A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients
2018年11月27日 更新者：Pfizer
A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients
The present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.
研究概览
详细说明
Sequential enrollment
研究类型
观察性的
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
- 孩子
- 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
Patients of Acute Asthma who have been prescribed oral Medrol tablets, will be enrolled
描述
Inclusion Criteria:
- To be eligible for enrollment in this study, patients must be prescribed oral Medrol® tablets (4mg and 16 mg) for acute asthma as per the locally approved prescribing information. The prescription of Medrol® will be separated from the decision to include the patient in the study.
- Medrol® tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol® tablet will necessarily precede and will be independent of the decision to enroll patient into the study. Only those patients who have been prescribed Medrol® tablets will be evaluated for their potential eligibility for the study
- Only those patients, who are ready and willing to sign an informed consent, will be included in the study
- Subject can be contacted through telephone
Exclusion Criteria:
- Based upon history or physical exam in the emergency department (ED) or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema
- Any contraindication to Medrol tablet use. Contraindications of Medrol use are systemic fungal infections and known hypersensitivity to components
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
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Methylprednisolone Group
|
Oral Methylprednisolone tablets given as per locally approved prescribing information
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Relapse within 10 days of hospital discharge (Relapse is defined as unscheduled care at a doctor's office, a clinic, or Emergency Department (ED) for symptoms of persistent or worsening asthma after hospital discharge)
大体时间：10 days after discharge
|
10 days after discharge
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Relapse within 20 days of hospital discharge (Relapse is defined as above for Primary Endpoint).
大体时间：20 days after discharge
|
20 days after discharge
|
|
Change in PEFR (Peak Expiratory Flow Rate measured in Percentage of expected) between start of therapy and first follow up visit.
大体时间：8 - 22 days after discharge
|
8 - 22 days after discharge
|
|
Change in FEV1 (Forced Expiratory Volume in 1 second) between start of therapy and first follow up visit.
大体时间：8 - 22 days after discharge
|
8 - 22 days after discharge
|
|
Proportion of patients controlled for asthma symptoms in the last 7 days after 10 days of hospital discharge
大体时间：10 days after discharge
|
10 days after discharge
|
|
Proportion of patients controlled for asthma symptoms in the last 7 days after 20 days of hospital discharge
大体时间：20 days after discharge
|
20 days after discharge
|
|
Change in frequency in last 24 hours of inhalational Beta 2 agonist therapy between start of therapy and first follow up visit
大体时间：8 - 22 days after discharge
|
8 - 22 days after discharge
|
|
Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit.
大体时间：8 - 22 days after discharge
|
8 - 22 days after discharge
|
|
Summary of adverse events in the study
大体时间：Baseline to 20 days after discharge
|
Baseline to 20 days after discharge
|
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
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2009年10月1日
初级完成 (预期的)
2010年4月1日
研究完成 (预期的)
2010年4月1日
研究注册日期
首次提交
2009年9月3日
首先提交符合 QC 标准的
2009年9月3日
首次发布 (估计)
2009年9月4日
研究记录更新
最后更新发布 (实际的)
2018年11月29日
上次提交的符合 QC 标准的更新
2018年11月27日
最后验证
2018年11月1日
更多信息
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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