Add-on Tiotropium in Chinese Patients With Moderate Asthma: A Pooled Subgroup Analysis of MezzoTinA-Asthma 1 and 2

Abstract

Purpose Asthma affects approximately 30 million patients in China; however, tiotropium data for Chinese patients is limited. This study aimed to assess the efficacy and safety of tiotropium in Chinese patients with moderate symptomatic asthma. Methods A post hoc subgroup analysis was conducted on 430 Chinese patients pooled from two 24-week, replicate phase 3 trials ( NCT01172808 and NCT01172821 ), in which they received once-daily tiotropium 2.5 µg (Tio R2.5) or 5 µg (Tio R5) (n = 106 or 109, respectively), twice-daily salmeterol 50 µg (Sal 50) (n = 110), or placebo (n = 105), while maintaining inhaled corticosteroids (ICS). The co-primary endpoints assessed in week 24 were forced expiratory volume in 1 second (FEV1) peak 0–3h response, trough FEV1 response, and responder rate as assessed using the Asthma Control Questionnaire (ACQ). Results For both FEV1 peak 0–3h responses and trough FEV1 responses, the mean treatment differences were greater for Tio R2.5, Tio R5, and Sal 50 compared with placebo at 0.249 L, 0.234 L, and 0.284 L, and 0.172 L, 0.180 L, and 0.164 L, respectively ( P < 0.001). The ACQ responder rate in placebo, Tio R2.5, Tio R5, and Sal 50 was 58.7%, 62.3%, 59.3%, and 69.1%, respectively. Furthermore, 11 (2.6%) of 430 patients had serious adverse events (Tio R5, n = 4; Tio R2.5, n = 1; Sal 50, n = 1; and placebo, n = 5). Conclusions Once-daily tiotropium, as add-on to medium-dose ICS, was effective and well tolerated for Chinese patients with moderate symptomatic asthma, consistent with the main analysis.

Longitudinal Model‐Based Meta‐Analysis of Lung Function Response to Support Phase III Study Design in Chinese Patients With Asthma

“…The modeling result showed race was not a significant covariate on G or T, indicating no potential significant difference in FEV1 trajectory, or treatment effect between patients in China and the rest of the world. Although there is no data in umeclidinium‐containing treatments from Chinese patients with asthma, literature data indicate that the effect of tiotropium, a LAMA with the same mechanism as umeclidinium, in Chinese patients with asthma is consistent with that in the rest of the world 15 . It is thus considered reasonable to assume that after accounting for other covariate effects, race would not impact the effect of fluticasone furoate/umeclidinium/vilanterol.…”

Challenges faced in managing adult asthma: A perspective from Asian countries

“…Tiotropium is now licenced for once daily maintenance use in asthma. Evidence from Asian countries such as Japan, 47 China 48,49 and South Korea 50 supports the safe use of tiotropium as an add-on option in severe asthmatic patients, especially for patients with recurrent exacerbations already on ICS + LABA.…”

เปรียบเทียบประสิทธิภาพระหว่างการใช้ยาไทโอโทรเปียมชนิดแฮนด์ดิเฮเลอร์(tiotropium handihaler) และการเพิ่มขนาดของยาพ่นสเตอรอยด์ (ICS)ในผู้ป่วยโรคหืดที่ยังคุมอาการไม่ได้ที่ใช้ยาพ่นสเตอรอยด์และยาขยายหลอดลมกระตุ้นเบต้ารีเซ็ปเตอร์ชนิดออกฤทธิ์นานขนาดปานกลางหรือขนาดสูง(moderate or high dose ICS/LABA) อยู่เดิม

“…กั บยาพ่ นสเตอรอยด์ (9) โดยแบ่ งการศึ กษาเป็ น 4 กลุ ่ ม โดยให้ ทุ กกลุ ่ มได้ ยาพ่ นสเตอรอยด์ ขนาด ปานกลาง แล้ ว randomization 1:1:1:…”