Status:
COMPLETED
Observational Assessment of Baseline Asthma Control in African-American Children
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Environmental Protection Agency (EPA)
Conditions:
Asthma
Eligibility:
All Genders
12-17 years
Brief Summary
To determine if baseline asthma control influences susceptibility to pollutant-induced health effects in African-American children with moderate-to-severe asthma.
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 th...
Eligibility Criteria
Inclusion
- Inclusion Criteria for all subjects:
- 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):
- 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)
- Exclusion criteria for all subjects:
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01891630
Start Date
July 1 2013
End Date
January 1 2015
Last Update
September 4 2015
Active Locations (1)
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1
Rex Hospital
Raleigh, North Carolina, United States, 27607