Asthma Phenotypes in the Inner City (APIC)
Full Title: asthma Phenotypes in the inner City
Short Title: aPiC
inD Sponsor: Division of allergy, immunology, and Transplantation, national institute of allergy and infectious Diseases
Conducted By: inner-City asthma Consortium
Principal investigator: William W. Busse
Sample Size: 650
Study Population: Children age 6-17 with mild to severe asthma
accrual Period: until sample size is attained as defined in the Manual of operations
Study Design: This is an epidemiologic, multi-center, cross-sectional study to define the phenotypic characteristics of Difficult-to-Treat asthma, among 650 children between the ages of 6 to 17 years, receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis. The study includes 8-9 clinic-based study visits over a period of 13 months. Following a screening visit and a one month run-in period, study eligibility is confirmed by compliance with asthma medications. eligible subjects will then attend 6 additional in-clinic study visits each two months apart. Some participants will have one additional visit to a pulmonary lab to measure lung volumes.
Study Duration: We estimate that this study will take 24 months to complete. each participant will complete 8-9 visits over a period of 13 months.
Study agent Description: Study participants will receive guidelines-based asthma therapy with either Flovent or advair Diskus or equivalent therapy. They will also receive albuterol for use as needed. Study participants will also receive guidelines-based care for rhinitis/rhinosinusitis when indicated via protocol-described assessment.
exploratory objective: exploratory objectives will include examining the pattern of airway inflammation to treatment response. This assessment will include cellular pattern of inflammation, mRna cytokine/chemokine expression, exploratory analyses with microarray, proteomics and epigenetics.
endpoints: This study is not a clinical trial with a single disease outcome or endpoint. our objective is to determine distinct characteristics that will discriminate Difficult-to-Treat from easy-to-Treat asthmatic children in a variety of domains, and to identify specific phenotypes of Difficult-to-Treat asthma.
INCLUSION CRITERIA: (Section 5.1.1)
Participants who meet all of the following criteria are eligible for enrollment. Participants may be
reassessed if not initially eligible. Participants are eligible if they:
1. are male or female aged 6-17 years, inclusive, at Screening (visit -1).
2. have a physician diagnosis of asthma
3. have had 2 or more episodes of short-acting beta-agonist administration within the past 12 months, exclusive of use associated with exercise-induced symptoms.
4. have a primary place of residence located in one of the pre-selected recruitment census tracts
that contains at least 15% of households below the U.S. government poverty level.
5. meet pretreatment eligibility requirements for trial enrollment (acceptable medical history and
physical examination results).
6. have a parent or legal guardian who is willing to sign the written Informed Consent prior to initiation of any study procedure.
7. are willing to sign the assent form, if age appropriate.
8. have some form of medical insurance at the Screening Visit. Coverage must be in effect from Screening through Enrollment in order to be enrolled.