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Background <p>Chronic obstructive pulmonary disease (COPD) is a significant public health concern, and inhalation therapy is a critical component of its management. However, using an inhaler is challenging, especially for patients with COPD, who are often elderly and experience reduced dexterity, visual and cognitive impairment, and difficulty synchronizing inhalation with dose actuation. Synchrobreathe<sup>®</sup> is an easy-to-use, breath-actuated inhaler that releases medication during inhalation, addressing these challenges. Although its use in asthma is well documented, evidence in COPD is limited.</p> Methods <p>This prospective, multicenter, observational study carried out during August 2021 and August 2022 evaluated the clinical outcomes of the budesonide/formoterol combination (BUD/FORM) delivered through Synchrobreathe<sup>®</sup> in patients with COPD in India. The primary endpoint was disease control, that is, change from baseline in COPD Assessment Test (CAT) score at 12 weeks. Secondary endpoints included changes in CAT and modified Borg Dyspnea Scale (mBDS) scores and device usability. Adverse events were monitored over 12 weeks.</p> Results <p>In the study population (<i>N</i>&#xa0;=&#xa0;250), significant reductions from baseline were observed in mean CAT (−6.56&#xa0;±&#xa0;0.33; <i>p</i>&#xa0;&lt;&#xa0;0.001) and mBDS (−1.60&#xa0;±&#xa0;0.09; <i>p</i>&#xa0;&lt;&#xa0;0.0001) scores at 12 weeks. Almost all (98%) patients were satisfied with Synchrobreathe<sup>®</sup> and preferred it over their previous inhalers. No significant adverse events were reported.</p> Conclusion <p>BUD/FORM delivered through Synchrobreathe<sup>®</sup> significantly improved CAT and mBDS scores, with no reported serious adverse events in patients with COPD. Its simple usage makes it an effective option for this patient population.</p>

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Outcomes and Usability of Formoterol-Budesonide Delivered Through Synchrobreathe® in Patients With Chronic Obstructive Pulmonary Disease: The EMERGE Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月28日

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  • Santhalingam Balamurugan,
  • Himanshu Pophale,
  • Utsav Samariya,
  • Komalkirti Apte,
  • Sheetu Singh,
  • Raja Dhar,
  • Sujeet Rajan,
  • Rajesh Swarnakar,
  • Deepak Talwar,
  • Meena Lopez,
  • Vaishali Naik,
  • Sandesh Sawant,
  • Sushmeeta Chhowala,
  • Abhijit Vaidya,
  • Jaideep Gogtay

摘要

Background

Chronic obstructive pulmonary disease (COPD) is a significant public health concern, and inhalation therapy is a critical component of its management. However, using an inhaler is challenging, especially for patients with COPD, who are often elderly and experience reduced dexterity, visual and cognitive impairment, and difficulty synchronizing inhalation with dose actuation. Synchrobreathe® is an easy-to-use, breath-actuated inhaler that releases medication during inhalation, addressing these challenges. Although its use in asthma is well documented, evidence in COPD is limited.

Methods

This prospective, multicenter, observational study carried out during August 2021 and August 2022 evaluated the clinical outcomes of the budesonide/formoterol combination (BUD/FORM) delivered through Synchrobreathe® in patients with COPD in India. The primary endpoint was disease control, that is, change from baseline in COPD Assessment Test (CAT) score at 12 weeks. Secondary endpoints included changes in CAT and modified Borg Dyspnea Scale (mBDS) scores and device usability. Adverse events were monitored over 12 weeks.

Results

In the study population (N = 250), significant reductions from baseline were observed in mean CAT (−6.56 ± 0.33; p < 0.001) and mBDS (−1.60 ± 0.09; p < 0.0001) scores at 12 weeks. Almost all (98%) patients were satisfied with Synchrobreathe® and preferred it over their previous inhalers. No significant adverse events were reported.

Conclusion

BUD/FORM delivered through Synchrobreathe® significantly improved CAT and mBDS scores, with no reported serious adverse events in patients with COPD. Its simple usage makes it an effective option for this patient population.