Clinical benefit of two-times-per-day aclidinium bromide compared with once-a-day tiotropium bromide hydrate in COPD: a multicentre, open-label, randomised study

Abstract

Objective

Chronic obstructive pulmonary disease (COPD) is mainly treated pharmaceutically with bronchodilators. The purpose of this study was to evaluate the clinical benefits of two-times-per-day aclidinium bromide (Acli-BID) compared with once-a-day tiotropium bromide hydrate (Tio-QD) in patients with COPD.

Design

This study was a multicentre, open-label, randomised study.

Setting

Fourcentres in Kagawa prefecture, Japan.

Participant

Patients who were diagnosed to have COPD Grade 2–3 according to the Global Initiative for Chronic Obstructive Lung Disease 2015 criteria were enrolled.

Interventions

Patients were randomly assigned to receive Acli-BID or Tio-QD at a 1:1 ratio, and followed for 8 weeks. Acli-BID was administered in the morning and night, and Tio-QD was administered in the night.

Primary and secondary outcome measures

Primary outcome was forced expiratory volume in one second area under the curve (FEV ₁AUC _0-3), and secondary outcomes were pulmonary function, physical activity, St George’s Respiratory Questionnaire (SGRQ), modified Medical Research Council (mMRC), the 8-item Short-Form Health Survey (SF-8) and COPD exacerbations. Adverse events were evaluated during the study.

Results

44 patients were included in this study. FEV ₁AUC _0-3 at week 8 was 4.62±1.43 L·hour in Acli-BID and 4.73±1.60 L·hour in Tio-QD (mean difference (MD) −0.11 L·hour; 95% CI), −1.04 to 0.83). Significant improvement was observed in activity-related subscales of SGRQ (MD −7.78; 95% CI −14.61 to −0.94) and SF-8 (MD 4.01; 95% CI 0.37 to 7.65), mMRC (MD −0.66; 95% CI −1.19 to −0.13) and rate ratio (0.52, 95% CI 0.27 to 0.99) of exacerbations in the Acli-BID compared with the Tio-QD. Acli-BID and Tio-QD significantly improved sedentary behaviour (MD −35.20 min; 95% CI −67.41 to −2.94 and MD −55.40 min; 95% CI −98.15 to −12.77) within each group, but there was no significant difference between the two groups.

Conclusion

Acli-BID as with Tio-QD could be one of the therapeutic options for patients with COPD to improve pulmonary function. Also, our results suggest that intervention with bronchodilators enhanced physical activity in patients with COPD.

Trial registration number

UMIN 000020020.