NCT00971893撤回不适用
A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- 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)
研究概览
简要总结
The present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.
详细描述
Sequential enrollment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Methylprednisolone Group
干预措施: Oral Methylprednisolone Tablets (Drug)
结局指标
主要结局
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)
时间窗: 10 days after discharge
次要结局
- Relapse within 20 days of hospital discharge (Relapse is defined as above for Primary Endpoint).(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.(8 - 22 days after discharge)
- Proportion of patients controlled for asthma symptoms in the last 7 days after 10 days of hospital discharge(10 days after discharge)
- Proportion of patients controlled for asthma symptoms in the last 7 days after 20 days of hospital discharge(20 days after discharge)
- Change in FEV1 (Forced Expiratory Volume in 1 second) between start of therapy and first follow up visit.(8 - 22 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(8 - 22 days after discharge)
- Summary of adverse events in the study(Baseline to 20 days after discharge)
- Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit.(8 - 22 days after discharge)
研究者
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