小児喘息発作を半減させる吸入薬療法を実証(Combination inhaler reduces asthma attacks in children by almost half)

2025-09-30

2025-09-28 インペリアル・カレッジ・ロンドン(ICL)

国際共同研究チームは、5〜15歳の子ども360人を対象に、2種類の吸入薬を比較する大規模臨床試験(CARE試験)を実施した。その結果、抗炎症薬ブデソニドと速効性気管支拡張薬ホルモテロールを組み合わせた「2-in-1吸入器」を必要時に使用することで、従来のサルブタモール吸入器と比べて喘息発作が平均45%減少することが明らかになった。安全性にも問題はなく、成長や肺機能、全般的な喘息管理に差は認められなかった。この成果は、成人ではすでに推奨されている治療を小児にも適用できる強力な証拠であり、世界1億1,300万人以上の小児喘息患者に恩恵をもたらす可能性がある。研究者らは、今回の結果が国際的な喘息治療ガイドラインを子どもにも適用する契機になると強調している。

<関連情報>

軽症喘息児における緩和療法としてのブデソニド・ホルモテロールとサルブタモールの比較(CARE):52週間、非盲検、多施設、優越性、ランダム化比較試験 Budesonide–formoterol versus salbutamol as reliever therapy in children with mild asthma (CARE): a 52-week, open-label, multicentre, superiority, randomised controlled trial

Lee Hatter, MD ∙ Mark Holliday, BSc ∙ Karen Oldfield, PhD ∙ Ciléin Kearns, MD ∙ Tasmin Barry, MBChB ∙ Melissa Black, MSc ∙ et al.
The Lancet Published: September 27, 2025
DOI:https://doi.org/10.1016/S0140-6736(25)00861-X

Summary

Background

Combination inhaled corticosteroid–formoterol reliever monotherapy reduces the rate of asthma attacks compared to short-acting β₂-agonist (SABA) reliever monotherapy in adults. Its comparative efficacy in children has not been established.

Methods

CARE was a 52-week, open-label, parallel-group, multicentre, superiority, randomised controlled trial in children aged 5–15 years with asthma using SABA reliever monotherapy at 15 clinical trials sites in New Zealand. Participants were randomly assigned (1:1) to either budesonide 50 μg–formoterol 3 μg, two actuations as needed, or salbutamol 100 μg, two actuations as needed. The primary outcome was asthma attacks as rate per participant per year. This trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN12620001091998.

Findings

From Jan 28, 2021, to June 23, 2023, we assessed 382 participants for eligibility. We randomly assigned 360 (94%) participants to treatment (179 [50%] to the budesonide–formoterol group and 181 [50%] to the salbutamol group). The annualised rate of asthma attacks was lower in the budesonide–formoterol group than in the salbutamol group—cluster-adjusted rates 0·23 versus 0·41 per participant per year (relative rate 0·55 [95% CI 0·35–0·86]; p=0·012). The number of participants with at least one adverse event was 162 (91%) in the budesonide–formoterol group and 167 (92%) in the salbutamol group (odds ratio 0·79 [95% CI 0·35–1·79]).

Interpretation

In children aged 5–15 years with mild asthma, budesonide–formoterol reliever monotherapy is superior to salbutamol for preventing asthma attacks, with a similar safety profile.