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临床试验/NCT02499887
NCT02499887终止不适用

Repeat Emergency Department Visits Among Patients With Asthma and COPD

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2016年1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
终止
入组人数
6
试验地点
1
主要终点
Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge

研究概览

简要总结

The purpose of the proposed study is to determine whether the addition of inhaled corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat emergency department (ED) visits among patients treated for acute exacerbations of asthma and COPD discharged from the emergency department to home. The investigators hypothesize that patients treated with inhaled corticosteroids in addition to oral corticosteroids and albuterol will have lower rates of 30-day return visits to the emergency department than those patients treated with oral corticosteroids and albuterol only.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Treated in the ED at the Erie County Medical Center (ECMC) for acute symptoms of asthma or COPD during the study period
  • Patient age ≥ 18 years
  • Resident of the City of Buffalo or Erie County
  • Discharged to home
  • Patient expresses willingness to return to ECMC or own primary care provider for follow-up visits
  • Able to provide informed consent
  • Able to comprehend English language

排除标准

  • Received oral or inhaled corticosteroids in the week before ED presentation
  • Presented to the ED primarily for prescription refills
  • Complicated comorbid conditions (e.g. renal disease, cardiovascular disease, CHF, HIV)
  • Admitted to ECMC or discharged to another facility
  • Previously enrolled during a prior visit to the ED during the study period
  • For female patients--pregnant or pregnancy status indeterminate
  • Antibiotics are prescribed to treat current asthma/COPD exacerbation.

研究组 & 干预措施

Standard of Care

Active Comparator

Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED)

Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.

干预措施: albuterol (Drug)

Standard of Care

Active Comparator

Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED)

Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.

干预措施: Prednisone (Drug)

Treatment

Experimental

Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days

Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.

干预措施: beclamethasone dipropionate (Drug)

Treatment

Experimental

Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days

Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.

干预措施: albuterol (Drug)

Treatment

Experimental

Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days

Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.

干预措施: Prednisone (Drug)

结局指标

主要结局

Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge

时间窗: 30 days

Subjects' medical records will be reviewed for the 30 day period following ED discharge to determine if they return to the treating ED or another regional ED for treatment of an acute asthma/COPD exacerbation. Regional ED records will be queried by use of data maintained by HEALTHeLINK, our regional health information organization system. This will allow for more complete capture of ED return visits that could be obtained by looking only at a single ED.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Lindstrom

Research Assistant Professor

State University of New York at Buffalo

研究点 (1)

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