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Observational Assessment of Baseline Asthma Control in African-American Children (TeenAire)

2015年9月2日 更新者:Michelle Hernandez, MD、University of North Carolina, Chapel Hill

Observational Assessment of Baseline Asthma Control as a Susceptibility Factor for Air Pollution Health Effects in African-American Children With Moderate-severe Asthma (Teen AIRE Study)

To determine if baseline asthma control influences susceptibility to pollutant-induced health effects in African-American children with moderate-to-severe asthma.

研究概览

地位

完全的

条件

详细说明

In the general public, certain sub-populations are at higher risk for adverse health effects due to air pollution exposure. Asthmatics have been identified as one such susceptible population due to the observed association of elevated air pollution levels and increased incidences of acute asthma exacerbations as evidenced by decreased lung function values and respiratory symptoms, shortness of breath, emergency department (ED) visits, and hospitalizations (6-13). A study conducted by Mar et al (2004) reported that health outcomes associated with coarse particulate matter (PM2.5-10) were more notable in children with asthma than in adults with asthma (14) and a large epidemiological study of asthmatic children in the Northeastern US showed that asthma morbidity on high ozone days was consistently highest among children age 6 to 18 years (15). Furthermore, children with persistent asthma (requiring daily maintenance medication) were shown to be at increased risk of respiratory symptoms and rescue medication use after ambient ozone exposure compared to children with mild intermittent asthma (16). Together, these studies demonstrate an additional level of susceptibility to air pollution in children compared with adults and in children with persistent asthma compared with mild intermittent asthma.

African-American patients appear to be particularly susceptible to asthma-related complications, with rates of asthma-related emergency department visits, hospitalizations, and death approximately 2 to 3 times the rates found in Caucasian subjects (17) . Furthermore, a higher proportion of African-American asthmatics have poorly-controlled asthma compared to non-African-American asthmatics (18). In a recent pediatric study, very poorly controlled asthmatics had an increased risk of asthma-related hospitalization, emergency department visits, or corticosteroid burst (OR, 6.4; 95% CI, 1.2-34.5) compared with those whose asthma was under better control over a 2-year period (19).

The goal of this panel study is to determine if African-American children with poorly-controlled moderate-to-severe persistent asthma are at increased risk for cardiopulmonary effects as a result of ambient air pollution exposure compared to age- and race-matched well-controlled moderate-to-severe asthmatic children. The primary cohort for this panel study will be African-American children between the ages of 12-17 years with moderate-to-severe asthma (divided between the study populations of poorly-controlled asthma and well-controlled asthma). Since this study is exclusively focused on an African-American population, it is not designed to address the effect of race/ethnicity on baseline asthma control. Volunteers will be recruited primarily from the UNC Pediatric Pulmonary clinic and the UNC Allergy/Immunology clinic located at Rex Hospital in Raleigh, NC in which Dr. Hernandez is an attending physician. These volunteers are well-characterized asthmatics followed regularly by a pediatric pulmonologist (Dr. Ceila Loughlin) and by a pediatric allergist (Dr. Michelle Hernandez) at the Rex location. In order to ensure that the two cohorts experience equivalent daily exposures to ambient air pollutants, the study population will be recruited from a defined geographical region within a reasonable driving distance of the Rex Hospital and in relative proximity to the state-operated monitoring station for ambient air pollutants.

Establishing a relationship between asthma control and adverse health outcomes in response to air pollution exposure will provide health care providers and parents of children with moderate-to-severe asthma the information necessary to take proactive action on high air pollution days as they are communicated to the public through color-coded days based on the National Ambient Air Quality Standards (NAAQS) established by the EPA. If asthma control is determined in this study to be a risk factor for susceptibility, future work will be directed toward establishing the mechanism underlying the susceptibility which may then lead to the potential design of new therapies or intervention strategies.

研究类型

观察性的

注册 (实际的)

25

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

    • North Carolina
      • Raleigh、North Carolina、美国、27607
        • Rex Hospital

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

12年 至 17年 (孩子)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

We will enroll a maximum of 60 African-American children with moderate-to-severe persistent asthma in which half of the cohort will have well-controlled asthma and the other half will have poorly-controlled asthma (defined by NHLBI guidelines). Participants will be of both genders, ages 12-17 years old, and live within a convenient driving distance from the study site located within the UNC Pediatric Pulmonary and UNC Pediatric Allergy and Immunology Subspecialty clinics at Rex Hospital located in Raleigh, NC.

描述

Inclusion Criteria for all subjects:

  1. Self-identified as African-American
  2. Ages 12-17 years
  3. Live within convenient driving distance of the UNC Rex Clinic in Raleigh, NC.
  4. Physician-diagnosis of moderate-to-severe persistent asthma
  5. Current treatment with appropriate therapy for moderate-to-severe persistent asthma symptoms as per the NHLBI guidelines including: Daily controller medication use for asthma requiring at least a medium-dose inhaled corticosteroids (ICS) or a low dose ICS + long-acting beta2 agonist (LABA) combination. Subjects may use daily or every other day oral corticosteroids for control of asthma symptoms

Inclusion criteria for well-controlled asthmatics (from NHLBI guidelines):

  1. Nighttime awakening with asthma symptoms ≤ 2x/month over the past 6 months
  2. Use of short-acting beta2 agonist for symptom control ≤ 2 days /week over the past 6 months
  3. Asthma Control Test score >19. The Asthma Control Test is a standardized clinical tool to assess asthma control over the previous 4 week period (attached).
  4. Baseline FEV1(pre-albuterol) > 80% of that predicted for gender, ethnicity, age and height (NHANES III predicted set)

Inclusion criteria for poorly-controlled asthmatics (from NHLBI guidelines):

  1. Nighttime awakening with asthma symptoms > 2x/month over the past 6 months
  2. Use of short-acting beta2 agonist for symptom control > 2 days /week over the past 6 months
  3. Asthma Control Test score <19. The Asthma Control Test is a standardized clinical tool to assess asthma control over the previous 4 week period (attached).
  4. Baseline FEV1 (pre-albuterol) < 80% of that predicted for gender, ethnicity, age and height (NHANES III predicted set)

Exclusion criteria for all subjects:

  1. Children younger than age 12 and older than 17
  2. Children unable to perform spirometry
  3. Medical history or underlying health problems that may preclude participation in the protocol per the study physician (including but not limited to cystic fibrosis, chronic bronchitis, recurrent pneumonia, immunodeficiency, hematologic disorders)
  4. History of bleeding disorder or anemia
  5. Subjects and families unwilling to travel to the clinic for the required 6 visits
  6. Unwilling or unable to refrain from the following medications for the week prior to the study as well as the week of the study including fish oil; anti-inflammatory agents such as ibuprofen (Advil, Motrin), naproxen (Aleve) or aspirin as needed**. Acetaminophen (Tylenol) is allowed.**If the child requires anti-inflammatory medications for a fever or joint/muscle pain, in the week prior to the study visit, all subsequent visits may be rescheduled.
  7. Other uncontrolled health problems
  8. Non-English speaking subjects

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

队列和干预

团体/队列
AA children
African-American children with moderate-to-severe asthma living in a defined geographical area whose asthma is poorly controlled, and up to 30 moderate-to-severe African-American asthmatic children living in the same defined geographical area whose asthma is well controlled.

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
Change in lung function assessed by spirometry over a period of 6-8 weeks
大体时间:at each weekly study visit over 6-8 weeks
FEV1, FVC and FEV1/FVC ratio
at each weekly study visit over 6-8 weeks

次要结果测量

结果测量
措施说明
大体时间
Asthma Control Composite Measure
大体时间:at each weekly study visit over 6-8 weeks

The following measures will be used to assess overall asthma control:

  1. . asthma control questionnaire score.
  2. . Number of urgent care visits for asthma during the interval study period.
  3. . requirement for oral steroid use for asthma during the interval study period.
at each weekly study visit over 6-8 weeks

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:Michelle Hernandez, MD、UNC

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

2013年7月1日

初级完成 (实际的)

2015年1月1日

研究完成 (实际的)

2015年1月1日

研究注册日期

首次提交

2013年6月25日

首先提交符合 QC 标准的

2013年6月28日

首次发布 (估计)

2013年7月3日

研究记录更新

最后更新发布 (估计)

2015年9月4日

上次提交的符合 QC 标准的更新

2015年9月2日

最后验证

2015年9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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