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. 2014 Aug 9:3:419.
doi: 10.1186/2193-1801-3-419. eCollection 2014.

The 24-h FEV1 time profile of olodaterol once daily via Respimat® and formoterol twice daily via Aerolizer® in patients with GOLD 2-4 COPD: results from two 6-week crossover studies

Gregory J Feldman  1 , Jonathan A Bernstein  2 , Alan Hamilton  3 , Michael C Nivens  4 , Lawrence Korducki  5 , Craig LaForce  6
Affiliations

The 24-h FEV1 time profile of olodaterol once daily via Respimat® and formoterol twice daily via Aerolizer® in patients with GOLD 2-4 COPD: results from two 6-week crossover studies

Gregory J Feldman et al. Springerplus. .

Abstract

Abstract: These studies evaluated the 24-h forced expiratory volume in 1 sec (FEV1) profile of once-daily (QD) olodaterol compared to placebo and twice-daily (BID) formoterol in patients with moderate to very severe chronic obstructive pulmonary disease. In two replicate, randomized, double-blind, double-dummy, four-way crossover studies, patients received olodaterol 5 and 10 μg QD, formoterol 12 μg BID, or placebo for 6 weeks in addition to usual-care background maintenance therapy. Co-primary end points were FEV1 area under the curve from 0-12 h (AUC0-12) response (change from baseline) and FEV1 AUC from 12-24 h (AUC12-24) response after 6 weeks, with FEV1 AUC from 0-24 h response identified as a key secondary end point. Other secondary end points included FEV1 AUC from 0-3 h and trough FEV1 responses, as well as corresponding forced vital capacity responses. With both olodaterol doses, FEV1 increased to near-maximal 30 min post-morning dose, which was sustained over 24 h. FEV1 also increased within 30 min post-morning dose of formoterol and was sustained over 12 h; the second formoterol dose resulted in a further increase, sustained for an additional 12 h. FEV1 AUC0-12 and AUC12-24 responses with both QD olodaterol doses and BID formoterol were significantly greater than placebo at 6 weeks (P < .0001). Secondary end-point outcomes were consistent with those of the co-primary end points. These data, together with those from the wider phase III clinical program, provide evidence for the 24-h bronchodilator efficacy of olodaterol QD in this patient population.

Trial registry: ClinicalTrials.gov; NCT00931385 and NCT00932646.

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Figures

Figure 1
Figure 1
Study design. BID = twice daily; QD = once daily.
Figure 2
Figure 2
CONSORT diagram illustrating participant flow in (a) study 1222.24 and (b) study 1222.25. AE = adverse event. aAll patients who completed 4 treatment periods.
Figure 3
Figure 3
FEV 1 24-h profiles of olodaterol 5 and 10 μg and formoterol 12 μg BID compared to placebo at week 6 in (a) study 1222.24 and (b) study 1222.25. BID = twice daily; FEV1 = forced expiratory volume in 1 sec.
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