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AsthmaTeenAireNCT01891630

Observational Assessment of Baseline Asthma Control in African-American Children

An observational study of Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Asthma
How many people
25 participants
Where
1 siteUnited States
Study dates
Jul 2013to Jan 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: 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.

Who may be able to join

  • Self-identified as African-American
  • Ages 12-17 years
  • Live within convenient driving distance of the UNC Rex Clinic in Raleigh, NC.
  • Physician-diagnosis of moderate-to-severe persistent asthma
  • 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):
Show all 15Show fewer
  • Nighttime awakening with asthma symptoms ≤ 2x/month over the past 6 months
  • Use of short-acting beta2 agonist for symptom control ≤ 2 days /week over the past 6 months
  • 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).
  • 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):
  • Nighttime awakening with asthma symptoms > 2x/month over the past 6 months
  • Use of short-acting beta2 agonist for symptom control > 2 days /week over the past 6 months
  • 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).
  • Baseline FEV1 (pre-albuterol) < 80% of that predicted for gender, ethnicity, age and height (NHANES III predicted set)

Who cannot join

  • Children younger than age 12 and older than 17
  • Children unable to perform spirometry
  • 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)
  • History of bleeding disorder or anemia
  • Subjects and families unwilling to travel to the clinic for the required 6 visits
  • 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.
  • Other uncontrolled health problems
  • Non-English speaking subjects

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rex Hospital

    Raleigh, North Carolina, 27607

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Asthma
Keywords
African American, Asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01891630
Study groupRoleWhat they receive
AA childrenAfrican-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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in lung function assessed by spirometry over a period of 6-8 weeks

    FEV1, FVC and FEV1/FVC ratio

    Measured: at each weekly study visit over 6-8 weeks

Secondary outcomes (1)
  1. Asthma Control Composite Measure

    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.

    Measured: at each weekly study visit over 6-8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01891630
Sponsor's protocol ID
12-1588
Acronym
TeenAire
Status last verified
Sep 2015
First submitted
25 Jun 2013
Last updated
4 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in lung function assessed by spirometry over a period of 6-8 weeks (time frame: at each weekly study visit over 6-8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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