본문 바로가기
HOME> 논문 > 논문 검색상세

논문 상세정보

The Lancet. Respiratory medicine v.6 no.2, 2018년, pp.127 - 137   SCIE
본 등재정보는 저널의 등재정보를 참고하여 보여주는 베타서비스로 정확한 논문의 등재여부는 등재기관에 확인하시기 바랍니다.

Safety and efficacy of tiotropium in children aged 1–5 years with persistent asthmatic symptoms: a randomised, double-blind, placebo-controlled trial

Vrijlandt, Elianne J L E (Department of Pediatric Pulmonology and Pediatric Allergy, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, Groningen, Netherlands ) ; El Azzi, Georges (TA Respiratory Diseases, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany ) ; Vandewalker, Mark (Clinical Research of the Ozarks, Columbia, MO, USA ) ; Rupp, Ned (National Allergy and Asthma Research, North Charleston, SC, USA ) ; Harper, Thomas (Charleston Allergy and Asthma, Charleston, SC, USA ) ; Graham, LeRoy (Children's Healthcare of Atlanta, Atlanta, GA, USA ) ; Szefler, Stanley J (Department of Pediatrics Breathing Institute and Pediatric Pulmonary Section, Children's Hospital of Colorado and the University of Colorado School of Medicine, Aurora, CO, USA ) ; Moroni-Zentgraf, Petra (Boehringer Ingelheim, Sydney, Australia ) ; Sharma, Ashish (Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA ) ; Vulcu, Sebastian D (Global Pharmacovigilance, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany ) ; Sigmund, Ralf (Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany ) ; Chawes, Bo (Copenhagen Pros ) ; Engel, Michael ; Bisgaard, Hans ;
  • 초록  

    Summary Background Few studies have assessed the safety and efficacy of potential asthma medications in children younger than 5 years. We descriptively assessed the safety and efficacy of tiotropium, a long-acting anticholinergic drug, in children aged 1–5 years with persistent asthmatic symptoms. Methods This exploratory 12-week, randomised, double-blind, placebo-controlled, parallel-group, phase 2/3, regulatory multicentre trial was done at 32 hospitals, clinics, and clinical research units in 11 countries in Asia, Europe, and North America. Children aged 1–5 years with at least a 6-month history of persistent asthmatic symptoms and a need for inhaled corticosteroids were eligible. Patients were randomly allocated using an interactive voice or web-based response system to receive once-daily tiotropium 2·5 μg, tiotropium 5 μg, or placebo as an add-on to inhaled corticosteroids with or without additional controller medication. Patients and investigators were masked to study group assignment. Tiotropium was given via the Respimat inhaler once daily as two puffs of 1·25 μg in the 2·5 μg group, two puffs of 2·5 μg in the 5 μg group, or two puffs of placebo. The primary outcomes were safety, which was assessed by comparing adverse events between the tiotropium and placebo groups, and efficacy, which was measured as the change in weekly mean combined daytime asthma symptom score from baseline to week 12. Statistical analyses of treatment effects were exploratory; although endpoints were defined, they were used for descriptive analyses only. The safety and primary analyses were done in all patients who received at least one dose of their assigned treatment. This study is registered with ClinicalTrials.gov (NCT01634113), and is completed. Findings Between July 26, 2012, and Dec 4, 2014, 102 children were randomly assigned to the three treatment groups (36 to receive tiotropium 2·5 μg, 32 to receive tiotropium 5 μg, and 34 to receive placebo). 101 children completed the study and were included in the analyses. The changes in adjusted weekly mean combined daytime asthma symptom scores between baseline and week 12 were not significantly different between any of the groups. The adjusted mean difference between the tiotropium 2·5 μg group and placebo group was −0·080 (95% CI −0·312 to 0·152) and the difference between tiotropium 5 μg and placebo group was −0·048 (−0·292 to 0·195). Adverse events were less frequent with tiotropium treatment than with placebo (20 [56%] of 36 children with tiotropium 2·5 μg, 18 [58%] of 31 with tiotropium 5 μg, and 25 [74%] of 34 with placebo), although no formal statistical comparison between groups was performed. A greater proportion of children reported asthma exacerbations as adverse events in the placebo group (ten [29%] of 34) than in the tiotropium groups (five [14%] of 36 in the 2·5 μg group and two [6%] of 31 in the 5 μg group). Serious adverse events were reported in three patients (all of whom received placebo); no adverse events led to discontinuation of treatment or death. Interpretation To our knowledge, our small study is the first to assess the safety and efficacy of tiotropium in children aged 1–5 years with persistent asthmatic symptoms. Tolerability of tiotropium was similar to that of placebo, which is consistent with previous findings in older populations. Although mean daytime asthma symptom scores were not significantly different between groups, tiotropium showed the potential to reduce asthma exacerbation risk compared with placebo. The findings of the study are limited by the small sample size and descriptive statistical analyses. Additional well powered trials are needed to further assess the safety and e


 활용도 분석

  • 상세보기

    amChart 영역
  • 원문보기

    amChart 영역

원문보기

무료다운로드
  • 원문이 없습니다.

유료 다운로드의 경우 해당 사이트의 정책에 따라 신규 회원가입, 로그인, 유료 구매 등이 필요할 수 있습니다. 해당 사이트에서 발생하는 귀하의 모든 정보활동은 NDSL의 서비스 정책과 무관합니다.

원문복사신청을 하시면, 일부 해외 인쇄학술지의 경우 외국학술지지원센터(FRIC)에서
무료 원문복사 서비스를 제공합니다.

NDSL에서는 해당 원문을 복사서비스하고 있습니다. 위의 원문복사신청 또는 장바구니 담기를 통하여 원문복사서비스 이용이 가능합니다.

이 논문과 함께 출판된 논문 + 더보기