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1.
J Allergy Clin Immunol ; 143(2): 746-754.e2, 2019 02.
Article in English | MEDLINE | ID: mdl-30055181

ABSTRACT

BACKGROUND: Children with asthma are at increased risk for experiencing health and educational disparities because of increased school absence. School nurses are well positioned to support asthma management and improve school attendance. OBJECTIVE: We sought to implement and assess the effect of the Building Bridges for Asthma Care Program on improving school attendance and measures of asthma control. METHODS: Children with asthma (age, 5-14 years) in the Denver Public School System (n = 240) and the Hartford Public School System (n = 223) were enrolled in the Building Bridges Program during the 2013-2014 and 2014-2015 school years and followed until the end of the second school year. The primary outcome was school absence, with secondary outcomes, including asthma control, measured based on Childhood Asthma Control Test or the Asthma Control Test scores and rescue inhaler use. RESULTS: Participants experienced a 22% absolute decrease in school absenteeism, the number of children with an Asthma Control Test/Childhood Asthma Control Test score of less than the control threshold of 20 decreased from 42.7% to 28.8%, and bronchodilator use greater than 2 times per week decreased from 35.8% to 22.9% (all changes were significant, P < .01). CONCLUSIONS: Children enrolled in the Building Bridges for Asthma Care Program experienced reduced school absence and improved asthma control.


Subject(s)
Asthma/epidemiology , Healthcare Disparities/statistics & numerical data , Population , Program Evaluation/statistics & numerical data , Urban Population , Absenteeism , Adolescent , Child , Child, Preschool , Female , Health Services Accessibility , Humans , Male , Schools , United States/epidemiology
2.
J Sch Nurs ; 36(3): 168-180, 2020 Jun.
Article in English | MEDLINE | ID: mdl-30336726

ABSTRACT

Asthma imposes tremendous burden on children, families, and society. Successful management requires coordinated care among children, families, health providers, and schools. Building Bridges for Asthma Care Program, a school-centered program to coordinate care for successful asthma management, was developed, implemented, and evaluated. The program consists of five steps: (1) identify students with asthma; (2) assess asthma risk/control; (3) engage the family and student at risk; (4) provide case management and care coordination, including engagement of health-care providers; and (5) prepare for next school year. Implementation occurred in 28 schools from two large urban school districts in Colorado and Connecticut. Significant improvements were noted in the proportions of students with completed School Asthma Care Plans, a quick-relief inhaler at school, Home Asthma Action/Treatment Plans and inhaler technique (p < .01 for all variables). Building Bridges for Asthma Care was successfully implemented extending asthma care to at-risk children with asthma through engagement of schools, health providers, and families.


Subject(s)
Asthma/prevention & control , Program Development , School Health Services/organization & administration , School Nursing/methods , Adult , Case Management/organization & administration , Child , Colorado , Community Health Services , Connecticut , Disease Management , Family , Humans
3.
N Engl J Med ; 375(9): 840-9, 2016 09 01.
Article in English | MEDLINE | ID: mdl-27579634

ABSTRACT

BACKGROUND: Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children. It is unknown whether the concomitant use of inhaled glucocorticoids with LABAs mitigates those risks. This trial prospectively evaluated the safety of the LABA salmeterol, added to fluticasone propionate, in a fixed-dose combination in children. METHODS: We randomly assigned, in a 1:1 ratio, children 4 to 11 years of age who required daily asthma medications and had a history of asthma exacerbations in the previous year to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization), as assessed in a time-to-event analysis. The statistical design specified that noninferiority would be shown if the upper boundary of the 95% confidence interval of the hazard ratio for the primary safety end point was less than 2.675. The main efficacy end point was the first severe asthma exacerbation that led to treatment with systemic glucocorticoids, as assessed in a time-to-event analysis. RESULTS: Among the 6208 patients, 27 patients in the fluticasone-salmeterol group and 21 in the fluticasone-alone group had a serious asthma-related event (all were hospitalizations); the hazard ratio with fluticasone-salmeterol versus fluticasone alone was 1.28 (95% confidence interval [CI], 0.73 to 2.27), which showed the noninferiority of fluticasone-salmeterol (P=0.006). A total of 265 patients (8.5%) in the fluticasone-salmeterol group and 309 (10.0%) in the fluticasone-alone group had a severe asthma exacerbation (hazard ratio, 0.86; 95% CI, 0.73 to 1.01). CONCLUSIONS: In this trial involving children with asthma, salmeterol in a fixed-dose combination with fluticasone was associated with the risk of a serious asthma-related event that was similar to the risk with fluticasone alone. (Funded by GlaxoSmithKline; VESTRI ClinicalTrials.gov number, NCT01462344 .).


Subject(s)
Asthma/drug therapy , Bronchodilator Agents/administration & dosage , Fluticasone-Salmeterol Drug Combination/administration & dosage , Fluticasone/administration & dosage , Administration, Inhalation , Adrenergic beta-1 Receptor Agonists/administration & dosage , Adrenergic beta-1 Receptor Agonists/adverse effects , Adrenergic beta-2 Receptor Agonists/administration & dosage , Adrenergic beta-2 Receptor Agonists/adverse effects , Bronchodilator Agents/adverse effects , Child , Child, Preschool , Delayed-Action Preparations , Double-Blind Method , Female , Fluticasone/adverse effects , Fluticasone-Salmeterol Drug Combination/adverse effects , Humans , Male , Metered Dose Inhalers , Proportional Hazards Models
4.
J Allergy Clin Immunol ; 141(5): 1870-1879.e14, 2018 05.
Article in English | MEDLINE | ID: mdl-29198587

ABSTRACT

BACKGROUND: Bedroom allergen exposures contribute to allergic disease morbidity because people spend considerable time in bedrooms, where they come into close contact with allergen reservoirs. OBJECTIVE: We investigated participant and housing characteristics, including sociodemographic, regional, and climatic factors, associated with bedroom allergen exposures in a nationally representative sample of the US population. METHODS: Data were obtained from National Health and Nutrition Examination Survey 2005-2006. Information on participant and housing characteristics was collected by using questionnaires and environmental assessments. Concentrations of 8 indoor allergens (Alt a 1, Bla g 1, Can f 1, Fel d 1, Der f 1, Der p 1, Mus m 1, and Rat n 1) in dust vacuumed from nearly 7000 bedrooms were measured by using immunoassays. Exposure levels were classified as increased based on percentile (75th/90th) cutoffs. We estimated the burden of exposure to multiple allergens and used multivariable logistic regression to identify independent predictors for each allergen and household allergen burden. RESULTS: Almost all participants (>99%) had at least 1 and 74.2% had 3 to 6 allergens detected. More than two thirds of participants (72.9%) had at least 1 allergen and 18.2% had 3 or more allergens exceeding increased levels. Although exposure variability showed significant racial/ethnic and regional differences, high exposure burden to multiple allergens was most consistently associated with the presence of pets and pests, living in mobile homes/trailers and older and rental homes, and living in nonmetropolitan areas. CONCLUSIONS: Exposure to multiple allergens is common. Despite highly variable exposures, bedroom allergen burden is strongly associated with the presence of pets and pests.


Subject(s)
Allergens/immunology , Environmental Exposure/prevention & control , Adolescent , Air Pollution, Indoor/prevention & control , Asthma/immunology , Child , Child, Preschool , Dust/immunology , Female , Housing , Humans , Hypersensitivity/immunology , Infant , Male , Nutrition Surveys/methods
5.
J Allergy Clin Immunol ; 140(4): 1130-1137.e5, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28238748

ABSTRACT

BACKGROUND: A Seasonal Asthma Exacerbation Predictive Index (saEPI) was previously reported based on 2 prior National Institute of Allergy and Infectious Diseases Inner City Asthma Consortium trials. OBJECTIVE: This study sought to validate the saEPI in a separate trial designed to prevent fall exacerbations with omalizumab therapy. METHODS: The saEPI and its components were analyzed to characterize those who had an asthma exacerbation during the Preventative Omalizumab or Step-Up Therapy for Fall Exacerbations (PROSE) study. We characterized those inner-city children with and without asthma exacerbations in the fall period treated with guidelines-based therapy (GBT) in the absence and presence of omalizumab. RESULTS: A higher saEPI was associated with an exacerbation in both the GBT alone (P < .001; area under the curve, 0.76) and the GBT + omalizumab group (P < .01; area under the curve, 0.65). In the GBT group, younger age at recruitment, higher total IgE, higher blood eosinophil percentage and number, and higher treatment step were associated with those who had an exacerbation compared with those who did not. In the GBT + omalizumab group, younger age at recruitment, increased eosinophil number, recent exacerbation, and higher treatment step were also associated with those who had an exacerbation. The saEPI was associated with a high negative predictive value in both groups. CONCLUSIONS: An exacerbation in children treated with GBT with or without omalizumab was associated with a higher saEPI along with higher markers of allergic inflammation, treatment step, and a recent exacerbation. Those that exacerbated on omalizumab had similar features with the exception of some markers of allergic sensitization, indicating a need to develop better markers to predict poor response to omalizumab therapy and alternative treatment strategies for children with these risk factors. The saEPI was able to reliably predict those children unlikely to have an asthma exacerbation in both groups.


Subject(s)
Anti-Allergic Agents/therapeutic use , Asthma/diagnosis , Omalizumab/therapeutic use , Severity of Illness Index , Urban Population , Animals , Asthma/epidemiology , Child , Disease Progression , Female , Humans , Male , Practice Guidelines as Topic , Predictive Value of Tests , Prognosis , Risk Factors , Seasons , Treatment Outcome , United States/epidemiology
6.
J Allergy Clin Immunol ; 140(4): 933-949, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28502823

ABSTRACT

Environmental exposures have been recognized as critical in the initiation and exacerbation of asthma, one of the most common chronic childhood diseases. The National Institute of Allergy and Infectious Diseases; National Institute of Environmental Health Sciences; National Heart, Lung, and Blood Institute; and Merck Childhood Asthma Network sponsored a joint workshop to discuss the current state of science with respect to the indoor environment and its effects on the development and morbidity of childhood asthma. The workshop included US and international experts with backgrounds in allergy/allergens, immunology, asthma, environmental health, environmental exposures and pollutants, epidemiology, public health, and bioinformatics. Workshop participants provided new insights into the biologic properties of indoor exposures, indoor exposure assessment, and exposure reduction techniques. This informed a primary focus of the workshop: to critically review trials and research relevant to the prevention or control of asthma through environmental intervention. The participants identified important limitations and gaps in scientific methodologies and knowledge and proposed and prioritized areas for future research. The group reviewed socioeconomic and structural challenges to changing environmental exposure and offered recommendations for creative study design to overcome these challenges in trials to improve asthma management. The recommendations of this workshop can serve as guidance for future research in the study of the indoor environment and on environmental interventions as they pertain to the prevention and management of asthma and airway allergies.


Subject(s)
Air Pollution, Indoor/adverse effects , Asthma/prevention & control , Drug Industry , National Heart, Lung, and Blood Institute (U.S.) , National Institute of Allergy and Infectious Diseases (U.S.) , National Institute of Environmental Health Sciences (U.S.) , Organizations, Nonprofit , Animals , Asthma/diagnosis , Asthma/epidemiology , Biomedical Research , Child , Consensus Development Conferences, NIH as Topic , Environmental Health , Fund Raising , Humans , United States
7.
Am J Public Health ; 106(7): 1235-42, 2016 07.
Article in English | MEDLINE | ID: mdl-27196662

ABSTRACT

OBJECTIVES: To review how disasters introduce unique challenges to conducting population-based research and community-based participatory research (CBPR). METHODS: From 2007-2009, we conducted the Head-off Environmental Asthma in Louisiana (HEAL) Study in the aftermath of Hurricane Katrina in a Gulf Coast community facing an unprecedented triple burden: Katrina's and other disasters' impact on the environment and health, historic health disparities, and persistent environmental health threats. RESULTS: The unique triple burden influenced every research component; still, most existing CBPR principles were applicable, even though full adherence was not always feasible and additional tailored principles govern postdisaster settings. CONCLUSIONS: Even in the most challenging postdisaster conditions, CBPR can be successfully designed, implemented, and disseminated while adhering to scientific rigor.


Subject(s)
Community-Based Participatory Research/organization & administration , Disasters , Research Design , Capacity Building/organization & administration , Communication , Cyclonic Storms , Environment , Female , Health Status , Humans , Interinstitutional Relations , Louisiana , Male , Socioeconomic Factors
8.
J Asthma ; 53(8): 825-34, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27049234

ABSTRACT

OBJECTIVE: To report implementation strategies and outcomes of an evidence-based asthma counseling intervention. The Head-off Environmental Asthma in Louisiana (HEAL) intervention integrated asthma counseling (AC) capacity and addressed challenges facing children with asthma in post-disaster New Orleans. METHODS: The HEAL intervention enrolled 182 children (4-12 years) with moderate-to-severe persistent asthma. Recruitment occurred from schools in the Greater New Orleans area for one year. Participants received home environmental assessments and tailored asthma counseling sessions during the study period based on the National Cooperative Inner City Asthma Study and the Inner City Asthma Study. Primary (i.e., asthma symptoms) and secondary outcomes (i.e., healthcare utilization) were captured. During the study, changes were made to meet the demands of a post-hurricane and resource-poor environment which included changes to staffing, training, AC tools, and AC sessions. RESULTS: After study changes were made, the AC visit rate increased by 92.3%. Significant improvements were observed across several adherence measures (e.g., running out of medications (p = 0.009), financial/insurance problems for appointments (p = 0.006), worried about medication side-effects (p = 0.01), felt medications did not work (p < 0.001)). Additionally, an increasing number of AC visits was modestly associated with a greater reduction in symptoms (test-for-trend p = 0.059). CONCLUSION: By adapting to the needs of the study population and setting, investigators successfully implemented a counseling intervention that improved participant behaviors and clinical outcomes. The strategies for implementing the AC intervention may serve as a guide for managing asthma and other chronic conditions in resource-poor settings.


Subject(s)
Asthma , Patient Education as Topic , Asthma/drug therapy , Asthma/prevention & control , Child , Child, Preschool , Cities , Counseling , Evidence-Based Practice , Health Promotion , Health Services Accessibility , Humans , Louisiana , Medication Adherence , Poverty Areas , Urban Population
10.
J Allergy Clin Immunol ; 135(6): 1465-73.e5, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25794658

ABSTRACT

BACKGROUND: Asthma exacerbations remain common, even in children and adolescents, despite optimal medical management. Identification of host risk factors for exacerbations is incomplete, particularly for seasonal episodes. OBJECTIVE: We sought to define host risk factors for asthma exacerbations unique to their season of occurrence. METHODS: This is a retrospective analysis of patients aged 6 to 20 years who comprised the control groups of the Asthma Control Evaluation study and the Inner City Anti-IgE Therapy for Asthma study. Univariate and multivariate models were constructed to determine whether patients' demographic and historical factors, allergic sensitization, fraction of exhaled nitric oxide values, spirometric measurements, asthma control, and treatment requirements were associated with seasonal exacerbations. RESULTS: The analysis included 400 patients (54.5% male; 59.0% African American; median age, 13 years). Exacerbations occurred in 37.5% of participants over the periods of observation and were most common in the fall (28.8% of participants). In univariate analysis impaired pulmonary function was significantly associated with greater odds of exacerbations for all seasons, as was an exacerbation in the previous season for all seasons except spring. In multivariate analysis exacerbation in the previous season was the strongest predictor in fall and winter, whereas a higher requirement for inhaled corticosteroids was the strongest predictor in spring and summer. The multivariate models had the best predictive power for fall exacerbations (30.5% variance attributed). CONCLUSIONS: Among a large cohort of inner-city children with asthma, patients' risk factors for exacerbation vary by season. Thus information on individual patients might be beneficial in strategies to prevent these seasonal events.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , Anti-Asthmatic Agents/therapeutic use , Asthma/diagnosis , Asthma/drug therapy , Nitric Oxide/metabolism , Adolescent , Black or African American , Analysis of Variance , Asthma/ethnology , Asthma/physiopathology , Child , Disease Progression , Exhalation , Female , Forced Expiratory Volume , Humans , Immunoglobulin E/blood , Male , Prognosis , Randomized Controlled Trials as Topic , Retrospective Studies , Risk Factors , Seasons , White People , Young Adult
11.
J Allergy Clin Immunol ; 134(2): 350-9, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24522093

ABSTRACT

BACKGROUND: Allergic sensitization is an important risk factor for the development of atopic disease. The National Health and Nutrition Examination Survey (NHANES) 2005-2006 provides the most comprehensive information on IgE-mediated sensitization in the general US population. OBJECTIVE: We investigated clustering, sociodemographic, and regional patterns of allergic sensitization and examined risk factors associated with IgE-mediated sensitization. METHODS: Data for this cross-sectional analysis were obtained from NHANES 2005-2006. Participants aged 1 year or older (n = 9440) were tested for serum specific IgEs (sIgEs) to inhalant and food allergens; participants 6 years or older were tested for 19 sIgEs, and children aged 1 to 5 years were tested for 9 sIgEs. Serum samples were analyzed by using the ImmunoCAP System. Information on demographics and participants' characteristics was collected by means of questionnaire. RESULTS: Of the study population aged 6 years and older, 44.6% had detectable sIgEs, whereas 36.2% of children aged 1 to 5 years were sensitized to 1 or more allergens. Allergen-specific IgEs clustered into 7 groups that might have largely reflected biological cross-reactivity. Although sensitization to individual allergens and allergen types showed regional variation, the overall prevalence of sensitization did not differ across census regions, except in early childhood. In multivariate modeling young age, male sex, non-Hispanic black race/ethnicity, geographic location (census region), and reported pet avoidance measures were most consistently associated with IgE-mediated sensitization. CONCLUSIONS: The overall prevalence of allergic sensitization does not vary across US census regions, except in early life, although allergen-specific sensitization differs based on sociodemographic and regional factors. Biological cross-reactivity might be an important but not the sole contributor to the clustering of allergen-specific IgEs.


Subject(s)
Allergens/immunology , Food Hypersensitivity/epidemiology , Immunoglobulin E/blood , Respiratory Hypersensitivity/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Child , Child, Preschool , Cross Reactions , Cross-Sectional Studies , Female , Food Hypersensitivity/blood , Food Hypersensitivity/ethnology , Food Hypersensitivity/immunology , Humans , Infant , Male , Middle Aged , Nutrition Surveys , Prevalence , Racial Groups , Respiratory Hypersensitivity/blood , Respiratory Hypersensitivity/ethnology , Respiratory Hypersensitivity/immunology , United States/epidemiology
12.
N Engl J Med ; 364(11): 1005-15, 2011 Mar 17.
Article in English | MEDLINE | ID: mdl-21410369

ABSTRACT

BACKGROUND: Research has underscored the effects of exposure and sensitization to allergens on the severity of asthma in inner-city children. It has also revealed the limitations of environmental remediation and guidelines-based therapy in achieving greater disease control. METHODS: We enrolled inner-city children, adolescents, and young adults with persistent asthma in a randomized, double-blind, placebo-controlled, parallel-group trial at multiple centers to assess the effectiveness of omalizumab, as compared with placebo, when added to guidelines-based therapy. The trial was conducted for 60 weeks, and the primary outcome was symptoms of asthma. RESULTS: Among 419 participants who underwent randomization (at which point 73% had moderate or severe disease), omalizumab as compared with placebo significantly reduced the number of days with asthma symptoms, from 1.96 to 1.48 days per 2-week interval, a 24.5% decrease (P<0.001). Similarly, omalizumab significantly reduced the proportion of participants who had one or more exacerbations from 48.8 to 30.3% (P<0.001). Improvements occurred with omalizumab despite reductions in the use of inhaled glucocorticoids and long-acting beta-agonists. CONCLUSIONS: When added to a regimen of guidelines-based therapy for inner-city children, adolescents, and young adults, omalizumab further improved asthma control, nearly eliminated seasonal peaks in exacerbations, and reduced the need for other medications to control asthma. (Funded by the National Institute of Allergy and Infectious Diseases and Novartis; ClinicalTrials.gov number, NCT00377572.).


Subject(s)
Anti-Asthmatic Agents/therapeutic use , Antibodies, Anti-Idiotypic/therapeutic use , Antibodies, Monoclonal/therapeutic use , Asthma/drug therapy , Administration, Inhalation , Animals , Anti-Asthmatic Agents/adverse effects , Antibodies, Anti-Idiotypic/adverse effects , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Humanized , Child , Cockroaches/immunology , Double-Blind Method , Drug Therapy, Combination , Dust/analysis , Female , Glucocorticoids/administration & dosage , Glucocorticoids/therapeutic use , Humans , Immunoglobulin E/blood , Male , Omalizumab , Poverty Areas , Practice Guidelines as Topic , Seasons , Urban Population
14.
J Allergy Clin Immunol ; 131(1): 135-43.e1-12, 2013 Jan.
Article in English | MEDLINE | ID: mdl-23174658

ABSTRACT

BACKGROUND: Peanut allergy (PA) is rare in countries in which peanuts are introduced early into infants' diets. Learning Early About Peanut Allergy (LEAP) is an interventional study aiming to assess whether PA can be prevented by oral tolerance induction. OBJECTIVE: We sought to characterize a population screened for the risk of PA. METHODS: Subjects screened for the LEAP interventional trial comprise the LEAP screening study cohort. Infants were aged 4 to 10 months and passed a prescreening questionnaire. RESULTS: This analysis includes 834 infants (mean age, 7.8 months). They were split into the following: group I, patients with mild eczema and no egg allergy (n = 118); group II, patients with severe eczema, egg allergy, or both but 0-mm peanut skin prick test (SPT) wheal responses (n = 542); group III, patients with severe eczema, egg allergy, or both and 1- to 4-mm peanut wheal responses (n = 98); and group IV, patients with greater than 4-mm peanut wheal responses (n = 76). Unexpectedly, many (17%) in group II had peanut-specific IgE sensitization (≥ 0.35 kU/L); 56% of group III were similarly sensitized. In contrast, none of the patients in group I and 91% of those in group IV had peanut-specific IgE sensitization. Sensitization on skin testing to peanut (SPT response of 1-4 mm vs 0 mm) was associated with egg allergy and severe eczema (odds ratio [OR], 2.31 [95% CI, 1.39-3.86] and 2.47 [95% CI, 1.14-5.34], respectively). Similar associations were observed with specific IgE sensitization. Black race was associated with a significantly higher risk of peanut-specific IgE sensitization (OR, 5.30 [95% CI, 2.85-9.86]). Paradoxically, for a given specific IgE level, black race was protective against cutaneous sensitization (OR, 0.15 [95% CI, 0.04-0.61]). CONCLUSION: Egg allergy, severe eczema, or both appear to be useful criteria for identifying high-risk infants with an intermediate level of peanut sensitization for entry into a PA prevention study. The relationship between specific IgE level and SPT sensitization needs to be considered within the context of race.


Subject(s)
Peanut Hypersensitivity/epidemiology , Allergens/immunology , Arachis/immunology , Eczema/complications , Female , Humans , Immunoglobulin E/immunology , Infant , Male , Peanut Hypersensitivity/complications , Peanut Hypersensitivity/diagnosis , Prognosis , Risk , Skin Tests
15.
J Allergy Clin Immunol ; 129(3 Suppl): S124-35, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22386505

ABSTRACT

BACKGROUND: Respiratory symptoms are commonly used to assess the impact of patient-centered interventions. OBJECTIVE: At the request of National Institutes of Health (NIH) institutes and other federal agencies, an expert group was convened to propose which measurements of asthma symptoms should be used as a standardized measure in future clinical research studies. METHODS: Asthma symptom instruments were classified as daily diaries (prospectively recording symptoms between research visits) or retrospective questionnaires (completed at research visits). We conducted a systematic search in PubMed and a search for articles that cited key studies describing development of instruments. We classified outcome instruments as either core (required in future studies), supplemental (used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011. RESULTS: Four instruments (3 daily diaries, 1 for adults and 2 for children; and 1 retrospective questionnaire for adults) were identified. Minimal clinically important differences have not been established for these instruments, and validation studies were only conducted in a limited number of patient populations. Validity of existing instruments may not be generalizable across racial-ethnic or other subgroups. CONCLUSIONS: An evaluation of symptoms should be a core asthma outcome measure in clinical research. However, available instruments have limitations that preclude selection of a core instrument. The working group participants propose validation studies in diverse populations, comparisons of diaries versus retrospective questionnaires, and evaluations of symptom assessment alone versus composite scores of asthma control.


Subject(s)
Asthma/physiopathology , Outcome Assessment, Health Care/standards , Severity of Illness Index , Adult , Asthma/prevention & control , Asthma/therapy , Caregivers , Child , Child, Preschool , Humans , Medical Records , Surveys and Questionnaires , Treatment Outcome
16.
J Allergy Clin Immunol ; 129(3): 694-701, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22244599

ABSTRACT

BACKGROUND: Asthma severity is reflected in many aspects of the disease, including impairment and future risks, particularly for exacerbations. According to the Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma, however, to assess more comprehensively the severity of asthma the level of current treatment needed to maintain a level of control should be included. OBJECTIVE: Development and validation of a new instrument, the Composite Asthma Severity Index (CASI), which can quantify disease severity by taking into account impairment, risk, and the amount of medication needed to maintain control. At present, there is no instrument available to measure and assess the multidimensional nature of asthma. METHODS: Twenty-six established asthma investigators, who are part of the National Institutes of Health-supported Inner City Asthma Consortium, participated in a modified Delphi consensus process to identify and weight the dimensions of asthma. Factor analysis was performed to identify independent domains of asthma by using the Asthma Control Evaluation trial. CASI was validated by using the Inner City Anti-IgE Therapy for Asthma trial. RESULTS: CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. At Asthma Control Evaluation trial enrollment, CASI ranged from 0 to 17, with a mean of 6.2. CASI was stable, with minimal change in variance after 1 year of treatment. In external validation, CASI detected a 32% larger improvement than did symptoms alone. CONCLUSION: CASI retained its discriminatory ability even with low levels of symptoms reported after months of guidelines-directed care. Thus, CASI has the ability to determine the level of asthma severity and provide a composite clinical characterization of asthma.


Subject(s)
Asthma/diagnosis , Severity of Illness Index , Urban Population , Adolescent , Adult , Albuterol/therapeutic use , Algorithms , Asthma/drug therapy , Asthma/physiopathology , Disease Progression , Drug Utilization , Female , Follow-Up Studies , Humans , Male , Practice Guidelines as Topic , Recurrence , Respiratory Function Tests , Risk , Treatment Outcome
17.
J Allergy Clin Immunol ; 127(1): 130-7, 137.e1-3, 2011 Jan.
Article in English | MEDLINE | ID: mdl-21145578

ABSTRACT

BACKGROUND: Asthma was the most common comorbidity of patients hospitalized with 2009 H1N1 influenza. OBJECTIVE: We sought to assess the immunogenicity and safety of an unadjuvanted, inactivated 2009 H1N1 vaccine in patients with severe versus mild-to-moderate asthma. METHODS: We conducted an open-label study involving 390 participants (age, 12-79 years) enrolled in October-November 2009. Severe asthma was defined as need for 880 µg/d or more of inhaled fluticasone equivalent, systemic corticosteroids, or both. Within each severity group, participants were randomized to receive intramuscularly 15 or 30 µg of 2009 H1N1 vaccine twice 21 days apart. Immunogenicity end points were seroprotection (hemagglutination inhibition assay titer ≥40) and seroconversion (4-fold or greater titer increase). Safety was assessed through local and systemic reactogenicity, asthma exacerbations, and pulmonary function. RESULTS: In patients with mild-to-moderate asthma (n = 217), the 2009 H1N1 vaccine provided equal seroprotection 21 days after the first immunization at the 15-µg (90.6%; 95% CI, 83.5% to 95.4%) and 30-µg (95.3%; 95% CI, 89.4% to 98.5%) doses. In patients with severe asthma (n = 173), seroprotection 21 days after the first immunization was 77.9% (95% CI, 67.7% to 86.1%) and 94.1% (95% CI, 86.8% to 98.1%) at the 15- and 30-µg doses, respectively (P = .004). The second vaccination did not provide further increases in seroprotection. Participants with severe asthma who are older than 60 years showed the lowest seroprotection (44.4% at day 21) with the 15-µg dose but had adequate seroprotection with 30 µg. The 2 dose groups did not differ in seroconversion rates. There were no safety concerns. CONCLUSION: Monovalent inactivated 2009 H1N1 pandemic influenza vaccine was safe and provided overall seroprotection as a surrogate of efficacy. In patients older than 60 years with severe asthma, a 30-µg dose might be more appropriate.


Subject(s)
Asthma/immunology , Influenza A Virus, H1N1 Subtype/immunology , Influenza Vaccines/administration & dosage , Influenza Vaccines/immunology , Influenza, Human/prevention & control , Adolescent , Adult , Aged , Asthma/epidemiology , Child , Comorbidity , Female , Humans , Influenza, Human/immunology , Male , Middle Aged , Vaccination , Young Adult
18.
J Allergy Clin Immunol ; 125(3): 521-6; quiz 527-8, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20226288

ABSTRACT

For children living in inner cities, asthma tends to be more frequent and severe. To characterize, understand, and treat children with asthma living in the inner city more effectively, the National Institute of Allergy and Infectious Diseases established an Inner-City Asthma Program in 1991. In addition, the revised National Asthma Education and Prevention Program Expert Panel 3 report was introduced with new concepts for asthma management that are now centered on asthma control. The purpose of this review is to highlight features of the National Institute of Allergy and Infectious Diseases Inner-City Asthma Consortium Asthma Control Evaluation study that enhance our knowledge regarding the application of the asthma guidelines and to provide a summary of lessons learned from that important study. We recognized that asthma symptoms and exacerbations are theoretically linked to underlying inflammation of airways but are not direct indicators of inflammation. Based on the observations from the Asthma Control Evaluation study, we were impressed that a systematic guidelines-based approach improved asthma control significantly over the course of the 1-year treatment period.


Subject(s)
Anti-Asthmatic Agents/therapeutic use , Asthma/drug therapy , Practice Guidelines as Topic , Randomized Controlled Trials as Topic , Adolescent , Child , Humans , Medication Adherence , Multicenter Studies as Topic , National Institutes of Health (U.S.) , United States , Urban Population , Young Adult
19.
J Allergy Clin Immunol ; 125(3): 593-9, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20132971

ABSTRACT

BACKGROUND: Although sensitization to fungal allergens is prevalent in inner-city children with asthma, the relationship between fungal exposure and morbidity is poorly understood. OBJECTIVE: We examined relationships between fungal sensitization, exposure, and asthma morbidity in inner-city children. METHODS: Participants were 5 to 11 years old and enrolled in the Inner-City Asthma Study. This report includes the subset of children with at least 1 positive skin test (PST) response to a fungal allergen extract; for these children, indoor and outdoor airborne culturable fungi levels were measured at baseline and throughout the 2-year study. Asthma morbidity measures were collected prospectively. The primary outcome was symptom days per 2 weeks. RESULTS: At baseline, children with a PST response to a fungal allergen extract had significantly more symptom days compared with those without a PST response to any fungal allergen extract (6.3 vs 5.7 days per 2 weeks, P = .04). During the study, increases in total fungal exposure and indoor Penicillium species exposure were associated with increases in symptom days and asthma-related unscheduled visits. Indoor exposures to total fungi and to Penicillium species were associated with significant increases in unscheduled visits, even after controlling for outdoor fungal levels. Adverse effects associated with exposure to a specific fungus were stronger among children with PST responses to that fungal allergen extract compared with those seen in children with negative skin test responses. CONCLUSION: Outdoor fungal exposure is primarily associated with increased asthma symptoms and increased risk of exacerbations in this population.


Subject(s)
Air Pollution, Indoor/adverse effects , Allergens/immunology , Asthma/epidemiology , Environmental Exposure/adverse effects , Spores, Fungal/immunology , Asthma/etiology , Asthma/immunology , Child , Child, Preschool , Female , Fungi/immunology , Humans , Male , Morbidity , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Urban Health , Urban Population
20.
J Allergy Clin Immunol ; 125(3): 584-92, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20226295

ABSTRACT

BACKGROUND: There is an association between adiposity and asthma prevalence, but the relationship to asthma control is unclear. OBJECTIVES: We sought to understand the relationships among adiposity, sex, and asthma control in inner-city adolescents with asthma. METHODS: We prospectively followed 368 adolescents with moderate-to-severe asthma (ages 12-20 years) living in 10 urban areas for 1 year. Asthma symptoms and exacerbations were recorded, and pulmonary function and exhaled nitric oxide levels were measured every 6 weeks. Adiposity measures (body mass index [BMI] and dual-energy X-ray absorptiometric scans) were made, and blood was collected for measurement of allergy markers, adiponectin, leptin, TNF-alpha, IL-6, and C-reactive protein levels. RESULTS: More than 60% of female subjects and 50% of male subjects were above the 85th percentile of BMI for age. Higher BMI was associated with more symptom days (R = 0.18, P = .02) and exacerbations (R = 0.18, P = .06) among female subjects only. Adiponectin was inversely related to asthma symptoms (R = -0.18, P < .05) and exacerbations (R = -0.20, P < .05) and positively with FEV(1)/forced vital capacity ratio (R = 0.15, P < .05) in male subjects only independent of body size. There was no relationship between adiposity or adipokines and total IgE levels, blood eosinophil counts, and exhaled nitric oxide levels. Dual-energy X-ray absorptiometry provided little additional value in relating adiposity to asthma outcome in this population of adolescents. CONCLUSION: Adiposity is associated with poorer asthma control in female subjects. Adiponectin is associated with improved asthma control in male subjects.


Subject(s)
Adipokines/blood , Adiposity/physiology , Asthma/blood , Asthma/complications , Adolescent , Anti-Asthmatic Agents/therapeutic use , Asthma/drug therapy , Body Mass Index , Child , Enzyme-Linked Immunosorbent Assay , Female , Humans , Male , Obesity/blood , Obesity/complications , Practice Guidelines as Topic , Randomized Controlled Trials as Topic , Respiratory Function Tests , Urban Population , Young Adult
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