Pharmacogenetics of b2-Agonists in Asthma.
2018年2月20日 更新者：Kathryn Blake, PharmD、Nemours Children's Clinic
This study will help to find out if having a certain genetic makeup influences how a person with asthma responds to salmeterol, one of the two drugs in Advair(R).
研究概览
地位
完全的
条件
详细说明
Patients are being asked to take part in this research study because they have asthma. This clinical research study is being done to see if an asthmatic's gene make-up (DNA is made up of genes) affects the way they respond to a particular asthma medication called salmeterol. Certain genes make people tall or short. Certain genes give people brown or black hair. Similarly, certain genes may be associated with the way patients respond to asthma medications.
Salmeterol xinafoate (a long acting bronchodilator) and fluticasone propionate (an inhaled corticosteroid) are the medicines contained in Advair Diskus. During this study, patients with asthma will receive fluticasone inhaler (called Flovent) and Advair Diskus. The investigators want to find out if patients with asthma with certain genes respond in different ways to the salmeterol in Advair Diskus. The investigators also want to find out if patients with asthma with certain genes who are treated with salmeterol for two weeks have their airways open up less than usual when they use albuterol.
研究类型
观察性的
注册 (实际的)
88
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。
学习地点
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Florida
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Jacksonville、Florida、美国、32207
- Nemours Children's Clinic
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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
10年 及以上 (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
The study population was Whites and African Americans with specific ADRB2 diplotypes aged 10 years or older with physician diagnosed asthma according to American Thoracic Society criteria for at least 3 months, forced expiratory volume in the first second (FEV1) >= 60% of predicted normal values for age, height, and gender, and a methacholine challenge test provocative concentration (20% fall in FEV1) of <=12]mg/ml.
描述
Inclusion Criteria:
- Diplotype: Whites with specific diplotype and African Americans with specific diplotypes.
- Gender: Male or female. Women are eligible if they are not pregnant or lactating. Females subjects of childbearing potential will undergo a urine pregnancy test prior to each methacholine challenge test.
- Age: 10 years and older.
- Asthma Diagnosis: Physician diagnosed asthma according to American Thoracic Society criteria for at least 3 months.
- Asthma Therapy: There is no requirement for previous asthma therapy to be included in this study.
- Asthma Severity: forced expiratory volume in the first second (FEV1) must be >= 60% of predicted normal values for age, height, and gender.
- methacholine challenge test provocative concentration (20% fall in FEV1) of <=12]mg/ml.
Exclusion Criteria:
- History of life-threatening asthma: Any episode of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
- Asthma instability: Hospitalization for asthma within 3 months of Visit 1.
- Concurrent respiratory disease: Any respiratory disease other than asthma.
- Sensitivities: Sensitivities to methacholine, Flovent® MDI, ipratropium bromide, albuterol, or Advair Diskus® that would put the safety of the subject at risk.
- Respiratory Tract Infection: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 2 weeks prior to Visit 1.
- Expected exposure to pollen allergen to which the patient is sensitive (by medical history of symptoms) during the 29 day study period. These patients can be studied when pollen exposure to which they are sensitive will not occur.
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：案例交叉
- 时间观点：预期
队列和干预
团体/队列 |
|---|
|
Whites ADRB2:ARG16ARG
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
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|
Whites ADRB2:GLY16GLY
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
|
|
African American ADRB2:ARG16ARG
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
|
|
African American ADRB2:GLY16GLY
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
|
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 |
|---|---|---|
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Log10 PC20 to Methacholine After Visit 2
大体时间：Visit 2:12 hours after last dose of Flovent
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Visit 2 log10 PC20 after receiving 2 weeks of Flovent
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Visit 2:12 hours after last dose of Flovent
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Log10 PC20 to Methacholine After Visit 3
大体时间：Visit 3:12 hours after the last dose of Advair
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Visit 3 Log10 PC20 after receiving 2 weeks of Advair
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Visit 3:12 hours after the last dose of Advair
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Log10 PC20 to Methacholine After Visit 4
大体时间：36 hours after the last dose of Advair
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Visit 4 log10 PC20 to Methacholine after stopping Advair
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36 hours after the last dose of Advair
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Bronchodilator Response to Methacholine (PC20) After Visit 2
大体时间：0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent.
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The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge.
2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response).
FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes.
Participants had received Flovent for 2 weeks at Visit 2.
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0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent.
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Bronchodilator Response Following Methacholine Challenge at Visit 3
大体时间：0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair
|
The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge.
2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response).
FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes.
Participants had received Advair for 2 weeks at Visit 3.
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0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair
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Bronchodilator Response Following Methacholine Challenge at Visit 4
大体时间：0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair
|
The area under the curve (AUC) bronchodilator response after Visit 4 methacholine challenge.
2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response).
FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes.
Participants had discontinued Advair for 36 hours.
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0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair
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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。
调查人员
- 首席研究员：Kathryn Blake, Pharm.D.、Nemours Children's Clinic
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
2007年9月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2008年6月27日
首先提交符合 QC 标准的
2008年7月1日
首次发布 (估计)
2008年7月2日
研究记录更新
最后更新发布 (实际的)
2018年2月22日
上次提交的符合 QC 标准的更新
2018年2月20日
最后验证
2018年2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.