Observational Assessment of Baseline Asthma Control in African-American Children

NCT01891630 | Completed

• 1 other identifier: 12-1588
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

African American; Asthma

Outcome Measures

Primary Outcomes (1)

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

  FEV1, FVC and FEV1/FVC ratio

  at each weekly study visit over 6-8 weeks

Secondary Outcomes (1)

• Asthma Control Composite Measure

  at each weekly study visit over 6-8 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Environmental Protection Agency (EPA): collaborator

Study Sites (1)

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michelle Hernandez, MD

  UNC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hernandez

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 3, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

US (1)