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1.  Predictors of Remitting, Periodic, and Persistent Childhood Asthma 
The course of mild to moderate persistent asthma in children is not clearly established.
To determine the rate and predictors for remitting, periodic, and persistent asthma in adolescence.
The Childhood Asthma Management Program (CAMP) was a 4.3-year randomized, double-masked, multicenter trial in children with mild to moderate persistent asthma that compared continuous therapy with either budesonide or nedocromil, each to placebo, followed by 4 years observational follow-up period. Asthma activity during the observation period included remitting (no asthma activity in the last year), persistent (asthma activity in every quarter), and periodic asthma (neither remitting nor persistent).
Asthma was identified as remitting in 6%, periodic in 39%, and persistent in 55% of the 909 participants, with no effect noted from earlier anti-inflammatory treatment during the CAMP trial. Within all three asthma activity categories, improvements in airway hyperresponsiveness, eosinophilia, and asthma morbidity were observed over time. Features at entry into CAMP associated with remitting vs. persistent asthma were lack of allergen sensitization and exposure to indoor allergens [OR=3.23, p<0.001], milder asthma [OR=2.01, p=0.03], older age [OR=1.23, p=0.01], less airway hyperresponsiveness (higher log methacholine FEV1 PC20 [OR=1.39, p=0.03]), higher pre-bronchodilator FEV1 % predicted [OR=1.05, p=0.02], and lower FVC % predicted [OR=0.96, p=0.04].
Remission of asthma in adolescence is infrequent and not impacted by 4 years of anti-inflammatory controller therapy. Factors such as sensitization and exposure, low lung function, and airway greater hyperresponsiveness decrease the likelihood of remitting asthma.
PMCID: PMC2844768  PMID: 20159245
Remission; Natural history; Persistent asthma
2.  Long-Term Budesonide or Nedocromil Treatment, Once Discontinued, Does Not Alter the Course of Mild to Moderate Asthma in Children and Adolescents 
The Journal of pediatrics  2009;154(5):682-687.
To determine whether long-term, continuous use of inhaled anti-inflammatory medications affects asthma outcomes in children with mild-moderate asthma after use is discontinued.
Study design
Of 1,041 participants in the Childhood Asthma Management Program randomized clinical trial, 941 (90%) were followed to determine whether 4.3 years of twice daily budesonide or nedocromil (each compared with placebo) affected subsequent asthma outcomes during a 4.8 year post-trial period in which treatment was managed by the participant's physician.
The groups treated continuously during the trial with either budesonide or nedocromil did not differ from placebo in lung function, control of asthma, or psychological status at the end of 4.8 years of post-trial follow-up; however, the decreased mean height in the budesonide group relative to the placebo group at the end of the trial (1.1 cm, P=0.005) remained statistically significant (0.9 cm, P=0.01) after an additional 4.8 years and was more pronounced in girls (1.7 cm; P=0.001) than boys (0.3 cm; P=0.49). Participants used inhaled corticosteroids during 30% of the post-trial period in all groups.
Clinically meaningful improvements in control of asthma and improvements in airway responsiveness achieved during continuous treatment with inhaled corticosteroids do not persist after continuous treatment is discontinued.
PMCID: PMC2942076  PMID: 19167726
3.  In Utero Smoke Exposure and Impaired Response to Inhaled Corticosteroids in Children with Asthma 
Few studies have examined the effects of in utero smoke exposure (IUS) on lung function in children with asthma, and there are no published data on the impact of IUS on treatment outcomes in asthmatic children.
To explore whether IUS exposure is associated with increased airway responsiveness among children with asthma, and whether IUS modifies the response to treatment with inhaled corticosteroids (ICS).
To assess the impact of parent-reported IUS exposure on airway responsiveness in childhood asthma we performed a repeated-measures analysis of methacholine PC20 data from the Childhood Asthma Management Program (CAMP), a four-year, multicenter, randomized double masked placebo controlled trial of 1041 children ages 5–12 comparing the long term efficacy of ICS with mast cell stabilizing agents or placebo.
Although improvement was seen in both groups, asthmatic children with IUS exposure had on average 26% less of an improvement in airway responsiveness over time compared to unexposed children (p=.01). Moreover, while children who were not exposed to IUS who received budesonide experienced substantial improvement in PC20 compared to untreated children (1.25 fold-increase, 95% CI 1.03, 1.50, p=.02) the beneficial effects of budesonide were attenuated among children with a history of IUS exposure (1.04 fold-increase, 95% CI 0.65, 1.68, p=.88).
IUS reduces age-related improvements in airway responsiveness among asthmatic children. Moreover, IUS appears to blunt the beneficial effects of ICS use on airways responsiveness. These results emphasize the importance of preventing this exposure through smoking cessation counseling efforts with pregnant women.
PMCID: PMC2937829  PMID: 20673983
asthma; in utero smoke exposure; airway responsiveness; inhaled corticosteroids
4.  Effects of ambient air pollution on symptoms of asthma in Seattle-area children enrolled in the CAMP study. 
Environmental Health Perspectives  2000;108(12):1209-1214.
We observed a panel of 133 children (5-13 years of age) with asthma residing in the greater Seattle, Washington, area for an average of 58 days (range 28-112 days) during screening for enrollment in the Childhood Asthma Management Program (CAMP) study. Daily self-reports of asthma symptoms were obtained from study diaries and compared with ambient air pollution levels in marginal repeated measures logistic regression models. We defined days with asthma symptoms as any day a child reported at least one mild asthma episode. All analyses were controlled for subject-specific variables [age, race, sex, baseline height, and FEV(1) PC(20) concentration (methacholine provocative concentration required to produce a 20% decrease in forced expiratory volume in 1 sec)] and potential time-dependent confounders (day of week, season, and temperature). Because of variable observation periods for participants, we estimated both between- and within-subject air pollutant effects. Our primary interest was in the within-subject effects: the effect of air pollutant excursions from typical levels in each child's observation period on the odds of asthma symptoms. In single-pollutant models, the population average estimates indicated a 30% [95% confidence interval (CI), 11-52%] increase for a 1-ppm increment in carbon monoxide lagged 1 day, an 18% (95% CI, 5-33%) increase for a 10-microg/m(3) increment in same-day particulate matter < 1.0 microm (PM(1.0)), and an 11% (95% CI, 3-20%) increase for a 10-microg/m(3) increment in particulate matter < 10 microm (PM(10)) lagged 1 day. Conditional on the previous day's asthma symptoms, we estimated 25% (95% CI, 10-42%), 14% (95% CI, 4-26%), and 10% (95% CI, 3-16%) increases in the odds of asthma symptoms associated with increases in CO, PM(1.0), and PM(10), respectively. We did not find any association between sulfur dioxide (SO(2)) and the odds of asthma symptoms. In multipollutant models, the separate pollutant effects were smaller. The overall effect of an increase in both CO and PM(1. 0) was a 31% (95% CI, 11-55%) increase in the odds of symptoms of asthma. We conclude that there is an association between change in short-term air pollution levels, as indexed by PM and CO, and the occurrence of asthma symptoms among children in Seattle. Although PM effects on asthma have been found in other studies, it is likely that CO is a marker for vehicle exhaust and other combustion by-products that aggravate asthma.
PMCID: PMC1240204  PMID: 11133403
5.  Health care utilization and medical costs for childhood asthma in Taiwan: using Taiwan National Health Insurance Research Database 
Asia Pacific Allergy  2012;2(3):167-171.
Asthma is an important health problem worldwide and the prevalence is increasing in most part of the world. The burden of this disease to governments, health-care systems, and patients and their families have been greater more than ever despite efforts advocated by Global Initiative for Asthma for total asthma controls. Using Taiwan National Health Insurance Research Database, in this review, the population-based prospective studies showed the costs and health care utilization of childhood asthma in Taiwan was 2 folds higher than non-asthmatic children, and the prescription patterns of anti-asthmatic medications among physician in different discipline were all far from satisfied. The appropriateness of combinational therapy of inhaled corticosteroids and long acting β-agonists for moderate to severe childhood asthma was only 62%. In a government-sponsored disease management program for asthmatic patients within national health insurance, though the total mean costs (26.5%) and outpatient costs (26.1%) increased, the mean emergency department visits and hospitalization rates were significantly reduced by 34.4% and 51.74%, respectively, compared to the previous year. Therefore, in the real-world situation, asthmatic patients as well as medical professions who take care of asthmatic children still have much space for their symptoms controls and knowledge improvement to reduce the burden of asthma. From the experience of care and management of childhood asthma in Taiwan may reveal same problems of childhood asthma care in the similar cultural and ecological environments of Asian pacific countries, and suggest government-sponsored program may also have significant impact aimed at improving the care of patients with asthma.
PMCID: PMC3406295  PMID: 22872818
Childhood asthma; Health care utilization; Disease management; National health insurance
6.  Prescribing patterns of asthma controller therapy for children in UK primary care: a cross-sectional observational study 
Asthma management guidelines recommend a stepwise approach to instituting and adjusting anti-inflammatory controller therapy for children with asthma. The objective of this retrospective observational study was to describe prescribing patterns of asthma controller therapies for children in a primary care setting.
Data from the UK General Practice Research Database were examined for children with recorded asthma or recurrent wheezing who, from September 2006 through February 2007, were ≤ 14 years old at the time of a first asthma controller prescription after ≥ 6 months without a controller prescription. We evaluated demographic characteristics, asthma duration, comorbidities, asthma-related health care resource use, and prescribed daily dose of controller medication. In addition, physicians for 635 randomly selected patients completed a survey retrospectively classifying asthma severity at the prescription date and describing therapy and health care utilization for 6 prior months.
We identified 10,004 children, 5942 (59.4%) of them boys, of mean (SD) age of 8.0 (3.8) years. Asthma controller prescriptions were for inhaled corticosteroid (ICS) monotherapy for 9059 (90.6%) children; ICS plus long-acting β2-agonist (LABA) for 698 (7.0%); leukotriene antagonist monotherapy for 91 (0.9%); ICS plus leukotriene antagonist for 55 (0.6%); and other therapy for 101 (1.0%), including 45 (0.45%) children who were prescribed LABA as monotherapy. High doses of ICS (> 400 μg) were prescribed for 44/2140 (2.1%) children < 5 years old and for 420/7452 (5.6%) children ≥ 5 years. Physicians reported asthma severity as intermittent for 346/635 (55%) patients and as mild, moderate, and severe persistent for 159 (25%), 71 (11%), and 11 (2%), respectively (severity data missing for 48 [8%]). The baseline characteristics and controller therapy prescriptions of the survey cohort were similar to those of the full cohort.
Physician classifications of asthma severity did not always correspond to guideline recommendations, as leukotriene receptor antagonists were rarely used and high-dose ICS or add-on LABA was prescribed even in intermittent and mild disease. In UK primary care, monotherapy with ICS is the most common controller therapy at all levels of asthma severity.
PMCID: PMC2882363  PMID: 20470409
7.  Factors associated with poor asthma control in children aged five to 13 years 
Most children with asthma should be able to achieve acceptable control. However, are there differences between those with acceptable and poor control, and if so, how can health care approaches be modified accordingly?
To examine the characteristics of elementary school children aged five to 13 years with acceptable and poor levels of asthma control.
The present cross-sectional study of children with asthma used five indicators of control, as outlined by the Canadian Asthma Consensus Report, to categorize acceptable and poor asthma control.
Of 153 children, 115 (75%) were rated as having poorly controlled asthma. Of those with poor control, 65 (64%) children were currently using inhaled corticosteroids, and 65% of those reported using inhaled corticosteroids daily versus as needed. Fifty-one per cent of the children with poorly controlled asthma had exposure to tobacco smoke, whereas 79% of the children with asthma under acceptable control were from households with no smokers (P=0.002). The poor control group also had significantly worse parental perceptions of the psychosocial impact of asthma on their child. No significant difference was found in the percentage of those who had written action plans in the poor control group (28%) compared with the acceptable control group (26%), and similar percentages in each group stated that they used the plans.
Despite the high use of inhaled corticosteroids, the majority of children had poorly controlled asthma. The poor control group had more exposure to tobacco smoke and a worse psychosocial impact due to asthma. Few children had past asthma education and action plans, suggesting that there is a need to improve access to and tools for education.
PMCID: PMC2539007  PMID: 16470250
Action plans; Asthma control; Asthma management; Childhood asthma; Environmental tobacco exposure; Inhaled corticosteroids
8.  Adherence to inhaled corticosteroids: An ancillary study of the Childhood Asthma Management Program clinical trial 
Information comparing subjective and objective measurements of adherence to study medications and the effects of adherence on treatment-related differences in asthma clinical trials are limited.
We sought to compare subjective and objective measurements of children’s adherence to inhaled corticosteroids or placebo and to determine whether adherence to study medications modified treatment-related differences in outcomes.
In an ancillary study conducted in 3 of 8 Childhood Asthma Management Program Clinical Centers, adherence was assessed by using self-reported and objective data in 5- to 12-year-old children with mild or moderate asthma who were randomly assigned to 200 μg of inhaled budesonide twice per day (n = 84) or placebo (n = 56) for 4 years. The κ statistic was used to evaluate agreement between self-reported adherence (daily diary cards) and objectively measured adherence (number of doses left in study inhalers). Multivariable analyses were used to determine whether adherence to study treatment modified treatment-related differences in outcomes.
Adherence of less than 80% was seen in 75% of 140 children when adherence was measured objectively but only in 6% of children when measured by means of self-report. There was poor agreement between objective and subjective measurements of adherence of at least 80% (κ = 0.00; 95% CI, −0.05 to 0.04); self-reported adherence over the 4-year period generally overestimated objectively measured adherence (93.6% vs 60.8%, P < .0001). There was little evidence to indicate that adherence modified treatment-related differences in outcomes.
Researchers should use objective rather than self-reported adherence data to identify clinical trial participants with low levels of adherence to study treatment.
PMCID: PMC3350797  PMID: 22104610
Asthma; adherence; compliance; children; lung growth; inhaled corticosteroids; budesonide; clinical trial
9.  276 A 4-Year Follow-up in Children With Moderate/Severe Asthma after Withdrawal 1 Year Omalizumab Treatment 
Asthma guidelines include omalizumab in the step up management in those patients with severe non-controlled asthma despite the use of the inhaled corticosteroids (ICS) at the highest dose recommended and/or oral corticosteroids (OCS) courses. This communication describes the 4 year follow up of children with moderate/severe allergic asthma treated for 1 year with add-on omalizumab after discontinuation.
7 children (6 to <12 years) with moderate/severe uncontrolled asthma following strict inclusion/exclusion criteria. The patients completed a 1 year treatment with omalizumab according to the DBPC CIGE025 clinical study protocol. Four years follow up after discontinuation of the study medication was performed. It included clinical assessment, different asthma-related outcomes and lung function in outpatient hospital office
All patients that received xolair during the study period achieved good asthma control and high dose ICS (mean dose fluticasone 500 mcg) were could be discontinued. Surprisingly, the 7 patients that received Xolair for one year were completely free of asthma symptoms during the first 3 years of follow up. They did not use any additional asthma medication. After the third year of follow up, only 2 out of 7 (28%) patients begun with persistent asthma symptoms and exacerbations. These patients have required rescue medication and then regular controller medication (budesonide 400 mcg). We could not identified any risk factor helping in predicting those who had symptoms relapsing. Lung function, number of exacerbation, number of hospitalization, eosinophilia, IgE levels or previous treatments with OCS
Most of these patients 5 out of 7 still remain asymptomatic 4 years after discontinuation Xolair without regular ICS treatment. They are still not using any controller medication only 2 patients had exacerbations and at present show persistent mild asthma controlled with medium ICS therapy. This follow up would generate the hypothesis that omalizumab could have a potential as a modifier of the natural history of asthma beyond the improvement of symptoms control in children with moderate/severe uncontrolled asthma. Further studies are needed to test this hypothesis.
PMCID: PMC3512580
10.  The Childhood Asthma Management Program (CAMP): Contributions to the Understanding of Therapy and the Natural History of Childhood Asthma 
Current respiratory care reports  2012;1(4):243-250.
The Childhood Asthma Management Program (CAMP) has been in continuous existence for almost two decades, which makes it the largest randomized, placebo-controlled clinical trial with extended follow-up for children with mild to moderate asthma. As such, its cumulative data from baseline, active treatment, and post-treatment have proved to be an invaluable resource for not only assessing the efficacy and safety of long-term inhaled corticosteroid therapy in childhood, but for discovery of many other aspects of childhood asthma, including genetics and biomarkers.
PMCID: PMC3546823  PMID: 23336093
Asthma; childhood; spirometry; airway hyperresponsiveness; inhaled corticosteroids; bronchodilators; bronchodilator response; allergy; pharmacogenomics; bone mineral density; vitamin D; linear growth; cataracts; hypothalamic–pituitary–adrenal axis; remission; progression; exacerbation; oral corticosteroids; nedocromil; forced expiratory volume in one second (FEV1); forced vital capacity (FVC); symptoms; health care utilization; phenotype; genetic polymorphism; eosinophils
11.  Canadian Pediatric Asthma Consensus Guidelines, 2003 (updated to December 2004): Introduction 
CMAJ: Canadian Medical Association Journal  2005;173(6 Suppl):S12-S14.
Although guidelines for the diagnosis and management of asthma have been published over the last 15 years, there has been little focus on issues relating to asthma in childhood. Since the last revision of the 1999 Canadian asthma consensus report, important new studies, particularly in children, have highlighted the need to incorporate this new information into asthma guidelines.
To review the literature on asthma published between January 2000 and June 2003 and to evaluate the influence of new evidence on the recommendations made in the Canadian Asthma Consensus Report, 1999 and its 2001 update with a major focus on pediatric issues.
Diagnosis of asthma in young children, prevention strategies, pharmacotherapy, inhalation devices, immunotherapy and asthma education were selected for review by small expert resource groups. In June 2003, the reviews were discussed at a meeting under the auspices of the Canadian Network For Asthma Care and the Canadian Thoracic Society. Data published up to December 2004 were subsequently reviewed by the individual expert resource groups.
This report evaluates early life prevention strategies and focuses on treatment of asthma in children. Emphasis is placed on the importance of an early diagnosis and prevention therapy, the benefits of additional therapy and the essential role of asthma education.
We generally support previous recommendations and focus on new issues, particularly those relevant to children and their families. This guide for asthma management is based on the best available published data and the opinion of health care professionals including asthma experts and educators.
PMCID: PMC1329946  PMID: 16157728
12.  2003 Canadian Asthma Consensus Guidelines Executive Summary 
Guidelines for the diagnosis and management of asthma have been published over the last 15 years; however, there has been little focus on issues relating to asthma in childhood. Since the last revision of the 1999 Canadian Asthma Consensus Report, important new studies, particularly in children, have highlighted the need to incorporate new information into the asthma guidelines. The objectives of this article are to review the literature on asthma published between January 2000 and June 2003 and to evaluate the influence of new evidence on the recommendations made in the 1999 Canadian Asthma Consensus Report and its 2001 update, with a major focus on pediatric issues.
The diagnosis of asthma in young children and prevention strategies, pharmacotherapy, inhalation devices, immunotherapy, and asthma education were selected for review by small expert resource groups. The reviews were discussed in June 2003 at a meeting under the auspices of the Canadian Network For Asthma Care and the Canadian Thoracic Society. Data published through December 2004 were subsequently reviewed by the individual expert resource groups.
This report evaluates early-life prevention strategies and focuses on treatment of asthma in children, emphasizing the importance of early diagnosis and preventive therapy, the benefits of additional therapy, and the essential role of asthma education.
We generally support previous recommendations and focus on new issues, particularly those relevant to children and their families. This document is a guide for asthma management based on the best available published data and the opinion of health care professionals, including asthma experts and educators.
PMCID: PMC3238210  PMID: 20529217
13.  The Effect of Long-term Corticosteroid Use on Bone Mineral Density in Children: A Prospective Longitudinal Assessment in the Childhood Asthma Management Program (CAMP) Study 
Pediatrics  2008;122(1):e53-e61.
Systemic corticosteroids are known to induce osteoporosis and increase the risk of fractures in adults and children. Inhaled corticosteroids have been shown to increase the risk of osteoporosis and fractures in adults at risk. However, long-term prospective studies in children to assess risks of multiple short courses of oral corticosteroids and chronic inhaled corticosteroids have not been done. Thus, we assessed the effects of multiple short courses of oral corticosteroids and long-term inhaled corticosteroids on bone mineral accretion over a period of years.
Patients and Methods
This was a cohort followup study for a median of 7 years of children with mild to moderate asthma initially randomized into the Childhood Asthma Management Program (CAMP) trial. Serial dual-energy x-ray absorptiometry (DEXA) scans of the lumbar spine for bone mineral density (BMD) were performed in all patients. Annual bone mineral accretion was calculated in 531 boys and 346 girls with asthma aged 5–12 years at baseline (84% of the initial cohort).
Oral corticosteroid bursts produced a dose-dependent reduction in bone mineral accretion (0.052, 0.049, and 0.046 gm/cm2/year, p=0.0002) and an increase in risk of osteopenia (10%, 14% and 21%, p=0.02) for 0, 1–4, and 5+ courses, respectively, in males but not females. Cumulative inhaled corticosteroid use was associated with a small decrease in bone mineral accretion in males (p=0.05) but not females, but no increased risk of osteopenia.
Multiple oral corticosteroid bursts over a period of years can produce a dose-dependent reduction in bone mineral accretion and increased risk of osteopenia in children with asthma. Inhaled corticosteroid use has the potential for reducing bone mineral accretion in male children progressing through puberty but this risk is likely to be outweighed by the ability to reduce the amount of oral corticosteroids used in these children.
PMCID: PMC2928657  PMID: 18595975
Cohort study; bone mineral density; corticosteroids; asthma; children; osteopenia
14.  Geographic variations of childhood asthma hospitalization and outpatient visits and proximity to ambient pollution sources at a U.S.-Canada border crossing 
Childhood asthma is a significant public health problem in the United States and evidence is accumulating regarding the contribution from traffic and ambient air pollution. This study is a companion piece of a related Buffalo asthma study in adults recently published in the July 2004 issue of American Journal of Public Health. This study focuses on children under 18 years of age diagnosed with asthma during a three-year period (2000–2002). In order to determine the effects of particulate air pollution on public health, we conducted an ecologic study of childhood asthma and point-source respirable particulate air pollution in patients diagnosed with asthma (n = 6,425). Patients diagnosed with gastroenteritis (n = 5,132) were used as controls.
Although the results of this study show spatial patterns similar to the ones observed in the adult study, a multiple-comparison test shows that EPA-designated focus sites located in Buffalo's east side are statistically (p < 0.008) more linked to childhood asthma than sites located elsewhere.
Findings of this study can be useful in geographic targeting and in the design of optimal and preventive measures.
PMCID: PMC1180465  PMID: 15943870
15.  Childhood Obesity and Asthma Control in the GALA II and SAGE II Studies 
Rationale: Obesity is associated with increased asthma morbidity, lower drug responsiveness to inhaled corticosteroids, and worse asthma control. However, most prior investigations on obesity and asthma control have not focused on pediatric populations, considered environmental exposures, or included minority children.
Objectives: To examine the association between body mass index categories and asthma control among boys and girls; and whether these associations are modified by age and race/ethnicity.
Methods: Children and adolescents ages 8–19 years (n = 2,174) with asthma were recruited from the Genes-environments and Admixture in Latino Americans (GALA II) Study and the Study of African Americans, Asthma, Genes, and Environments (SAGE II). Ordinal logistic regression was used to estimate odds ratios (OR) and their confidence intervals (95% CI) for worse asthma control.
Measurements and Main Results: In adjusted analyses, boys who were obese had a 33% greater chance of having worse asthma control than their normal-weight counterparts (OR, 1.33; 95% CI, 1.04–1.71). However, for girls this association varied with race and ethnicity (P interaction = 0.008). When compared with their normal-weight counterparts, obese African American girls (OR, 0.65; 95% CI, 0.41–1.05) were more likely to have better controlled asthma, whereas Mexican American girls had a 1.91 (95% CI, 1.12–3.28) greater odds of worse asthma control.
Conclusions: Worse asthma control is uniformly associated with increased body mass index in boys. Among girls, the direction of this association varied with race/ethnicity.
PMCID: PMC3678111  PMID: 23392439
obesity; asthma control; race and ethnicity; age; sex
16.  Predictors of poor response during asthma therapy differ with definition of outcome 
Pharmacogenomics  2009;10(8):1231-1242.
To evaluate phenotypic and genetic variables associated with a poor long-term response to inhaled corticosteroid therapy for asthma, based independently on lung function changes or asthma exacerbations.
Materials & methods
We tested 17 phenotypic variables and polymorphisms in FCER2 and CRHR1 in 311 children (aged 5–12 years) randomized to a 4-year course of inhaled corticosteroid during the Childhood Asthma Management Program (CAMP).
Predictors of recurrent asthma exacerbations are distinct from predictors of poor lung function response. A history of prior asthma exacerbations, younger age and a higher IgE level (p < 0.05) are associated with recurrent exacerbations. By contrast, lower bronchodilator response to albuterol and the minor alleles of RS242941 in CRHR1 and T2206C in FCER2 (p < 0.05) are associated with poor lung function response. Poor lung function response does not increase the risk of exacerbations and vice versa (p = 0.72).
Genetic and phenotypic predictors of a poor long-term response to inhaled corticosteroids differ markedly depending on definition of outcome (based on exacerbations vs lung function). These findings are important in comparing outcomes of clinical trials and in designing future pharmacogenetic studies.
PMCID: PMC2746392  PMID: 19663668
asthma; corticosteroid; exacerbation; lung function; pharmacogenetics
17.  Attitudes and actions of asthma patients on regular maintenance therapy: the INSPIRE study 
This study examined the attitudes and actions of 3415 physician-recruited adults aged ≥ 16 years with asthma in eleven countries who were prescribed regular maintenance therapy with inhaled corticosteroids or inhaled corticosteroids plus long-acting β2-agonists.
Structured interviews were conducted to assess medication use, asthma control, and patients' ability to recognise and self-manage worsening asthma.
Despite being prescribed regular maintenance therapy, 74% of patients used short-acting β2-agonists daily and 51% were classified by the Asthma Control Questionnaire as having uncontrolled asthma. Even patients with well-controlled asthma reported an average of 6 worsenings/year. The mean period from the onset to the peak symptoms of a worsening was 5.1 days. Although most patients recognised the early signs of worsenings, the most common response was to increase short-acting β2-agonist use; inhaled corticosteroids were increased to a lesser extent at the peak of a worsening.
Previous studies of this nature have also reported considerable patient morbidity, but in those studies approximately three-quarters of patients were not receiving regular maintenance therapy and not all had a physician-confirmed diagnosis of asthma. This study shows that patients with asthma receiving regular maintenance therapy still have high levels of inadequately controlled asthma. The study also shows that patients recognise deteriorating asthma control and adjust their medication during episodes of worsening. However, they often adjust treatment in an inappropriate manner, which represents a window of missed opportunity.
PMCID: PMC1483837  PMID: 16772035
18.  Brief interval telephone surveys of medication adherence and asthma symptoms in the Childhood Asthma Management Program Continuation Study 
To establish the relationship between adherence and symptom control in adolescents and young adults with asthma.
This was a telephone-interview study conducted as an ancillary project to the Childhood Asthma Management Program Continuation Study (CAMPCS).
The six monthly interviews were conducted from a single calling center in Denver, Colorado.
Included were 756 adolescent and young adult participants in CAMPCS, who upon entry into the original study were diagnosed to have mild to moderate asthma.
Outcome measures
Participants were queried about medication use and symptom control within each one-month interview window. Strategies adopted to improve self-report accuracy included use of repeat interviews, confidential reporting to staff unknown to the participants, and use of questions focused on recent behavior.
Only participants who were consistently on or off ICS medication for the entire six-month study interval were included. Three groups of patients were contrasted: those not on ICS medication (n=420), those on ICS with High Adherence (at least 75% of medication taken, n=90), and those on ICS with Low/Medium adherence (less than 75% taken, n=148). Participants in the Low/Medium adherence group reported on average less symptom control and more variability in wheezing, awakening at night, missed activities, and beta2 agonist use over the 6-month period, although most in this group perceived their asthma to be under good control.
Despite extensive patient education and support, diminished ICS adherence was frequent and undermined symptom control in this group of adolescents and young adults with mild to moderate asthma.
PMCID: PMC2949348  PMID: 18939726
19.  Clinical and Economic Outcomes Associated with Low-Dose Fluticasone Propionate Versus Montelukast in Children with Asthma Aged 4 to 11 Years 
Inhaled corticosteroids (ICS) are preferred first-line controller agents for adults and adolescents with asthma. There is limited effectiveness data comparing ICS to leukotriene receptor antagonists (LTRA) in children with asthma aged 4 to 11 years.
A retrospective, matched cohort study was conducted using medical and pharmacy claims data. Asthma patients (ICD-9, 493.xx) naïve to any asthma controller therapy, and having ≥1 dispensing of fluticasone propionate 44 mcg (FP44), an ICS, or montelukast any dose (MON), an LTRA, were identified. Drug cohorts were matched (1:2) using propensity scores. Outcomes during follow-up included asthma-related ED visits, composite measure of asthma-related ED/hospital visit, asthma-related costs per month, and monthly rescue medication use. Statistical differences between cohorts were evaluated using multivariate regression models.
The final matched sample included 6,636 patients (FP44=2,212; MON=4,424). During follow-up, the FP44 cohort had a 29% significantly lower risk of an asthma-related ED visit (Hazard ratio (95% CI) =0.71 (0.52, 0.96)) compared to the MON cohort. Monthly asthma-related costs were significantly reduced on average by 36% in the FP44 compared to the MON cohort ($48 vs $75, p<0.05). Use of short-acting beta-agonists per month were similar between cohorts but monthly adjusted number of oral corticosteroid prescriptions were significantly lower in the FP44 compared to the MON cohort (0.03 vs 0.04, p<0.001).
Initiation of FP44 versus MON in children with asthma aged 4 to 11 years is associated with a significant reduction in asthma-related ED visits, costs, and oral corticosteroid use.
PMCID: PMC3391652  PMID: 22787519
Asthma; pediatrics; inhaled corticosteroids; leukotriene; receptor antagonists; outcomes; costs.
20.  Outcomes After Periodic Use of Inhaled Corticosteroids in Children 
Many children with persistent asthma use inhaled corticosteroids on a periodic basis. Clinical trials in adults suggest that periodic use of inhaled corticosteroids may be effective for patients with mild persistent asthma. However, scant information exists on the clinical outcomes of children with asthma who are using inhaled corticosteroids on a periodic basis in real-world settings.
This prospective cohort study compared clinical outcomes during a 12-month follow-up period between children with persistent asthma whose parents believed that they were supposed to use inhaled steroids either (a) periodically or (b) daily year-round at the start of the period. The clinical outcomes studied were (1) asthma-related emergency department (ED) visits or hospitalizations, (2) uncontrolled asthma based on health care and medication use, and (3) outpatient visits for asthma.
Patients and methods
The study population included children with persistent asthma from two health plans whose parents reported that they were using inhaled corticosteroids during a baseline telephone interview. The interviews collected information on whether the children’s parents believed they were supposed to use inhaled corticosteroids on a periodic or daily basis, as well as baseline asthma symptom status, sociodemographic, and behavioral variables. We used computerized databases to identify clinical events for each child during the 12 months after their baseline interview. Uncontrolled asthma was defined as any asthma-related ED visit or hospitalization, two or more oral steroid prescription fills, or four or more beta-agonists canisters filled during the 12-month period. We compared these outcomes between the periodic versus daily users of inhaled corticosteroids using logistic regression analyses. We conducted both (1) a traditional logistic regression analysis in which we adjusted for selection bias by including covariates such as age, asthma physical status, sociodemographic and behavioral variables, and history of asthma-related health care use during the year before interview and (2) an analysis using propensity scores to more fully adjust for selection bias.
Of a total of 476 children in the study, 55% of parents believed their children were supposed to be using inhaled corticosteroids on a periodic basis and 45% believed their children were supposed to be using them daily year-round based on the baseline parent interview. At baseline, periodic inhaled corticosteroid users had less severe asthma than daily users based on several measures including better asthma physical status scores on the Children’s Health Survey for Asthma (mean 87 ± 16.0 vs. 81 ± 17.4, p = < 0.0001). During the year before the baseline interview, periodic users compared with daily users were less likely to have an ED visit or hospitalization (10% vs. 23%, p = 0.0001) and less likely to have had five or more albuterol prescription fills (13% vs. 31%, p < 0.0001). During the follow-up year, those who believed inhaled steroids were for periodic use were less likely than those who believed inhaled steroids were for daily use to have an ED visit or hospitalization for asthma (OR 0.36, 95% CI: 0.18–0.73), even after adjusting for baseline asthma status and other covariates. Similarly, those who believed inhaled steroids were for periodic use were less likely to have uncontrolled asthma, OR 0.38 (95% CI: 0.24–0.62). Analyses using propensity score adjustment yielded similar results to the logistic regression analyses.
Children whose parents believed they were supposed to use inhaled corticosteroids on a periodic basis had less severe asthma at baseline than those whose parents believed they were supposed to be using them daily. Periodic users were less likely than daily users to have adverse asthma outcomes during 1-year follow-up. This suggests that clinicians may be applying appropriate selection criteria by choosing patients with less severe asthma for periodic inhaled corticosteroid regimens.
PMCID: PMC4004094  PMID: 19544175
asthma; periodic inhaled corticosteroids; children
21.  Evaluation of a Peer-led Asthma Self-Management Program and Benefits of the Program for Adolescent Peer Leaders 
Respiratory care  2012;57(12):2082-2089.
Asthma is the leading chronic condition in adolescents. Nonetheless, research efforts to address adolescent asthma morbidity by applying a developmentally appropriate self-management intervention have been limited. Recently a peer-led asthma self-management program has been developed and implemented for adolescents. The purpose of the study was to assess the acceptability of a peer-led asthma program for adolescents based on participant feedback and to examine the program’s impact on asthma outcomes in peer leaders.
Adolescents with persistent asthma (N=91, 13–17 years) participated in a camp-based asthma program led by peer leaders (the intervention group) or healthcare professionals (the control group), and completed a set of program evaluation forms. Peer leaders (n=14, 16–20 years) completed study questionnaires measuring asthma knowledge, self-efficacy, asthma control and quality of life at baseline, immediately after camp, and 3-, 6- and 9-months post-camp.
The peer-led group reported more positive experience with the program than the adult-led group (p=.01, Cohen’s d=.53), particularly in its usefulness in dealing with asthma. Peer leaders were rated by participants highly on knowledge (98%), attitudes (93%–96%), personal skills (91%) and perceived similarities (80%–86%). Significant improvements were found in peer leaders’ knowledge (p<.001, η2 = .87), self-efficacy (p<.001, η2=.74), asthma control (p=.01, η2=.66) and quality of life in emotional functioning (p=.002, η2=.82) and activity (p=.003, η2=.62).
A peer-led asthma self-management program was successfully implemented and well received by adolescent learners. Asthma outcomes in peer leaders appear to have improved as a result of the program although caution should be exercised in determining clinical meaningfulness given the modest changes in mean scores.
PMCID: PMC3521097  PMID: 22710616
Asthma; Adolescents; Self-management; Peer-led program; Peer leaders
22.  Inflammatory phenotypes underlying uncontrolled childhood asthma despite inhaled corticosteroid treatment: rationale and design of the PACMAN2 study 
BMC Pediatrics  2013;13:94.
The diagnosis of childhood asthma covers a broad spectrum of pathological mechanisms that can lead to similarly presenting clinical symptoms, but may nonetheless require different treatment approaches. Distinct underlying inflammatory patterns are thought to influence responsiveness to standard asthma medication.
The purpose of the PACMAN2 study is to identify inflammatory phenotypes that can discriminate uncontrolled childhood asthma from controlled childhood asthma by measures in peripheral blood and exhaled air. PACMAN2 is a nested, case–control follow-up study to the ongoing pharmacy-based “Pharmacogenetics of Asthma medication in Children: Medication with Anti-inflammatory effects” (PACMAN) study. The original PACMAN cohort consists of children aged 4–12 years with reported use of asthma medication. The PACMAN2 study will be conducted within the larger PACMAN cohort, and will focus on detailed phenotyping of a subset of the PACMAN children. The selected participants will be invited to a follow-up visit in a clinical setting at least six months after their baseline visit based on their adherence to usage of inhaled corticosteroids, their asthma symptoms in the past year, and their age (≥ 8 years). During the follow-up visit, current and long-term asthma symptoms, medication use, environmental factors, medication adherence and levels of exhaled nitric oxide will be reassessed. The following measures will also be examined: pulmonary function, exhaled volatile organic compounds, as well as inflammatory markers in peripheral blood and blood plasma. Comparative analysis and cluster-analyses will be used to identify markers that differentiate children with uncontrolled asthma despite their use of inhaled corticosteroids (ICS) (cases) from children whose asthma is controlled by the use of ICS (controls).
Asthmatic children with distinct inflammatory phenotypes may respond differently to anti-inflammatory therapy. Therefore, by identifying inflammatory phenotypes in children with the PACMAN2 study, we may greatly impact future personalised treatment strategies, uncover new leads for therapeutic targets and improve the design of future clinical studies in the assessment of the efficacy of novel therapeutics.
PMCID: PMC3691827  PMID: 23768206
Asthma; Child; Phenotypes; Inflammation; Proteomics; Volatile organic compounds; Corticosteroids
23.  Adolescent decision-making about use of inhaled asthma controller medication: Results from focus groups with participants from a prior longitudinal study 
Adherence with inhaled controller medications for asthma is known to be highly variable with many patients taking fewer doses than recommended for consistent control of lung inflammation. Adherence also worsens as children become teenagers, although the exact causes are not well established.
To use focus group methodology to examine beliefs, feelings, and behaviors about inhaled asthma controller medication in adolescents and young adults who had previously participated in a longitudinal study of asthma treatment adherence and outcome in order to develop more effective management strategies.
Twenty-six subjects participated in 6 focus groups comprised of 3-5 young adults (age range 12-20 years). Verbatim transcripts of these groups were analyzed using the long-table method of content analysis to identify key themes raised by participants.
A variety of beliefs, feelings and behaviors influence the adolescent’s decision about how to use their asthma medication. Some of the adolescents understood the importance of daily medication and were committed to the treatment plan prescribed by their provider. Poorer adherence was the product of misinformation, incorrect assumptions about their asthma, and current life situations.
These results, by highlighting potential mechanisms underlying both better and worse adherence inform the development of strategies to improve adherence behavior in adolescents and young adults with asthma. Knowledge of the specific beliefs, feelings and behaviors that underlie adolescents’ use of inhaled asthma controller medication will help providers maximize treatment adherence in this notoriously difficult patient population.
PMCID: PMC3171210  PMID: 21854323
asthma; adherence; adolescence; beliefs; behaviors; controller; decision-making
24.  Inhaled corticosteroids and long-acting beta-agonists in adult asthma: a winning combination in all? 
In the recent years, considerable insight has been gained in to the optimal management of adult asthma. Most adult patients with asthma have mild intermittent and persistent disease, and it is acknowledged that many patients do not reach full control of all symptoms and signs of asthma. Those with mild persistent asthma are usually not well controlled without inhaled corticosteroids (ICS). Studies have provided firm evidence that these patients can be well controlled when receiving ICS, especially when disease is of recent onset. This treatment should be given on a daily basis at a low dose and when providing a good response should be maintained to prevent severe exacerbations and disease deterioration. Intermittent ICS treatment at the time of an exacerbation has also been suggested as a strategy for mild persistent asthma, but it is less effective than low-dose regular treatment for most outcomes. Adding a long-acting beta-agonist (LABA) to ICS appears to be unnecessary in most of these patients for optimising control of their asthma. Patients with moderate persistent asthma can be regarded as those who are not ideally controlled on low-dose ICS alone. The combination of an ICS and LABA is preferred in these patients, irrespective of the brand of medicine, and this combination is better than doubling or even quadrupling the dose of ICS to achieve better asthma control and reduce exacerbation risks. An ICS/LABA combination in a single inhaler represents a safe, effective and convenient treatment option for the management of patients with asthma unstable on inhaled steroids alone. Ideally, once asthma is under full control, the dose of inhaled steroids should be reduced, which is possible in many patients. The duration of treatment before initiating this dose reduction has, however, not been fully established. One of the combinations available to treat asthma (budesonide and formoterol) has also been assessed as both maintenance and rescue therapy with a further reduction in the risk for a severe exacerbation. Clinical effectiveness in the real world now has to be established, since this approach likely improves compliance with regular maintenance therapy.
PMCID: PMC2493602  PMID: 18500509
Asthma; Beta-2-agonist; Inhaled corticosteroids; Hyperresponsiveness
25.  Factors influencing asthma control: results of a real-life prospective observational asthma inhaler treatment (ASIT) study 
Despite the availability of new pharmacological options and novel combinations of existing drug therapies, the rate of suboptimal asthma control is still high. Therefore, early identification of the clinical and behavioral factors responsible for poor asthma control, and interventions during routine outpatient visits to improve asthma trigger management, are strongly recommended. This study was designed to evaluate the profiles of asthmatic patients and their inhaler treatment devices in relation to asthma control in Turkey.
A total of 572 patients with persistent asthma (mean [standard deviation] age: 42.7 [12.1] years; 76% female) were included in this prospective observational study. A baseline visit (0 month, visit 1) and three follow-up visits (1, 3 and 6 months after enrolment) were conducted to collect data on demographics, past medical and asthma history, and inhaler device use.
Asthma control was identified in 61.5% of patients at visit 1 and increased to 87.3% at visit 4 (P < 0.001), regardless of sociodemographics, asthma duration, body mass index or smoking status. The presence of asthma-related comorbidity had a significantly negative effect on asthma control (P = 0.004). A significant decrease was determined, in the rate of uncontrolled asthma, upon follow-up among patients who were using a variety of fixed dose combination inhalers (P < 0.001 for each). Logistic regression analysis was used to show that the presence of asthma-related comorbidity (odds ratio [OR], 0.602; 95% confidence interval [CI], 0.419; 0.863, P = 0.006) and active smoking (OR, 0.522; 95% CI, 0.330; 0.825, P = 0.005) were significant predictors of asthma control.
Our findings indicate that, despite ongoing treatment, asthma control rate was 61.5% at visit 1 in adult outpatients with persistent asthma. However, by the final follow-up 6 months later, this had increased to 87.3%, independent of sociodemographic and clinical characteristics. Poor asthma control was associated with asthma-related comorbid diseases, while the efficacy of fixed dose combinations was evident in the achievement of asthma control.
PMCID: PMC3702275  PMID: 23843695
persistent asthma; patient profile; asthma control; inhaler treatment; adults; Turkey

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