition.

Table 1 Demographic and baseline patient characteristics (treated population)

Table 2 Adjusted mean FEV1 AUC responses after 6 weeks of treatment (full analysis set)

Table 3 Adjusted mean FEV1 AUC0–12, AUC0–24, and AUC12–24 responses after 6 weeks of treatment, showing the treatment differences (full analysis set)

Figure 3 Adjusted mean 24-hour FEV1 profile after 6 weeks of treatment (full analysis set).

Abbreviations: bid, twice daily; F, fluticasone propionate; FEV1, forced expiratory volume in 1 second; O, olodaterol; qd, once daily; S, salmeterol; T, tiotropium.
Figure 3 Adjusted mean 24-hour FEV1 profile after 6 weeks of treatment (full analysis set).

Table 4 Peak0–3 FEV1 response at study Day 1 and Day 43 and trough FEV1 responses after 6 weeks of treatment (full analysis set)

Table 5 Peak0–3 FEV1 response at study Day 1 and Day 43 and trough FEV1 responses after 6 weeks of treatment, showing the differences between treatments (full analysis set)

Figure 4 Adjusted mean 24-hour FVC profile after 6 weeks of treatment (full analysis set).

Abbreviations: bid, twice daily; F, fluticasone propionate; FVC, forced vital capacity; O, olodaterol; qd, once daily; S, salmeterol; T, tiotropium.
Figure 4 Adjusted mean 24-hour FVC profile after 6 weeks of treatment (full analysis set).

Table 6 Summary of AEs (treated population)

Table S1 Additional exclusion criteria

Table S2 Adjusted mean FVC AUC0–12, AUC0–24, and AUC12–24 responses after 6 weeks of treatment: treatment differences (full analysis set)

Table S3 Adjusted mean FVC AUC0–3, trough FVC, and peak0–3 FVC responses after 6 weeks of treatment: treatment differences (full analysis set)