• Curr Med Res Opin · Feb 2012

    Randomized Controlled Trial Multicenter Study

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

    • Nanshan Zhong, Jinping Zheng, Fuqiang Wen, Lan Yang, Ping Chen, Qingyu Xiu, Wanzhen Yao, Tieying Sun, Ziwen Zhao, Huahao Shen, Yi Shi, Jiangtao Lin, and Qiang Li.
    • State Key Lab of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical College, Guangzhou, China.
    • Curr Med Res Opin. 2012 Feb 1; 28 (2): 257-65.

    ObjectiveTo 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.MethodsThis 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.ResultsA 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 FEV(1) 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.ConclusionsIn 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.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…

What will the 'Medical Journal of You' look like?

Start your free 21 day trial now.

We guarantee your privacy. Your email address will not be shared.