Tiotropium as an add‑on treatment to inhaled corticosteroids in children with severe and mild symptomatic asthma: Multi‑center observational study for efficacy and safety analysis

Aierken,Aibibai; Yu Su Fu,Bu Wei Mai Erye Mu; Xu,Peiru

doi:10.3892/etm.2022.11514

Tiotropium as an add‑on treatment to inhaled corticosteroids in children with severe and mild symptomatic asthma: Multi‑center observational study for efficacy and safety analysis

Authors:
- Aibibai Aierken
- Bu Wei Mai Erye Mu Yu Su Fu
- Peiru Xu
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Affiliations: Department of Pediatrics, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region 830054, P.R. China, Department of Pediatrics, The First People's Hospital of Kashi, Kashi, Xinjiang Uygur Autonomous Region 844000, P.R. China, Department of Pediatrics, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region 830054, P.R. China
Published online on: July 19, 2022 https://doi.org/10.3892/etm.2022.11514
Article Number: 577

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Abstract

Children aged 6‑11 years with uncontrolled asthma are treated with low‑dose inhaled corticosteroid (ICS) with stepwise increase in ICS dosage and/or add‑on maintenance treatment, as necessary. The objective of the present study was to evaluate the efficacy and safety of tiotropium add‑on treatment in children with severe and mild symptomatic asthma. The present prospective cohort study included 144 children with severe and mild asthma (age, 6‑11 years) who received ICS (budesonide) with ≥1 controller treatment combination therapies for ≥1 month and score ≥1.5 based on Asthma Control Questionnaire‑Interviewer‑Administered. In addition to ICS with ≥1 controller treatment, children received 5 µg once‑daily tiotropium (treatment group; n=72) or did not receive tiotropium (control group; n=72). The peak forced expiratory volume in 1‑sec change from the baseline 3 h post‑administration of tiotropium was significantly improved in the treatment group compared with the control group (384±31 vs. 248±28 ml; P<0.0001). The trough forced expiratory volume in 1‑sec (224±28 vs. 140±31 ml; P<0.0001) and forced expiratory flow at 25‑75% of forced vital capacity (389±36 vs. 116±27 ml/sec; P<0.0001) showed significant improvement following treatment with tiotropium. Significant differences were noted for trough forced vital capacity (153±29 vs. 139±30 ml/sec; P<0.0001), mean weekly rescue treatment usage (0.29±0.08 vs. 0.36±0.09; P<0.0001), mean weekly peak expiratory flow measurement (4.12±3.56 vs. 7.46±3.29 l/min; P<0.0001) and mean weekly symptom‑free time (0.19±0.04 vs. 0.16±0.04 days; P<0.0001) between both cohorts. Children of both groups tolerated any adverse effects. Tiotropium 5 µg administered once/day as an add‑on treatment to ICS with ≥1 controller treatments in children (6‑11 years of age) with severe and mild symptomatic asthma was found to be efficacious and safe (level of evidence 2; technical efficacy stage 4).

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