Clinical Asthma Control Research Articles

Control of airway inflammation maintained at a lower steroid dose with 100/50 μg of fluticasone propionate/salmeterol

Inhaled corticosteroids (ICSs) have been shown to reverse epithelial damage and decrease lamina reticularis thickness in patients with asthma. This study investigated whether clinical asthma control and airway inflammation could be maintained after switching therapy from medium-dose fluticasone propionate (FP) to low-dose FP administered with the long-acting beta2-agonist (LABA) salmeterol. Eighty-eight subjects (age, > or =18 years) who, during open-label screening, demonstrated improved asthma control after an increase from 100 microg of FP twice daily to 250 microg of FP twice daily were randomized to receive 100/50 microg of FP/salmeterol through a Diskus inhaler (GlaxoSmithKline, Research Triangle Park, NC) twice daily or continue 250 microg of FP twice daily through a Diskus inhaler for 24 weeks. Clinical outcomes were monitored, and bronchial biopsy specimens and bronchoalveolar lavage fluid were obtained before and after 24 weeks of treatment. There were no significant differences between treatments with respect to eosinophils in the bronchial mucosa and bronchoalveolar lavage fluid; mucosal mast cells, neutrophils, or CD3+, CD4+, CD8+, or CD25+ T lymphocytes; or concentration of mediators (GM-CSF, IL-8, and eosinophil cationic protein). The 2 treatments were not different with respect to lamina reticularis thickness. Consistent with the airway inflammatory measures, clinical and physiologic measures of asthma control were also similar. This study demonstrates that control of asthma and airway inflammation is maintained over the 24-week treatment period when patients requiring a medium-dose ICS are switched to a lower-dose ICS with a LABA. A lower-dose ICS with a LABA is effective in controlling inflammation and providing clinical asthma control, confirming current guideline recommendations.

Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma

Outcome data are needed to base recommendations for controller asthma medication use in school-aged children. We sought to determine intraindividual and interindividual response profiles and predictors of response to an inhaled corticosteroid (ICS) and a leukotriene receptor antagonist (LTRA). An ICS, fluticasone propionate (100 mug twice daily), and an LTRA, montelukast (5-10 mg nightly, age dependent), were administered to children ages 6 to 17 years with mild-to-moderate persistent asthma using only as-needed bronchodilators in a multicenter, double-masked, 2-sequence, 16-week crossover trial. Clinical, pulmonary, and inflammatory responses to these controllers were evaluated. Improvements in most clinical asthma control measures occurred with both controllers. However, clinical outcomes (asthma control days [ACDs], the validated Asthma Control Questionnaire, and albuterol use), pulmonary responses (FEV(1)/forced vital capacity, peak expiratory flow variability, morning peak expiratory flow, and measures of impedance), and inflammatory biomarkers (exhaled nitric oxide [eNO]) improved significantly more with fluticasone than with montelukast treatment. eNO was both a predictor of ACDs (P = .011) and a response indicator (P = .003) in discriminating the difference in ACD response between fluticasone and montelukast. The more favorable clinical, pulmonary, and inflammatory responses to an ICS than to an LTRA provide pediatric-based group evidence to support ICSs as the preferred first-line therapy for mild-to-moderate persistent asthma in children. eNO, as a predictor of response, might help to identify individual children not receiving controller medication who achieve a greater improvement in ACDs with an ICS compared with an LTRA.

Effect of Treating Allergic Rhinitis With Corticosteroids in Patients With Mild-to-Moderate Persistent Asthma

Rhinitis and asthma are considered to be synchronic or sequential forms of the same allergic syndrome. Treating the inflammation associated with allergic rhinitis influences the control of asthma. However, few studies have investigated the effect of treating perennial rhinitis on persistent asthma and vice versa. We determined the effects of inhaled or topical nasal beclomethasone dipropionate (BDP) administered separately or in combination on the control of asthma and bronchial hyperresponsiveness (BHR) in patients with the rhinitis/asthma association. A double-blind, parallel, three-group study. Outpatient clinic of Pulmonary Division/Heart Institute (InCor) and the Division of General Internal Medicine, University of Sao Paulo Medical School, Sao Paulo, Brazil. Seventy-four patients with mild-to-moderate asthma and allergic rhinitis (median age, 25 years). Patients received nasal or inhaled BDP separately or in combination for 16 weeks after a 2-week placebo run-in period. Nasal and pulmonary symptoms, as well as pulmonary function and BHR, were compared among the three groups after 4 weeks and 16 weeks of treatment. Patients in all three groups demonstrated a progressive and significant decrease in nasal and pulmonary symptoms, which started after 4 weeks (p < 0.05) and continued through the end of treatment (p < 0.001). Clinical improvement was similar and parallel in the three groups. Asthma-related morbidity, evaluated by quantifying absence from work, emergency department visits, and nighttime awakenings, also decreased in the three groups (p < 0.05). Failure to consider treatment of rhinitis as essential to asthma management might impair clinical control of asthma. Furthermore, these data suggest that asthma and rhinitis in some patients can be controlled by the exclusive use of nasal medication.

The Breathmobile™Program: Structure, Implementation, and Evolution of a Large-Scale, Urban, Pediatric Asthma Disease Management Program

Despite more than a decade of education and research-oriented intervention programs, inner city children with asthma continue to engage in episodic "rescue" patterns of healthcare and experience a disproportionate level of morbidity. The aim of this study was to establish and evaluate a sustainable community-wide pediatric asthma disease management program designed to shift inner city children in Los Angeles from acute episodic care to regular preventive care in accordance with national standards. In 1995 the Southern California Chapter of the Asthma and Allergy Foundation of America (AAFA), the Los Angeles County Department of Health Services (LAC DHS), and the Los Angeles Unified School District (LAUSD) established an agreement to initiate and sustain the Breathmobile Program. This program includes automated case identification, mobile school-based clinics, and highly structured clinical encounters supported by an advanced information technology solution. Interdisciplinary teams of asthma care specialists provide regular and ongoing care to children at school and county clinic sites over a wide geographic area of urban Los Angeles. Each team operates in a specially equipped mobile clinic (Breathmobile), efficiently moving a structured healthcare process to school and county clinic sites with large numbers of children. Demographic, clinical, and participation data is tracked carefully in an electronic medical record system. Program operations, clinical oversight, and patient tracking are centralized at a care coordination center. Clinical operations and methods have been replicated in fixed specialty clinic sites at the Los Angeles County + University of Southern California Medical Center. Clinical and process measures are regularly evaluated to assure quality, plan iterative improvement, and support evidence-based care. Four Breathmobiles deliver ongoing care at more than 90 school sites. The program has engaged over five thousand patients and their families in a continuity care model that has demonstrated efficacy over usual episodic care. More than 90% of patients in all asthma severity categories achieved clinical control of asthma with significant reductions in inpatient (IP) and emergency department (ED) use. On February 14, 2002, the program became the first program in the United States to receive the award of disease-specific care certification by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Proper design and resource allocation can sustain a school-based community-wide pediatric asthma disease management program and shift a population of inner city children from acute episodic care to routine preventive care in accordance with national standards. An evidence-based approach to evaluating and maintaining quality, coupled with stratified care delivery, can assure the efficient use of safety net healthcare resources.

Body mass index and its effects on clinical control of asthma

Body mass index and its effects on clinical control of asthma

Utility of a single survey for case identification and prediction of asthma control in an inner city disease management (Breathmobile) program

RATIONALE: Assessment of asthma disease activity and clinical control depends on detailed subjective information. Underestimating (disease activity) and overestimating (clinical control) are associated with morbidity and health care costs. The aim of this study was to determine whether a case identification survey could also be used for ongoing disease management to predict disease activity and control.METHODS: The 7 question bilingual survey was offered to parents/patients presenting for care in a pediatric (age ≤18) asthma disease management program. Surveys were completed at 4713 baseline and follow-up visits of patients with asthma. At each visit, an allergist (survey blinded) determined disease activity and whether the patient met the goals of therapy (clinical control). A stepwise regression model was used to determine the construct of answers that offered the greatest validity in relation to the specialist's rating of disease activity and level of control.RESULTS: Answer patterns were found to reliably predict uncontrolled asthma (sensitivity 76%, specificity 75%). The most predictive factors were night time symptoms (p<.0001) and medication use (p=.003). Strong predictors for more severe asthma activity were school days missed (<.0001), reliever medication usage (p<.0001), nighttime symptoms (p<.0001), and daytime symptoms (p<.0001).CONCLUSIONS: Point of care survey answer patterns can identify patients with asthma, predict disease activity, and assess whether the goals of therapy have been achieved. RATIONALE: Assessment of asthma disease activity and clinical control depends on detailed subjective information. Underestimating (disease activity) and overestimating (clinical control) are associated with morbidity and health care costs. The aim of this study was to determine whether a case identification survey could also be used for ongoing disease management to predict disease activity and control. METHODS: The 7 question bilingual survey was offered to parents/patients presenting for care in a pediatric (age ≤18) asthma disease management program. Surveys were completed at 4713 baseline and follow-up visits of patients with asthma. At each visit, an allergist (survey blinded) determined disease activity and whether the patient met the goals of therapy (clinical control). A stepwise regression model was used to determine the construct of answers that offered the greatest validity in relation to the specialist's rating of disease activity and level of control. RESULTS: Answer patterns were found to reliably predict uncontrolled asthma (sensitivity 76%, specificity 75%). The most predictive factors were night time symptoms (p<.0001) and medication use (p=.003). Strong predictors for more severe asthma activity were school days missed (<.0001), reliever medication usage (p<.0001), nighttime symptoms (p<.0001), and daytime symptoms (p<.0001). CONCLUSIONS: Point of care survey answer patterns can identify patients with asthma, predict disease activity, and assess whether the goals of therapy have been achieved.

The impact of patient compliance on effective asthma management.

Low rates of patient compliance pose a major challenge to effective asthma management. Non-compliance depends on many factors, including the patient's own treatment goals, beliefs about therapy, social and economic factors, administration route, convenience of device, and concerns about side-effects. Poor patient compliance may also be due to a discrepancy between the goals of the clinician and those of the patient. Clinicians tend to focus on prevention of mortality and reduction of morbidity, whereas patients are usually concerned with health-related quality of life. Improvement in patient compliance requires better clinician-patient communication and an improved therapeutic alliance between professional and patient, emphasizing shared goals. With shared decision-making, both the clinician and the patient decide on the patient's management plan. Together, they negotiate a plan that the patient is willing to follow and that works towards both sets of goals. A contractual agreement between patient and clinician may improve both clinical asthma control and patient health-related quality of life.

Asma e rinite alérgica como expressão de uma única doença: um paradigma em construção

To describe current ideas about the relation between upper and lower respiratory tract and to review the epidemiological, immunological, and pathological aspects that support the paradigm of united airways disease. Literature review using the Medline, MD Consult, HighWire, Medscape and Lilacs databases. We used allergic rhinitis and asthma as keywords, and searched articles published in the past 20 years. Epidemiological evidence includes prevalence of allergic rhinitis in asthmatic patients and vice-versa, results of cross-sectional studies, bronchial hyperresponsiveness in patients with allergic rhinitis, importance of genetic and environmental factors, and the age of onset of atopic disease. Morphological and physiological aspects show structural differences between the nasal and bronchial mucosa, and the mechanisms that could explain the effect of rhinitis on asthma. Immunological aspects including the participation of bone marrow in the production of inflammatory cells and allergic reactions after allergen challenge are the same in allergic rhinitis and asthma. Finally, the results of the therapy for allergic rhinitis in bronchial hyperresponsiveness and in clinical and functional control of asthma are also reported. Epidemiological evidence and immunological and pathological aspects suggest that there is a relation between allergic rhinitis and asthma. The paradigm of united airways disease suggests the implementation of an integrated therapeutic approach.

Patient preferences for autonomy in decision making in asthma management

BACKGROUNDLower patient preferences for autonomy in management decision making during asthma exacerbations have been associated with an increased risk for future hospital admissions. We sought to examine patient preferences for...

Asthma and sex hormones.

A chronic in ammatory state of the airways is considered the hallmark of asthma (1). However, the incidence, severity, and prognosis of asthma can be affected by a number of factors, including the patient's sex and age. The sex of the fetus seems to in uence the development of the respiratory apparatus. In fact, between weeks 28 and 40 of gestation, the lungs are in a more advanced state in females than in males (2), a fact which could explain, at least in part, the higher incidence of respiratory distress in male infants (3). Clinical observations and epidemiologic studies agree that childhood asthma is more frequent in boys than in girls (4). Moreover, in some children, usually boys, asthmatic symptoms that started in infancy disappear around puberty (5), while many girls have the disease only during adolescence (6). Age has been implicated in the severity of asthma. Asthma beginning during adulthood is generally more severe than childhood-onset asthma (7). Asthma that starts around the menopause or in old age is generally quite severe (5). According to two recent epidemiologic investigations, the patient's sex and age affect the hospitalization rate for asthma (8, 9), which is a marker of severity. In the ®rst study (a retrospective study of 33 269 patients), the admission rate of boys in the 0±10-year age group was almost twice that of girls. In the next decade, sex differences in the hospitalization rate were irrelevant, although there was a small, but signi®cant prevalence of females. At all ages above 20 years, hospital admission rates were higher in women than men, with a female/ male ratio ranging from 3:1 in subjects aged 20±50 years to 2.5:1 in those over 50 years of age (8). Similar data were reported by Elliasson (9). Both studies found a relationship between the age and sex of the patient and the severity of the asthma attack as indicated by duration of hospitalization. In fact, the duration of hospitalization increased with age in both sexes; moreover, hospital stays were longer in women over 30 years of age than in men of the same age (8, 9). Abbreviations. FSH: follicle-stimulating hormone; LH: luteinizing hormone; NK cell: natural killer cell; IL-1, -4, -5, -6: interleukin-1, -4, -5, -6; TGF-b: tumor growth factor-beta; PEFR: peak expiratory ow rate. Allergy 2001: 56: 13±20 Printed in UK. All rights reserved Copyright # Munksgaard 2001

Health-Related Quality of Life in Asthma

One aim of caring for adults and children with asthma should be the identification and treatment of the functional impairments that are troublesome to these patients in their daily lives. Studies have shown that correlations between measures of clinical asthma severity and control and health-related quality of life (HRQL) impairment are only weak to moderate. Therefore, HRQL must be measured directly. In recent years, HRQL questionnaires have been developed and validated to measure the functional (physical, social, emotional, and occupational) impairments that are important to both adults and children with asthma. Most questionnaires are now available in a range of languages. More recently, methods have been developed for the clinical interpretation on HRQL data. Assessment of asthma-specific HRQL can be included in both clinical trials and clinical practice, in conjunction with the conventional measures of airway function, to provide a complete picture of patients' health status.

Inhaled corticosteroids and growth - a review

OBJECTIVE: The aim of this review was to evaluate the medical literature in the last 10 years regarding the impact of the use of ICS on children and adolescents growth.METHODS: literature review.RESULTS: The use of ICS in childhood asthma in dosages appropriate to its severity does not seem to impair the adult height.CONCLUSIONS: The use of ICS in childhood asthma does not seem to impair growth. However, it is prudent to use the lowest possible dose necessary to achieve a good clinical control of asthma, as well as to monitor the growth of any child/adolescent receiving ICS.

Clinical effects of allergen avoidance.

The costs of asthma care are increasing. A successful, simple and widely applicable environmental intervention could have major benefits. Although all trials of bed coverings suggest they are clinically effective, the impact of their widespread use by asthmatics has not been determined in a public health context. In 1992, the British Society of Allergy and Clinical Immunology Working Group reviewed all the published data and, agreed on the inadequancy of avoidance trials and the need for a large-scale study on mite-allergen avoidance (97). More recently, the Third International Workshop on Indoor Allergens and Asthma stated: “There is an urgent need to develop adequately-powered, randomised, controlled studies to investigate the potential benefits of low-allergen domestic environments in patients with allergic disease. Such studies need to address compliance, cost effectiveness, be of adequate length (e.g., 12 months), and be tailored for different socio-economic groups and age groups” (98). The 1997 revision of the British Thoracic Society Asthma Guidelines states: “Support for house dust mite avoidance measures reflects a change to the 1993 Guidelines, but further research into methodology and duration of action of these measures is needed” (99). There remains an urgent need to develop a large-scale trial of the widespread applicability of miteallergen avoidance and the effect on patient symptoms, exacerbation rate, use of medication, and overall health costs. One such study on the effect of mite-allergen avoidance by the use of allergen-impermeable bedding on asthma control in adults is currently being carried out in the United Kingdom (100). This is a randomized, parallel-group, double-blind, placebo-controlled trial, with 2000 patients entering the run-in period and 1800 being randomized. During the first 6 mo of the trial (phase A) patients will take their usual inhaled steroid therapy, and during the next 6 mo (Phase B, mo 6\2-12) patients will make a controlled reduction of inhaled steroids. The results of this study will show conclusively whether a simple intervention designed to reduce domestic mite-allergen exposure can improvethe clinical control of asthma, which subgroups of patients benefit, and whether a reduction in regular inhaled steroid use can be achieved in primary-care patients.

Health-related quality of life in asthma.

One aim of caring for adults and children with asthma should be the identification and treatment of the functional impairments that are troublesome to these patients in their daily lives. Studies have shown that correlations between measures of clinical asthma severity and control and health-related quality of life (HRQL) impairment are only weak to moderate. Therefore, HRQL must be measured directly. In recent years, HRQL questionnaires have been developed and validated to measure the functional (physical, social, emotional, and occupational) impairments that are important to both adults and children with asthma. Most questionnaires are now available in a range of languages. More recently, methods have been developed for the clinical interpretation on HRQL data. Assessment of asthma-specific HRQL can be included in both clinical trials and clinical practice, in conjunction with the conventional measures of airway function, to provide a complete picture of patients' health status.

Measuring quality of life in children with asthma.

The Paediatric Asthma Quality of Life Questionnaire contains 23 items that children with asthma have identified as troublesome in their daily lives. The aim was to evaluate the measurement properties of the questionnaire. The study design consisted of a 9 week single cohort study with assessments at 1, 5 and 9 weeks. Patients participating in the study were fifty-two children, 7-17 years of age, with a wide range of asthma severity. At each clinic visit, a trained interviewer administered the Paediatric Asthma Quality of Life Questionnaire, the Feeling Thermometer, a clinical asthma control questionnaire and measured spirometry. For 1 week before each clinic visit, patients recorded morning peak flow rates, medication use and symptoms in a diary. The Paediatric Asthma Quality of Life Questionnaire was able to detect quality of life changes in those patients who altered their health status either as a result of treatment or natural fluctuations in their asthma (p < 0.001) and to differentiate these patients from those who remained stable (p < 0.0001). It was reproducible in patients who were stable (ICC = 0.95), which also indicates the instrument's strength to discriminate between subjects of different impairment levels. The questionnaire showed good levels of both longitudinal and cross-sectional correlations with the conventional asthma indices and with general quality of life. The results were consistent across individual domains and different age strata. The Paediatric Asthma Quality of Life Questionnaire has good measurement properties and is valid both as an evaluative and a discriminative instrument. It captures aspects of asthma most important to the patient and adds additional information to conventional clinical outcomes.

Measuring Quality of Life in Asthma

The aim of this study was to evaluate the measurement properties of an Asthma Quality of Life Questionnaire. The study design was an 8-wk unblinded single cohort with assessments at 0, 4, and 8 wk. Thirty-nine adults with symptomatic asthma and a wide range of airway responsiveness and medication requirements were enrolled from previous studies and through notices in the local media. Those with inadequately controlled asthma were offered an inhaled steroid (budesonide). Asthma Quality of Life Questionnaire, spirometry, a clinical asthma control questionnaire, medication requirements, airway responsiveness to methacholine, the Sickness Impact Profile, and the Rand questionnaire were recorded at each visit. Patients kept daily diaries of peak flow rates and medications. The Asthma Quality of Life Questionnaire was able to detect changes in patients who responded to treatment or who had natural fluctuations in their asthma (p < 0.001) and to differentiate these patients from those who remained stable (p < 0.001). The Questionnaire was reproducible in patients who were stable (intraclass correlation coefficient = 0.92). There were significant longitudinal and cross-sectional correlations between asthma quality of life and other measures of both clinical asthma and generic quality of life. We conclude that the Asthma Quality of Life Questionnaire has good measurement properties and that it is valid as both an evaluative and a discriminative instrument. It measures the component of asthma most important to patients, and it should be considered for inclusion in all asthma studies.