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Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma (MEXIC)

2019年6月24日 更新者：Novartis Pharmaceuticals

Multicentric, Open-label, Randomized, Parallel--group Study to Evaluate the Efficacy and Safety of Omalizumab in a 12- Month Period, in Patients With Severe IgE-mediated Asthma Inadequately Controlled With High Doses of Corticosteroids.

Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of corticosteroids.

研究概览

地位

终止

条件

干预/治疗

详细说明

This was a multicentric, open label, randomized, parallel-group study with a 12-month treatment period. Participants were assigned to one of the 2 treatment groups, omalizumab plus budesonide/formoterol or budesonide/formoterol alone.

The study comprised 4 phases:

During the 4-week run-in phase adult participants received budesonide 800 mg and formoterol 24 mg. If a participant complied with all inclusion and exclusion criteria and had received the according-to-age run-in proposed doses during the last month, the participant continued to the stable-steroid phase.

During the 16-week stable-steroid phase, adult and pediatric eligible participants were randomized to one of the two treatment groups.

During the 8-week steroid-reduction phase, adult and pediatric participants reduced 25% of the budesonide baseline dose every 2 weeks, depending of the asthma control, until they reached a 100% reduction of the baseline dose. The clinical control of asthma was defined according to criteria (GINA 2012).

研究类型

介入性

注册 (实际的)

112

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 墨西哥
    • Chiapas
      • Tuxtla Gutierrez、Chiapas、墨西哥、29030
        • Novartis Investigative Site
    • Distrito Federal
      • Mexico、Distrito Federal、墨西哥、14050
        • Novartis Investigative Site
      • Mexico、Distrito Federal、墨西哥、06760
        • Novartis Investigative Site
      • Mexico、Distrito Federal、墨西哥、03100
        • Novartis Investigative Site
      • Mexico、Distrito Federal、墨西哥、03020
        • Novartis Investigative Site
      • Mexico、Distrito Federal、墨西哥、06090
        • Novartis Investigative Site
      • Mexico、Distrito Federal、墨西哥、04700
        • Novartis Investigative Site
      • Mexico、Distrito Federal、墨西哥、04980
        • Novartis Investigative Site
      • Mexico City、Distrito Federal、墨西哥、14000
        • Novartis Investigative Site
    • Edo. De México
      • Mexico、Edo. De México、墨西哥、53910
        • Novartis Investigative Site
    • Estado De Mexico
      • Nezahualcoyotl、Estado De Mexico、墨西哥、57730
        • Novartis Investigative Site
    • Hidalgo
      • Pachuca de Soto、Hidalgo、墨西哥、42090
        • Novartis Investigative Site
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、44600
        • Novartis Investigative Site
      • Guadalajara、Jalisco、墨西哥、44500
        • Novartis Investigative Site
      • Guadalajara、Jalisco、墨西哥、44620
        • Novartis Investigative Site
      • Guadalajara、Jalisco、墨西哥、44690
        • Novartis Investigative Site
      • Guadaljara、Jalisco、墨西哥、44500
        • Novartis Investigative Site
    • Nayarit
      • Tepic、Nayarit、墨西哥、63000
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey、Nuevo León、墨西哥、64020
        • Novartis Investigative Site
      • Monterrey、Nuevo León、墨西哥、64718
        • Novartis Investigative Site
    • Yucatán
      • Mérida、Yucatán、墨西哥、97070
        • Novartis Investigative Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 55年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria

  • Male and female between 6 and 55 years old. If female, participant of childbearing potential must use a safe and efficacious birth control method.

  • Asthma is considered as not well-controlled if participant has 3 or more of the following conditions:

    1. Persistent day symptoms with current therapy twice at week or more, (siblings, dyspnea, cough, chest pain, thoracic oppression).
    2. One or more night-time awakenings over the last 4 weeks.
    3. Any limitation of age-appropriated habitual activities.
    4. Need of rescue medication (short acting β2 agonist) for two or more occasions per week during the last 4 weeks before screening and 2 consecutive weeks within the 4 weeks before selection.
    5. Peak expiratory flow (PEF) or VEF1 <80% predicted or personal best (if known) this is not mandatory for pediatric participants (under 18 years old).
  • Despite continuous treatment with high-dose inhaled corticosteroids (ICS) or oral corticosteroids (OCS) (CSO≥ 1 mg/kg/day) with or without controllers (As per GINA 2012 definition), the subject is receiving high doses of ICS (budesonide or its equivalent) and a long-acting β2-agonists(LABA) (formoterol) for the past 12 weeks at visit 0.
  • At last one documented asthma exacerbation (defined as increase asthma symptoms requiring systemic corticosteroid rescue therapy) that requires visits to the emergency room or to be hospitalized in the past 12 months. It is also considered asthma exacerbation a non-planned visit that required rescue medication (β2-agonists and/or steroid nebulization every 20 minutes or β2-agonists inhaler shots every 20 minutes).
  • Positive skin test or in vitro reactivity to a perennial aeroallergen, documented during the 12 months previous screening.
  • IgE total concentration ranging from 30 to 1500 UI/ml.
  • Body weight between 20 to 150 kg Exclusion Criteria
  • Pregnant or lactating female or without safe and efficacious birth control method if of childbearing potential.
  • Currently smokers or history of smoking 10 or more packs per year.
  • Ex-smokers with a history of more than 10 years of smoking. As an exception, a participant with this criterion will be considered as eligible if the FEV1 reversibility of the first spirometry reaches 12%.
  • Active lung disease other than asthma.
  • Use of methotrexate, gold salts, troleandomycin, cyclosporine, immunosuppressants, gammaglobulin or any other type of monoclonal antibody used during the 6 months prior to the initial visit.
  • Use of omalizumab during the 4 months prior to de screening visit.
  • History of renal disease, cardiovascular disease, metabolic disease, hematologic disease, gastrointestinal disease, as well as immunodeficiency or cerebrovascular disease currently under treatment but not-controlled.
  • History of hepatic, neurologic, oncologic or autoimmune disease.
  • Participant under suspicion of having cancer.
  • Participants with history of hypersensitivity to sucrose, histidine, polysorbate 20 as well as to monoclonal antibodies or gammaglobulin.
  • Hypersensitivity to omalizumab or its excipients.
  • Abnormal values of the blood chemistry laboratory tests, over 2 times the upper limit normal, that are considered clinically significant.
  • Underage participant or any participant under vulnerable conditions who does not live with their parents or legal guardian.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Omalizumab + budesonide and formoterol
Participants will receive Omalizumab every 2 or 4 weeks depending on IgE level and body weight and will also receive budesonide and formoterol according to maximum daily dose.
药品：Omalizumab
Subcutaneous injection dose according to the IgE level and body weight.
药品：Budesonide
Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.
药品：Formoterol
Formoterol 12ug tablets taken orally according to maximum daily dose.
药品：Budesonide
Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
药品：Formoterol
Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
有源比较器：Budesonide and formoterol
Participants will receive budesonide and formoterol according to maximum daily dose.
药品：Budesonide
Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.
药品：Formoterol
Formoterol 12ug tablets taken orally according to maximum daily dose.
药品：Budesonide
Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
药品：Formoterol
Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
The Mean Prescribed Budesonide Dose (μg) at Baseline
大体时间：Baseline
prescribed budesonide dose (in μg) at Baseline in intention to treat population and in intention to treat population
Baseline

次要结果测量

结果测量
措施说明
大体时间
Number of Hospital Admissions Due to Asthma Exacerbation
大体时间：12 month treatment duration
A hospital admission is defined as admissions to hospital involving a stay of at least 24 hours.
12 month treatment duration
Days Missed in School/Work Due to Asthma Exacerbation Episodes
大体时间：12 month treatment duration
Participants /parent/legal guarding reported number of missed days of school or work at each study visit via diaries.
12 month treatment duration
Control of Asthma Symptoms- Daytime Symptoms
大体时间：12 month treatment duration
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
12 month treatment duration
Control of Asthma Symptoms
大体时间：12 month treatment duration
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
12 month treatment duration
Control of Asthma Symptoms- Rescue Medication Use
大体时间：12 month treatment duration
The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal
12 month treatment duration
Participants Requiring Oral Systemic Corticosteroids During the 12 Month Study Duration
大体时间：12 month treatment duration
Number of days of concomitant medications use reported by participants at all visits via diaries.
12 month treatment duration
Asthma Control Questionnaire (ACQ) at Baseline
大体时间：Baseline
The Asthma Control Questionnaire (ACQ) has six questions to be answered by the participants, each with a 7 point scale (0-good control, 6-poor control), and one question where the actual pre-bronchodilator Forced expiratory volume in 1 second (FEV1) value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma.
Baseline
Asthma Quality of Life Questionnaire (AQLQ) at Baseline
大体时间：Baseline
The quality of life will be measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score for adults and the pediatric version of the AQLQ(S) for pediatric participants (PAQLQ[S]) . The AQLQ(S) and PAQLQ(S0 contain 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; each item is measured in a 7-point Likert scale of 1 to 7 (1 = severe impairment, 7 = no impairment). All items are weighted equally. Mean score is calculated across all items within each domain and the overall score is the mean score of the 32 items.
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年11月11日

初级完成 (实际的)

2015年8月6日

研究完成 (实际的)

2016年1月8日

研究注册日期

首次提交

2013年7月29日

首先提交符合 QC 标准的

2013年7月30日

首次发布 (估计)

2013年7月31日

研究记录更新

最后更新发布 (实际的)

2019年7月2日

上次提交的符合 QC 标准的更新

2019年6月24日

最后验证

2019年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CIGE025AMX02

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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