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Measuring Omalizumab Responses Using Real-world Evidence (MORRE) Study (MORRE)

2021年6月21日 更新者：National Jewish Health

Develop new real-world evidence indicators of worsening and improving asthma. Scientists will measure (1) steps per day, (2) duration and intensity of exercise per day, (3) sleep duration and the number of awakenings per night using Fitbit activity trackers. Scientists will measure asthma symptoms using a once-monthly custom survey delivered to participant smartphones via Twilio. Scientists may measure rescue medication use and adherence to maintenance medications using digital inhaler devices. Scientists will correlate the above measures to participant-reported significant asthma exacerbations (SAEs), lung function (FEV1), and standardized surveys (i.e. the asthma control test (ACT) and global evaluation of treatment effectiveness (GETE)(4)) collected in clinic every 3 months. Coordinators will record any medication changes or reported medication side effects.

Determine response to omalizumab therapy. After participants are placed on omalizumab therapy as part of standard medical care, scientists will determine whether and how real-world evidence can be used to gauge responses to omalizumab. Then, scientists will determine which features, or combination of features, are the best indicators of disease control in the real world.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (预期的)

50

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。

学习联系方式

学习地点

  • 美国
    • Colorado
      • Denver、Colorado、美国、80206
        • 招聘中
        • National Jewish Health
        • 接触：
          • Eileen Wang, MD, MPH

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

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Participants 18-85 years of age with moderate-to-severe asthma at the time of enrollment and eligible for omalizumab therapy.

描述

Inclusion Criteria:

  • A diagnosis of uncontrolled or difficult-to-treat asthma, defined as 1 course of systemic corticosteroids (e.g. oral prednisone) in the last 12 months OR an asthma control test (ACT) score less than or equal to 19 despite regular use of inhaled corticosteroids (ICS) therapy (at least 176 mcg of fluticasone/day or the equivalent) for at least 1 month prior to enrollment.
  • Participants will need access to a smartphone.

Exclusion Criteria:

  • Active smoking and any significant comorbid conditions that could inadvertently interfere with study results as determined by the study investigators (i.e. any terminal illness, cancer, HIV, end-stage renal disease, congestive heart failure, severe autoimmune disease or inflammatory bowel disease)
  • Conditions that require bursts of oral corticosteroids
  • Other significant lung diseases (cystic fibrosis, pulmonary hypertension, interstitial lung disease, pulmonary fibrosis among others)
  • Other disease that may mimic asthma, including vocal cord dysfunction, hypersensitivity pneumonitis, or tracheobronchomalacia.

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

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
Change From Baseline in Asthma Control Test
大体时间：Baseline and Week 52
Standardized asthma symptom survey
Baseline and Week 52

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Significant asthma exacerbations (SAEs)
大体时间：Baseline and Week 52
A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for participants receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 observation or 52-week treatment period in each treatment group.
Baseline and Week 52
Change From Baseline in Lung Function
大体时间：Baseline and Week 52
FEV1 % predicted pre- and post-bronchodilator FEV1 absolute (L) pre- and post-bronchodilator FVC % predicted pre- and post-bronchodilator FVC absolute (L) pre- and post-bronchodilator Bronchodilator response: % change in FEV1 after bronchodilator FEV1/FVC ratio: absolute and % predicted Aggregated measure: significant vs non significant bronchodilator reversibility. Significant reversibility defined as greater than or equal to 12% and 200mL increase in FEV1 or FVC
Baseline and Week 52
Global evaluation of treatment effectiveness (GETE)
大体时间：Baseline and Week 52
Standard asthma survey that is scored to assess omalizumab responders
Baseline and Week 52
Change From Baseline in Number of Puffs per Day of Beta Agonist Rescue Medication
大体时间：Baseline and Week 52
Number of inhalations per day averaged out over study duration Number of inhalations per night per month averaged out over study duration
Baseline and Week 52
Change From Baseline in Adherence of Inhaled Corticosteroids
大体时间：Baseline and Week 52
Doses taken/doses prescribed average out over study duration
Baseline and Week 52
Change From Baseline in Steps Per Day
大体时间：Baseline and Week 52
Steps per day average out over study duration
Baseline and Week 52
Change From Baseline in Duration of Exercise Per Day
大体时间：Baseline and Week 52
Minutes exercise per day average out over study duration
Baseline and Week 52
Change From Baseline in Intensity of Exercise Per Day
大体时间：Baseline and Week 52
Minutes exercise/day x average heart rate during the exercise
Baseline and Week 52
Change From Baseline in Duration of Interrupted Sleep per Night
大体时间：Baseline and Week 52
Hours of uninterrupted sleep as recorded by Fitbit device
Baseline and Week 52
Change From Baseline in Number of Awakenings per Night
大体时间：Baseline and Week 52
Number of awakenings per night and/or early morning awakenings as a composite score, as recorded by Fitbit
Baseline and Week 52
Change From Baseline in the Monthly Symptom Questionnaire Scores
大体时间：Baseline and Week 52
Each answer will be scored 1-10 points, depending on the answer, and added to create a survey score. Higher scores indicate poorer asthma control.
Baseline and Week 52

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

National Jewish Health

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)

2021年2月5日

初级完成 (预期的)

2022年7月15日

研究完成 (预期的)

2023年7月15日

研究注册日期

首次提交

2021年1月22日

首先提交符合 QC 标准的

2021年1月22日

首次发布 (实际的)

2021年1月26日

研究记录更新

最后更新发布 (实际的)

2021年6月23日

上次提交的符合 QC 标准的更新

2021年6月21日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HS-3475

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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