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临床试验/NCT01346852
NCT01346852已完成不适用

Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients

GlaxoSmithKline0 个研究点目标入组 101,437 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
101,437
主要终点
Mean Ratio of Controller Medication to Total Asthma Medication

研究概览

简要总结

The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well as to compare the precision of these tools between adult and pediatric patient populations. This retrospective longitudinal analysis will use 2 different databases: a large managed care database and a large fee for service Medicaid database.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with asthma as determined by ICD-9 codes and asthma drug use
  • at least 4 years of age
  • use of at least 1 controller or at least 5 albuterol prescriptions in 12 months

排除标准

  • Subjects with COPD or treatment for COPD

研究组 & 干预措施

Pediatric participants

Pediatric participants (age 4 to 17) with a diagnosis of asthma

干预措施: Asthma treatment with an asthma-related medication and at least one asthma controller medication (Drug)

Adult participants

Adult participants (age 18 and older) with a diagnosis of asthma

干预措施: Asthma treatment with an asthma-related medication and at least one asthma controller medication (Drug)

结局指标

主要结局

Mean Ratio of Controller Medication to Total Asthma Medication

时间窗: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods

The ratio of controller medication (CM) to total asthma medication (AM), which is well established in predicting future asthma events in adults, was calculated as the ratio of the units of CMs used during the defined period divided by the sum of the units of CMs plus the units of inhaled short-acting beta-agonists used during the same period. A CM is defined as any inhaled corticosteroid containing medication, methylxanthines, leukotriene receptor antagonists, or cromolyn sodium. The ratio is calculated using all CM. Asthma controllers are medications used to treat asthma on a regular basis.

次要结局

  • Mean Number of Short-acting Beta-agonist (SABA) Canisters Used(January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods)

研究者

申办方类型
Industry
责任方
Sponsor

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