ISRCTN12109108进行中（未招募）未知
Treating severe paediatric asthma: a randomised controlled trial of mepolizumab and omalizumab (TREAT trial)
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39174059/ (added 23/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 02/02/2023:
- •1. Written informed consent given
- •2. Aged 6 to 16 years
- •3. Confirmed diagnosis of asthma
- •4. Poor asthma control despite being prescribed high dose therapy
- •Inclusion criteria for RCT phase:
- •1. Written informed consent
- •2. Children aged 6-17 years
- •3. Confirmed diagnosis of asthma with one of the following:
- •3.1. Persistent poor control =1 attack after adherence assessment with =80% adherence during run-in (STRA) 3.2. Persistent poor control and poor adherence despite optimal efforts to improve adherence, including enhanced monitoring (Refractory DA)
- •4. Female patients capable of becoming pregnant must agree to use hormonal contraception, intrauterine device, intrauterine hormone-releasing system, or to complete abstinence for the duration of the trial and up to 100 days after the last dose of IMP
- •Previous participant inclusion criteria as of 10/09/2020:
- •Inclusion criteria for run-in phase:
- •1. Written informed consent given
- •2. Aged 6 to 16 years
- •3. Patients capable of becoming pregnant must agree to use hormonal contraception, intrauterine device, intrauterine hormone-releasing system, or to complete abstinence for the duration of the trial and up to 100 days after the last dose of IMP
- •4. Confirmed diagnosis of asthma
- •5. Poor asthma control despite being prescribed high dose therapy
- •Inclusion criteria for RCT phase:
- •1. Children aged 6-17 years
- •2. Confirmed diagnosis of asthma with one of the following:
- •2.1. Persistent poor control =1 attack after adherence assessment with =80% adherence during run-in (STRA) 2.2. Persistent poor control and poor adherence despite optimal efforts to improve adherence, including enhanced monitoring (Refractory DA)
- •Previous participant inclusion criteria:
- •1. Confirmed diagnosis of asthma
- •2. On high dose maintenance treatment (>/=800mcg per day budesonide/equivalent and long-acting beta agonist)
- •3. At least 4 severe attacks (defined as the need for a short course of oral steroids, or hospitalisation) in the previous 12 months, OR if on maintenance oral steroids then at least 2 severe attacks in the last 12 months
- •4. Poor asthma control defined as a score of < 20 on the Asthma Control Test (ACT) [children aged 12-16 years], or childhood Asthma Control Test (cACT) [children aged 6-11 years]
排除标准
- •Current participant exclusion criteria as of 10/09/2020:
- •1. Considered unfit for the study or risk of noncompliance with study procedures by the responsible physician as a result of medical interview, physical examination or screening investigation
- •2. Known hypersensitivity to Omalizumab or Mepolizumab or to any of the excipients
- •3. History of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation
- •4. Pregnant, lactating or within 6 weeks post-partum or breast feeding
- •5. Participated within 3 months in a study using a new molecular entity, another study investigating drugs or in a study with invasive procedures
- •6. Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the main diagnosis; they can be present in addition to asthma major problem rather than in addition to severe asthma)
- •7. Significant other primary pulmonary disorders in particular cystic fibrosis, or interstitial lung disease
- •8. Diagnosis of chronic inflammatory diseases other than asthma (e.g. inflammatory bowel disease)
- •Previous participant exclusion criteria:
- •1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study or has a risk of non-compliance with study procedures
- •2. The child has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation
- •3. Participant is female who is pregnant, lactating or within 6 weeks post-partum or breastfeeding
- •4. The child has participated within 3 months in a study using a new molecular entity, another study investigating drugs or in a study with invasive procedures
- •5. Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma)
- •6. Significant other primary pulmonary disorders in particular cystic fibrosis, or interstitial lung disease
- •7. Diagnosis of chronic inflammatory diseases other than asthma (e.g. inflammatory bowel disease)
研究者
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