Respiratory health outcomes and treatment of patients with mild-to-moderate COPD not eligible for previous major randomized controlled trials

Fan Wu; Zhishan Deng; Qi Wan; Kuning Zhou; Youlan Zheng; Suyin Huang; Heshen Tian; Jieqi Peng; Zihui Wang; Cuiqiong Dai; Lifei Lu; Xiaohui Wu; Gaoying Tang; Xianliang Zeng; Binwei Hao; Haiqing Li; Nanshan Zhong; Yumin Zhou; Pixin Ran; on behalf of the Tie-COPD study and the ECOPD study investigators

doi:10.59717/j.xinn-med.2025.100161

The Innovation Medicine > 2025 Vol. 3 > No. 4 > 100161

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Respiratory health outcomes and treatment of patients with mild-to-moderate COPD not eligible for previous major randomized controlled trials

Fan Wu^1,2,5,
Zhishan Deng^1,5,
Qi Wan¹,
Kuning Zhou¹,
Youlan Zheng^1,2,
Suyin Huang^1,2,
Heshen Tian³,
Jieqi Peng^1,2,
Zihui Wang¹,
Cuiqiong Dai¹,
Lifei Lu¹,
Xiaohui Wu^1,2,
Gaoying Tang¹,
Xianliang Zeng¹,
Binwei Hao⁴,
Haiqing Li¹,
Nanshan Zhong^1,2,
Yumin Zhou^1,2, ,,
Pixin Ran^1,2, ,,
on behalf of the Tie-COPD study and the ECOPD study investigators

1.
State Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease & National Center for Respiratory Medicine & Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China
2.
Guangzhou National Laboratory, Guangzhou 510250, China
3.
Key Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou 310009, China
4.
Department of Pulmonary and Critical Care Medicine, Shanxi Bethune Hospital Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan 037036, China
5.
These authors contributed equally

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Corresponding authors: zhouyumin410@126.com (Y.Z.); pxran@gzhmu.edu.cn (P.R.)
Received Date: May 16, 2025

Accepted Date: September 29, 2025

Published Online: September 30, 2025

The Innovation Medicine 3(4), https://doi.org/10.59717/j.xinn-med.2025.100161 | Cite this article

GRAPHICAL ABSTRACT

GRAPHICAL ABSTRACT

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PUBLIC SUMMARY

PUBLIC SUMMARY
1. Mild-to-moderate COPD not eligible for major trials have faster annual lung function decline than normal spirometry.
  
  Tiotropium improved respiratory outcomes in patients with mild-to-moderate COPD not eligible for major trials.
  
  Patients with mild-to-moderate COPD not eligible for previous major trials needs treatment and treatment is effective.

ABSTRACT

ABSTRACT

Many real-world patients with chronic obstructive pulmonary disease (COPD) are not eligible for previous major randomized clinical trials of COPD. Therefore, we aimed to explore the respiratory health outcomes and effectiveness of treatment among patients with mild-to-moderate COPD not eligible for previous major trials. In a cohort study, we explored the clinical characteristics and lung function decline of patients with mild-to-moderate COPD not eligible for previous major trials. In a post hoc analysis of multicenter clinical trial, we evaluated the effectiveness of tiotropium in patients with mild-to-moderate COPD not eligible for previous major trials. Patients not eligible for previous major trials were never-smokers; had a smoking index of <10 pack-years; or had a post-bronchodilator FEV₁ of ≥80% predicted, or asthma. Overall, 475 patients with mild-to-moderate COPD not eligible for major trials and 398 symptomatic participants with normal spirometry were included. Patients not eligible for major trials have more severe small airway dysfunction, emphysema, and faster annual lung function decline than symptomatic participants with normal spirometry. From the multicenter clinical trial, 428 patients with mild-to-moderate COPD not eligible for major trials were included. Tiotropium significantly increased pre-bronchodilator FEV₁ than placebo at 24 months (difference=128 [95% CI: 78–177] mL, P<0.001), reduced acute exacerbations (RR=0.55 [95% CI: 0.40–0.77], P<0.001), and ameliorated the annual decline in post-bronchodilator FEV₁ in patients not eligible for previous major trials. Mild-to-moderate COPD patients not eligible for major trials had poor respiratory health outcomes than symptomatic participants with normal spirometry and long-term treatment with tiotropium can improve their respiratory health outcomes.

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Wu F., Deng Z., Wan Q., et al. (2025). Respiratory health outcomes and treatment of patients with mild-to-moderate COPD not eligible for previous major randomized controlled trials. The Innovation Medicine 3:100161. https://doi.org/10.59717/j.xinn-med.2025.100161

Wu F., Deng Z., Wan Q., et al. (2025). Respiratory health outcomes and treatment of patients with mild-to-moderate COPD not eligible for previous major randomized controlled trials. The Innovation Medicine 3:100161. https://doi.org/10.59717/j.xinn-med.2025.100161

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Respiratory health outcomes and treatment of patients with mild-to-moderate COPD not eligible for previous major randomized controlled trials

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Respiratory health outcomes and treatment of patients with mild-to-moderate COPD not eligible for previous major randomized controlled trials

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