Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease

Abstract

Objective:

To evaluate the efficacy and safety of budesonide (BUD)/formoterol (FORM) compared with BUD, both administered by way of a dry powder inhaler (Turbuhaler^*).

* Turbuhaler is a registered trade name of AstraZeneca, Södertälje, Sweden.

Methods:

This was a 6-month, multicenter, randomized, parallel-group, double-blind, double-dummy design study (NCT 00421122). Patients were randomized to either BUD/FORM 160/4.5 μg, two inhalations twice daily, or BUD 200 μg, two inhalations twice daily. Improvement of lung function, daily symptoms, reliever use and health-related quality-of-life (St George’s Respiratory Questionnaire [SGRQ] score) were compared between the two treatment groups.

Results:

A total of 308 patients with moderate to very severe COPD from 12 centers in China were randomized to BUD/FORM (n = 156) or BUD (n = 152). The primary endpoint, 1-hour post-dose forced expiratory volume in 1 second (FEV₁), in the BUD/FORM group improved by 0.18 L (from 0.83 L at baseline to 1.01 L) and this was significantly better (p < 0.001) than the small increase (0.03 L) observed in the BUD group after 24 weeks’ treatment. Increases in pre-dose and 15-min post-dose FEV₁ together with 1-hour post-dose forced vital capacity were also significantly larger with BUD/FORM than BUD (p < 0.001 for all). Compared with BUD alone, BUD/FORM improved COPD total symptom scores (−1.04 ± 0.16 vs. −0.55 ± 0.17; p = 0.03), reduced reliever use (−0.85 ± 0.16 puffs/day vs. −0.31 ± 0.16 puffs/day; p = 0.012) and improved health-related quality-of-life (mean change of total SGRQ score −4.5 points (p = 0.0182). Overall, both treatments were well tolerated.

Conclusions:

In Chinese patients with moderate to very severe COPD, fixed combination treatment with BUD/FORM resulted in clinically meaningful improvements in lung function, health-related quality-of-life, COPD symptoms and a reduction in reliever use, compared with BUD alone and both treatments were well tolerated. Treatment of BUD/FORM for milder patients with COPD and head to head comparison of Chinese and Caucasians in future studies will be helpful to expand upon the findings of the current clinical trial.

Keywords::

• Budesonide/formoterol
• chronic obstructive pulmonary disease
• dry powder inhaler
• Lung function

Transparency

Declaration of funding

This study was sponsored by AstraZeneca. However, the authors conducted the clinical trial and prepared the various drafts of the manuscript independently.

Declaration of financial/other relationships

N.Z., J.Z., F.W., L.Y., P.C., Q.X., W.Y, T.S., Z.Z., H.S., Y.S., J.L. and Q.L. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewer 1 has disclosed that they have no relevant financial relationships; peer reviewer 2 has disclosed that he has served as a consultant for Novartis, Amgen, GSK, BI, Forest, and Pfizer.

Acknowledgments

English language editorial assistance was provided by Dr Steve Clissold, ContentEdNet and was supported by AstraZeneca. The authors would like to thank all investigators for their dedicated and important contributions to this study.

Notes

* Turbuhaler is a registered trade name of AstraZeneca, Södertälje, Sweden.

* Turbuhaler is a registered trade name of AstraZeneca, Södertälje, Sweden.