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1.  Asthma Outcomes: Pulmonary Physiology 
Outcomes of pulmonary physiology have a central place in asthma clinical research.
At the request of National Institutes of Health (NIH) institutes and other federal agencies, an expert group was convened to provide recommendations on the use of pulmonary function measures as asthma outcomes that should be assessed in a standardized fashion in future asthma clinical trials and studies to allow for cross-study comparisons.
Our subcommittee conducted a comprehensive search of PubMed to identify studies that focused on the validation of various airway response tests used in asthma clinical research. The subcommittee classified the instruments as core (to be required in future studies), supplemental (to be used according to study aims and in a standardized fashion), or emerging (requiring validation and standardization). This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011.
A list of pulmonary physiology outcomes that applies to both adults and children older than 6 years was created. These outcomes were then categorized into core, supplemental, and emerging. Spirometric outcomes (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC], and FEV1/FVC) are proposed as core outcomes for study population characterization, for observational studies, and for prospective clinical trials. Bronchodilator reversibility and pre- and post-bronchodilator FEV1 also are core outcomes for study population characterization and observational studies.
The subcommittee considers pulmonary physiology outcomes of central importance in asthma and proposes spirometric outcomes as core outcomes for all future NIH-initiated asthma clinical research.
PMCID: PMC4263032  PMID: 22386510
Spirometry; airway responsiveness; peak expiratory flow monitoring; lung volumes; gas exchange
2.  Sleep disordered breathing is associated with asthma severity in children 
The Journal of pediatrics  2011;160(5):736-742.
To examine the relationship between obesity, sleep disordered breathing (SDB), and asthma severity in children. We hypothesized that obesity and SDB (intermittent nocturnal hypoxia and habitual snoring) are associated with severe asthma at one year of follow-up.
Study design
Children (4 to 18 years) were recruited sequentially from a specialty asthma clinic, and underwent physiological, anthropometric, and biochemical assessments at enrollment. Asthma severity was determined after one year of follow-up and guidelines-based treatment, using a composite measure of level of controller medication, symptom burden, and health care utilization. Multivariable logistic regression was used to examine adjusted associations of SDB and obesity with asthma severity at 12-month follow-up.
Among 108 participants (mean age 9.1 ± 3.4 years, 45.4% African-American, 67.6% male), obesity and SDB were common, affecting 42.6% and 29.6% of participants respectively. After adjusting for obesity, race, and sex, children with SDB had a 3.62-fold increased odds of having severe asthma at follow up (95% CI: 1.26, 10.40). Obesity was not associated with asthma severity.
We identify SDB as a modifiable risk factor for severe asthma after one year of specialty asthma care. Future studies are needed to determine if treating SDB improves asthma morbidity.
PMCID: PMC3975834  PMID: 22133422
sleep disordered breathing; obesity; asthma
3.  The In Vivo Adherence Intervention For at Risk Adolescents With Asthma: Report of a Randomized Pilot Trial 
Journal of Pediatric Psychology  2011;37(4):390-403.
Objective Low-income and minority adolescents are at high risk for poor asthma outcomes, due in part to adherence. We tested acceptability, feasibility, and effect sizes of an adherence intervention for low socioeconomic status (SES) minority youth with moderate- and severe-persistent asthma. Design and Methods Single-site randomized pilot trial: intervention (n = 12; asthma education, motivational interviewing, problem-solving skills training, 1 month cell-phone with tailored text messaging) versus control (n = 14; asthma education; cell-phone without tailored messaging). Calculated effect-sizes of relative change from baseline (1 and 3 months). Results Intervention was judged acceptable and feasible by participants. Participants (12–18 years, mean = 15.1, SD = 1.67) were 76.9% African-American, 80.7% public/no insurance. At 1 and 3 months, asthma symptoms (Cohen's d's = 0.40, 0.96) and HRQOL (PedsQL™; Cohen's d's = 0.23, 1.25) had clinically meaningful medium to large effect sizes. Conclusions This intervention appears promising for at-risk youth with moderate- and severe-persistent asthma.
PMCID: PMC3334534  PMID: 22167121
asthma; chronic illness; disparities; effect size; intervention outcome; quality of life
4.  Asthma Control, Adiposity and Adipokines among Inner-City Adolescents 
There is an association between adiposity and asthma prevalence, but the relationship to asthma control is unclear.
To understand the relationships among adiposity, gender, and asthma control in inner-city adolescents with asthma.
We prospectively followed 368 adolescents with moderate to severe asthma (ages 12–20 years) living in 10 urban areas for one year. Asthma symptoms and exacerbations were recorded, and pulmonary function and exhaled nitric oxide were measured every 6 weeks. Adiposity measures (BMI, DEXA scans) were made, and blood was collected for allergy markers, adiponectin, leptin, TNF-α, IL-6 and CRP.
More than 60% of females and 50% of males were above the 85th percentile of BMI-for-age. Higher BMI was associated with more symptom days (R= 0.18, P<0.01) and exacerbations (R=0.18, P=0.06) among females only. Adiponectin was inversely related to asthma symptoms (R=− 0.18, P<0.05) and exacerbations (R=− 0.20, P<0.05) and positively with FEV1/FVC (R=0.15, P<0.05) in males only, independent of body size. There was no relationship between adiposity or adipokines and total IgE, blood eosinophils and exhaled nitric oxide. DEXA provided little additional value in relating adiposity to asthma outcome in this population of adolescents.
Adiposity is associated with poorer asthma control in females. Adiponectin is associated with improved asthma control in males.
PMCID: PMC3596816  PMID: 20226295
Obesity; Asthma; Adipokines; Leptin; Adiponectin
5.  The Greater Cincinnati Pediatric Clinic Repository: A Novel Framework for Childhood Asthma and Allergy Research 
Allergic disorders, including asthma, allergic rhinitis, atopic dermatitis, eosinophilic esophagitis, and food allergy, are a major global health burden. The study and management of allergic disorders is complicated by the considerable heterogeneity in both the presentation and natural history of these disorders. Biorepositories serve as an excellent source of data and biospecimens for delineating subphenotypes of allergic disorders, but such resources are lacking.
In order to define subphenotypes of allergic disease accurately, we established an infrastructure to link and efficiently utilize clinical and epidemiologic data with biospecimens into a single biorepository called the Greater Cincinnati Pediatric Clinic Repository (GCPCR). Children with allergic disorders as well as healthy controls are followed longitudinally at hospital clinic, emergency department, and inpatient visits. Subjects' asthma, allergy, and skin symptoms; past medical, family, social, diet, and environmental histories; physical activity; medication adherence; perceived quality of life; and demographics are ascertained. DNA is collected from all participants, and other biospecimens such as blood, hair, and nasal epithelial cells are collected on a subset.
To date, the GCPCR has 6,317 predominantly Caucasian and African American participants, and 93% have banked DNA. This large sample size supports adequately powered genetic, epidemiologic, environmental, and health disparities studies of childhood allergic diseases.
The GCPCR is a unique biorepository that is continuously evaluated and refined to achieve and maintain rigorous clinical phenotype and biological data. Development of similar disease-specific repositories using common data elements is necessary to enable studies across multiple populations of comprehensively phenotyped patients.
PMCID: PMC3377950  PMID: 22768387
6.  Comparison of measures of marker informativeness for ancestry and admixture mapping 
BMC Genomics  2011;12:622.
Admixture mapping is a powerful gene mapping approach for an admixed population formed from ancestral populations with different allele frequencies. The power of this method relies on the ability of ancestry informative markers (AIMs) to infer ancestry along the chromosomes of admixed individuals. In this study, more than one million SNPs from HapMap databases and simulated data have been interrogated in admixed populations using various measures of ancestry informativeness: Fisher Information Content (FIC), Shannon Information Content (SIC), F statistics (FST), Informativeness for Assignment Measure (In), and the Absolute Allele Frequency Differences (delta, δ). The objectives are to compare these measures of informativeness to select SNP markers for ancestry inference, and to determine the accuracy of AIM panels selected by each measure in estimating the contributions of the ancestors to the admixed population.
FST and In had the highest Spearman correlation and the best agreement as measured by Kappa statistics based on deciles. Although the different measures of marker informativeness performed comparably well, analyses based on the top 1 to 10% ranked informative markers of simulated data showed that In was better in estimating ancestry for an admixed population.
Although millions of SNPs have been identified, only a small subset needs to be genotyped in order to accurately predict ancestry with a minimal error rate in a cost-effective manner. In this article, we compared various methods for selecting ancestry informative SNPs using simulations as well as SNP genotype data from samples of admixed populations and showed that the In measure estimates ancestry proportion (in an admixed population) with lower bias and mean square error.
PMCID: PMC3276602  PMID: 22185208
7.  Adherence to Pediatric Asthma Treatment in Economically Disadvantaged African-American Children and Adolescents: An Application of Growth Curve Analysis 
Journal of Pediatric Psychology  2009;35(4):394-404.
Objectives The primary aims of the study were to: (a) describe the trajectories of adherence to daily inhaled corticosteroid (ICS) medication for a year in economically disadvantaged, African-American youth with asthma based on growth curve modeling; and (b) test the relationship of treatment adherence to symptom control, quick-relief medication, and healthcare utilization. Methods This prospective study measured adherence to daily ICS treatment using electronic monitoring in 92 children and adolescents with moderate to severe asthma for 9–12 months and assessed clinical outcomes, including asthma-related symptoms, quick-relief medication, and healthcare utilization. Results Youth showed a decrement in treatment adherence to less than half of prescribed corticosteroid treatment over the course of the study, which related to increased healthcare utilization (p < .04), but not to asthma symptoms or albuterol use. Conclusion Economically disadvantaged youth with asthma demonstrate high rates of chronic nonadherence that warrant identification and intervention to reduce asthma-related healthcare utilization.
PMCID: PMC2858436  PMID: 19710251
health care utilization; pediatric asthma; treatment adherence
8.  Obesity and obesity related co-morbidities in a referral population of children with asthma 
Pediatric pulmonology  2009;44(9):877-884.
Although there is mounting evidence that childhood obesity is a risk factor for incident asthma, it remains unclear if there is a distinct “asthma-obesity” phenotype. This study characterized body composition, obesity related co-morbidities, and traditional risk factors for asthma in a cohort of children referred for asthma management in a pulmonary clinic. We hypothesized that children with asthma and obesity would have distinct risk factors and co-morbidities, particularly with respect to metabolic and sleep abnormalities.
Participants and Methods
116 asthmatic children ages 4 to 18 years underwent comprehensive measurements of common asthma risk factors as well as measurements of obesity-related morbidities, including lung function tests, atopy, and assessments of sleep (overnight oximetry and actigraphy), physical activity (accelerometry), and metabolism. Characteristics of children who were obese (BMI ≥ 95th percentile) were compared to those who were not obese (BMI < 95th percentile).
Obesity was present in 44% of participants. Obese participants had similar rates of atopy and family history of atopy, lung function, and asthma control at enrollment as their non-obese peers. A significantly higher proportion of obese participants had metabolic syndrome (23% vs 0%) and habitual snoring (60% vs 33%) compared to non-obese participants; insufficient sleep and nocturnal desaturations tended to be more prevalent among obese subjects.
Obesity and obesity related co-morbidities were common in a referral population of children with asthma. The specific influence of metabolic abnormalities on asthma morbidity and management is still uncertain and likely will need to be addressed in prospective studies.
PMCID: PMC2940418  PMID: 19639627
obesity; asthma
9.  Adding Exhaled Nitric Oxide to Guideline-based Asthma Treatment in Inner-City Adolescents and Young Adults: a randomized controlled trial 
Lancet  2008;372(9643):1065-1072.
Preliminary evidence is equivocal regarding the role of exhaled nitric oxide in clinical asthma management. This study evaluates the usefulness of eNO as an adjunct to asthma guidelines-based clinical care among inner-city adolescents and young adults.
A randomized, double-blind, parallel-group trial was conducted with 546 inner-city participants, aged 12–20 years, with persistent asthma ( Identifier: NCT00114413). A run-in characterization period of 3 weeks on an initial controller regimen preceded a 46-week double-blind treatment strategy. Participants were randomized to either, treatment based on NAEPP guidelines alone (Reference Group) or the guidelines plus FENO measurements (FENO Group). Primary outcome was asthma symptom days and secondary outcome was acute asthma exacerbations.
During the 46-week treatment period, the number of asthma symptom days, pulmonary function, unscheduled care visits, and hospitalizations did not differ between the treatment groups (mean asthma symptom days were 1.93 [95% CI 1.74-2.11] in the FENO group vs. 1.89 [1.71-1.74] in the control group; difference 0.04 [-0.29-0.22], p=0.7796). The FENO Group received a significantly higher inhaled corticosteroid dose (118.9 mcg/day difference, 95% CI: 48.5-189.3, P=0.0010) as compared to the Reference Group. Asthma symptoms remained low in both groups following randomization with 57% (306/534) of the participants well controlled for at least 80% of visits..
A coordinated asthma management program facilitated achieving good control in the majority of participants. The addition of FENO as a control indicator resulted in a higher dose of inhaled corticosteroids without a clinically important improvement in symptomatic asthma control.
PMCID: PMC2610850  PMID: 18805335
asthma; biomarker; exhaled nitric oxide; inhaled corticosteroid; inner-city asthma; long-acting ß2-agonist; medication adherence; asthma exacerbations; asthma outcomes; asthma guidelines; impairment; risk
10.  Reduction in Asthma Morbidity in Children as a Result of Home Remediation Aimed at Moisture Sources 
Environmental Health Perspectives  2006;114(10):1574-1580.
Home dampness and the presence of mold and allergens have been associated with asthma morbidity. We examined changes in asthma morbidity in children as a result of home remediation aimed at moisture sources.
In this prospective, randomized controlled trial, symptomatic, asthmatic children (n = 62), 2–17 years of age, living in a home with indoor mold, received an asthma intervention including an action plan, education, and individualized problem solving. The remediation group also received household repairs, including reduction of water infiltration, removal of water-damaged building materials, and heating/ventilation/air-conditioning alterations. The control group received only home cleaning information. We measured children’s total and allergen-specific serum immuno-globulin E, peripheral blood eosinophil counts, and urinary cotinine. Environmental dust samples were analyzed for dust mite, cockroach, rodent urinary protein, endotoxin, and fungi. The follow-up period was 1 year.
Children in both groups showed improvement in asthma symptomatic days during the preremediation portion of the study. The remediation group had a significant decrease in symptom days (p = 0.003, as randomized; p = 0.004, intent to treat) after remodeling, whereas these parameters in the control group did not significantly change. In the postremediation period, the remediation group had a lower rate of exacerbations compared with control asthmatics (as treated: 1 of 29 vs. 11 of 33, respectively, p = 0. 003; intent to treat: 28.1% and 10.0%, respectively, p = 0.11).
Construction remediation aimed at the root cause of moisture sources and combined with a medical/behavioral intervention significantly reduces symptom days and health care use for asthmatic children who live in homes with a documented mold problem.
PMCID: PMC1626393  PMID: 17035145
asthma; children; damp housing; home remediation; indoor mold

Results 1-10 (10)