Disease control in asthmatic children seen in private practice in Switzerland

BACKGROUND: Asthma is the most common chronic childhood disease in Switzerland with a prevalence of 10%. Asthma has a high economic burden accounting for high medical costs. Assessment of disease control is likely to be of help in the implementation of strategies to improve asthma. Therefore, we aimed to evaluate asthma control and therapy regimens among children in private practice. METHODS: We assessed asthma control as well as therapy regimens in 575 asthmatic children in an experience programme in Switzerland by using an abbreviated questionnaire based on the asthma control questionnaire and the child health questionnaire on Visit 1 and Visit 2. RESULTS: Good asthma control at Visit 1 was only present in 25.7% of asthmatic children. Occasional asthma symptoms, limitation of physical activity, nocturnal awakening and anxiety of the parent was present in 80.5%, 41.2%, 46.8% and 57% of the children, respectively. After adjustment of therapy regimens at Visit 1, mainly by adding a leukotriene receptor antagonist, asthma control was reported to be much better in 53.4% of the children at Visit 2. CONCLUSIONS: As asthma control is inadequately achieved within a major portion of asthmatic children, it is imperative to find measures to improve asthma control and hence, to reduce the burden of disease.     

Asthma control in Switzerland: a general practitioner based survey

ABSTRACT

Background: Achievement of optimal asthma control is the goal of the Global Initiative for Asthma (GINA) guidelines.

Methods: In a survey involving 281 physicians, asthma control was assessed using the Juniper asthma control questionnaire (ACQ); physicians were also asked to judge patients’ asthma control subjectively.

Results: In total, 2127 patients were included. Follow-up was available in 1893 (89%) patients (885 females). The mean time between visits was 62 ± 29.3 days; mean age was 45 years (± 19 years) and 30% were smokers. Well-controlled asthma was found in 298 patients (16%). Smokers were less likely to have well-controlled asthma (smokers 12% vs. non-smokers 18%). Physicians assessed asthma control to be good in 292 patients (15%), sufficient in 504 (27%), insufficient in 954 (50%) and poor in 137 (7%) patients. Of the 292 patients assessed by their physicians as ‘good asthma control’, only 142 (49%) were confirmed as ‘well-controlled’ by the ACQ. At the first visit, 1308 (69%) patients were pre-treated with any inhaled corticosteroids (ICS). Pre-treatment with leukotriene receptor antagonists (LTRAs) was reported in 127 patients (7%). Add-on therapy with the LTRA montelukast was the most frequent treatment adjustment at the first visit. Out of 1893 patients who had a follow-up visit, 298 (16%) were well controlled at the first visit and 1170 (62%) at the follow-up visit.

Conclusion: Asthma control is insufficient in the majority of patients. Improvement of asthma control can be achieved by using objective measures such as the ACQ in regular clinical practice and adapting therapy.     

Efficacy of add-on montelukast in patients with non-controlled asthma: a Belgian open-label study*

ABSTRACT

Objective: To evaluate the efficacy of add-on montelukast on asthma control and allergic rhinitis symptoms in asthmatic patients still symptomatic with chronic treatment with inhaled corticosteroid and long-acting β₂ agonist (ICS/LABA), irrespective of the dose.

Research design and methods: This 2-month, open-label, real-life, multicentre, observational study was undertaken by 499 general practitioners in Belgium. Patients (≥?4?years old) with uncontrolled asthma despite fluticasone/salmeterol or budesonide/formoterol therapy had oral montelukast 4, 5, or 10?mg daily added to their therapy, depending on the registered dose for their age. Asthma control, assessed by the 6-item Juniper Asthma Control Questionnaire (ACQ) was recorded at baseline and after 2?months of treatment with montelukast and the patients’ global evaluation of asthma was also recorded at the end of the study. Concomitant allergic rhinitis symptoms were evaluated according to the patients’ perception.

Results: A total of 5769 patients were eligible for analysis. Addition of montelukast was associated with significant decrease in mean (SD) ACQ score (from 1.97 [0.77] at baseline to 1.05 [0.69] after add-on treatment, p?<?0.001). There was also a significant improvement in all individual symptoms of the ACQ score (p?<?0.001). After 2?months, 89% of the patients reported global improvement of their asthma, with a good correlation between patients’ global evaluation and change in ACQ scores. Of the 2442 patients who reported allergic rhinitis symptoms at baseline, 91% showed a global improvement of their asthma symptoms and 82% in their rhinitis symptoms after adding montelukast.

Conclusion: This open-label observational study showed an improvement, after 2?months of add-on therapy with montelukast, in both asthma and allergic rhinitis symptoms in patients not adequately controlled on a fixed association of ICS/LABA.     

The impact of a medical food containing gammalinolenic and eicosapentaenoic acids on asthma management and the quality of life of adult asthma patients

ABSTRACT

Background: Leukotriene synthesis inhibitors and receptor antagonists are efficacious for the treatment of asthma. Diets containing the fatty acids gammalinolenic acid (GLA) and eicosapentaenoic acid (EPA) decrease leukotriene synthesis; however, their impact on asthma management and quality of life (QOL) has not been evaluated in asthmatic subjects.

Objective: To evaluate asthma management and the QOL of asthmatic adult subjects consuming a medical food emulsion containing GLA and EPA.

Research design and methods: Trial 1 was a random­ized, prospective, double-blind, placebo-controlled, parallel group trial in atopic subjects with mild-to-moderate asthma (n = 35 evaluable) consuming a low dose (0.75?g GLA + 0.5?g EPA), high dose (1.13?g GLA + 0.75?g EPA) or placebo emulsion daily. Subjects were questioned about their asthma management using a non-validated questionnaire after 2 and 4 weeks. Blood leuko­trienes were measured at baseline and after 4 weeks. Trial 2 was an open-label study (n = 65 evaluable) where subjects consumed the low-dose medical food emulsion, EFF1009, daily. QOL and asthma management were measured using the validated Mini Asthma Quality of Life (MiniAQLQ) and the Asthma Control (ACQ) questionnaires, respectively, administered at baseline and after 4 weeks.

Results: In Trial 1, leukotriene biosynthesis decreased (?p < 0.05). Self-reported asthma status and broncho­dilator use improved in subjects consuming low- and high-dose emulsion between week 2 and week 4 (?p < 0.01), but not compared to placebo (?p > 0.1). In Trial 2, mean ± standard error total MiniAQLQ and ACQ scores improved by 1.5 ± 0.2 and 1.0 ± 0.1, respectively (?p < 0.001). Subdomain scores from MiniAQLQ improved and rescue bronchodilator use decreased (?p < 0.001).

Conclusion: The inclusion of the medical food EFF1009 in asthma management regimens can improve patient quality of life and decrease reliance on rescue medication.     

The variability of asthma

ABSTRACT

Asthma is a chronic disease of airway inflammation that affects all age groups. Despite national treatment recommendations and the availability of effective controller medications, asthma morbidity remains pervasive and currently represents a considerable socio-economic burden. Asthma may be intermittent or persistent; persistent asthma may be mild, moderate, or severe. Many factors influence asthma severity, both on a short-term basis and over time. In individual patients, asthma severity may fluctuate because of physiologic, environmental, socioeconomic, or behavioral factors. Inhaled corticosteroids (ICSs) are safe and well tolerated, and are the preferred long-term treatment for controlling persistent asthma of all severities in adults and children. Awareness of episodic changes in asthma severity, with subsequent tailored adjustment in guideline-based ICS therapy, should enable optimal control of asthma with minimal medication requirements.     

A psychometric comparison of three patient-based measures of asthma control

ABSTRACT

Objective: Asthma is a multidimensional disease, characterized by changes in pulmonary function, transient and chronic symptoms, and effects on quality of life. In this study, we compared the psychometric properties and screening accuracy of three patient-based asthma control instruments including: the Asthma Control Test (ACT), a brief instrument developed to assess asthma control of patients in a clinical setting; the Asthma Control Questionnaire (ACQ), an instrument developed for use in clinical research; and the ‘Rules of Two’, a tool that has been used in both settings.

Methods: Patients (N = 313) completed the ACT, ACQ, and Rules of Two during two asthma clinic visits 4–12 weeks apart. Office staff recorded pre- and post-bronchodilator FEV₁ measurements and asthma specialists provided a global rating of asthma control. Internal consistency reliability was computed and construct validity was evaluated using analysis of variance (ANOVA). Logistic regression and receiving operating characteristic (ROC) curve analysis was conducted to compare the screening accuracy of each measure in identifying patients with uncontrolled or moderate to severe asthma. The responsiveness of each measure to changes in asthma control and severity was tested using correlational and ANOVA methods.

Results: Results show that the ACT and ACQ have comparable reliability, validity, screening accuracy, and responsiveness. The Rules of Two, however, did not meet some standards and therefore has weaker psychometric properties.

Conclusion: The ACT and ACQ are comparable asthma control questionnaires. The choice of which questionnaire to use should be informed by considering several factors, such as the intended purpose and setting where the questionnaire will be used, as well as the content, practicality, availability of benchmark scores, and adaptability to multiple administration modes of each questionnaire. One potential limitation of the study is that the data were collected in a clinical setting with limited demographic information. Hence, additional studies are needed to evaluate the psychometric properties of each instrument across demographic and clinical subgroups of the general population.     

Improving asthma control in patients suboptimally controlled on inhaled steroids and long-acting β2‐agonists: addition of montelukast in an open-label pilot study

ABSTRACT

Background: Airway inflammation and symptoms often persist in asthma patients despite treatment with inhaled corticosteroids (ICS) and long-acting β₂-agonists (LABA). It is hypothesized that the leukotriene receptor antagonist montelukast, treating a pathway of inflammation distinct from that of ICS, might confer additional benefit.

Objective: To evaluate the efficacy of montelukast in improving asthma control in patients symptomatic on a fixed-association (FA) medium dose of ICS and LABA.

Methods: A 2-month, open-label, real-life observational study was undertaken by 131 Belgian pulmonologists. Patients (≥ 15 years old) suffering from persistent asthma (pre-bronchodilator FEV₁ ≥ 60% of predicted value) and insufficiently controlled on a FA therapy of fluticasone/salmeterol or budesonide/formoterol were given montelukast 10?mg daily as add-on therapy. Asthma control was assessed by the standardized Juniper asthma control questionnaire (ACQ) at baseline and after a 2-month treatment with montelukast. Global evaluation of therapy was made both by the patients and physicians.

Results: A total of 313 patients were eligible for analysis. Forty-nine per cent received inhaled fluticasone/salmeterol and the rest budesonide/formoterol. Mean ACQ score decreased significantly on montelukast (13.9 ± 5.1 at baseline versus 7.4 ± 4.7 on montelukast, p < 0.001), with a significant improvement in all individual symptom scores (?p < 0.001) and in pre-bronchodilator FEV₁ score (from 2.2 ± 1.5 to 1.6 ± 1.4; p < 0.001). Parallel to these results, 78.6% of the patients reported a global improvement of their asthma. The same proportion of improvement was observed in the global evaluation made by the physicians (κ = 0.66).

Conclusion: This pilot study suggests that addition of montelukast in patients symptomatic on a FA of ICS and LABA may result in significant improvements in asthma control. A randomised, placebo-controlled clinical trial seems warranted.     

Prostaglandin D2 receptor antagonists in early development as potential therapeutic options for asthma

Introduction: Asthma is a chronic inflammatory disease characterized by bronchial hyper-reactivity. Although many currently available treatment regimens are effective, poor symptom control and refractory severe disease still represent major unmet needs. In the last years, numerous molecular therapeutic targets that interfere with the innate inflammatory response in asthma have been identified. Promising preliminary results concern the signaling cascade promoted by prostaglandin D2 (PGD2) and its receptor antagonists.

Areas covered: The aim of this review is to provide the most recent clinical and preclinical data on the efficacy and safety of newly developed compounds for the treatment of allergic asthma. The authors will present an overview of the pathogenetic molecular mechanisms sustaining the chronic inflammatory response in asthma; the focus will be then directed on the mediators of the PGD2 pathway, the chemoattractant receptor-homologous molecule expressed on TH2 cells, and their latest antagonists developed.

Expert opinion: Bronchodilators and corticosteroids are not sufficient to achieve a satisfactory management of all asthmatic patients; the development of new specific treatments appears therefore essential. The good results in terms of cellular, functional and clinical outcomes, together with an acceptable safety of the CRTh2 antagonists represent a promising start for a tailored management of allergic asthma.     

A retrospective randomized study of asthma control in the US: results of the CHARIOT study

ABSTRACT

Background: The third version of the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report (EPR-3): Guidelines on the Diagnosis and Management of Asthma emphasizes the need to use asthma control rather than patient severity to base adjustments to treatment and ultimately improve patient outcomes. The objectives of the current study were to assess control of patients with moderate-to-severe asthma, examine the natural history of the disease, practice patterns and resource utilization in specialty community practices according to recently reviewed NAEPP guidelines.

Research design and methods: This analysis represents a retrospective, multicenter, randomized study of 1009 patient charts in sixty United States allergy and pulmonary medicine community practices. The proportion of patients with controlled and uncontrolled asthma over 12 months, prevalence and characteristics of atopy, past asthma history, pulmonary function, medications and treatment patterns, patient and clinical practice characteristics were analyzed.

Main outcome measures: The primary outcome of interest was asthma control.

Results: A total of 365 male and 644 female patients with moderate-to-severe persistent asthma (mean 43.2 ± 17.1 years) were enrolled. 81.9% of patients were uncontrolled according to recent NAEPP guidelines. Importantly, a greater percentage of patients with moderate asthma vs. severe persistent asthma were uncontrolled (p < 0.0114). Atopy was detected in 92% of patients. Patients with early onset of asthma were associated with control (p < 0.0433). Atopic symptoms, such as allergic rhinitis (p < 0.0130) and rhinosinusitis (p < 0.0476), were associated with uncontrolled asthma. Uncontrolled patients were also associated with more medications (a mean of 4.05 ± 1.87 medications) than were controlled patients (a mean of 3.40 ± 1.37 medications (p < 0.0001), although the temporal relationship of this association was not recorded. Limitations may have included patient and/or study site selection bias and difficulty in the process of operationalizing the definitions of control and disease severity. Since the current study only examined patients from specialty practices, the results may not be generalizable to the overall asthma population.

Conclusions: Greater than 80% of asthma patients from specialty practices were uncontrolled with regard to asthma symptoms. Atopic symptoms, such as allergic rhinitis and rhinosinusitis, in addition to a greater number of medications, were associated with uncontrolled asthma. Moreover, patients designated as having asthma of moderate severity were associated with being uncontrolled more than were those with severe asthma (p < 0.0114), which suggests that the former population may not have received adequate assessment of impairment or risk, with subsequent changes in treatment for control of symptoms.     

Improvement in quality of life with omalizumab in patients with severe allergic asthma

ABSTRACT

Background: Patients with severe persistent asthma experience daily symptoms and frequent serious exacerbations that contribute to a significant impairment of health-related quality of life (QoL).

Methods: A pooled analysis was completed of six controlled clinical trials that evaluated the effect of add-on omalizumab on asthma-related QoL in patients with severe persistent allergic (IgE-mediated) asthma. Asthma-related QoL was assessed at baseline and treatment endpoint using the well-validated Juniper Asthma Quality of Life Questionnaire (AQLQ). Change from baseline in AQLQ total score was compared between treatments using analysis of covariance methods. The percentage of patients who achieved a clinically meaningful (≥ 0.5-point) improvement in AQLQ total score was compared using the Mantel–Haenszel Chi-square test.

Results: The pooled patient population comprised 2548 patients (omalizumab, n = 1342; control, n = 1206), of whom 96% had severe persistent asthma according to the GINA 2002 classification. Omalizumab produced significantly greater improvements in AQLQ total score vs the control group (mean increases of 1.01 and 0.61 points, respectively; p < 0.001). In addition, significantly more omalizumab-treated patients achieved a clinically meaningful improvement in AQLQ total score than patients in the control group (66.3% vs 52.4%; p < 0.001).

Conclusions: Add-on therapy with omalizumab improves QoL to a significant and clinically meaningful level in patients with severe persistent allergic asthma.     

The effect of budesonide and formoterol in one pressurized metered-dose inhaler on patient-reported outcomes in adults with mild-to-moderate persistent asthma

ABSTRACT

Objective: To determine the effects of budesonide and formoterol administered via one pressurized metered-dose inhaler (budesonide/formoterol pMDI) on patient-reported outcomes (PROs) and to determine the contributions of budesonide and formoterol to those effects in adults with asthma.

Research design and methods: A 12-week, random­ized, double-blind, double-dummy, placebo-controlled, multicenter study was conducted in 480 patients aged ≥?12 years with mild-to-moderate persistent asthma. After a 2-week run-in period during which current asthma therapy was discontinued, patients were randomized to receive two inhalations twice daily of budesonide/formo­terol pMDI 80/4.5?μg (160/9?μg), budesonide pMDI 80?μg (160?μg), formoterol via dry powder inhaler (DPI) 4.5?μg (9?μg), or placebo.

Main outcome measures: Analyses included a subpopulation of 405 patients aged ≥?18 years. PROs included the standardized Asthma Quality of Life Questionnaire (AQLQ(S)), the Medical Outcomes Study (MOS) Sleep Scale, the Patient Satisfaction with Asthma Medication (PSAM) questionnaire, and asthma control variables (recorded via electronic diaries), such as asthma symptoms, rescue medication use, and nighttime awakenings due to asthma. Patient and physician global assessments were collected at the end of the study.

Results: Patients aged ≥?18 years receiving budesonide/formoterol pMDI reported significantly greater improvements from baseline in AQLQ overall and domain scores, MOS Sleep Scale domain scores, and asthma control variables than patients receiving placebo (?p ≤ 0.033). Improvements from baseline in AQLQ(S) overall and domain scores, daily asthma symptoms scores, percentage of symptom-free days, percentage of rescue medication-free days, and percentage of asthma control days were significantly greater in patients receiving budesonide/formoterol pMDI versus formoterol DPI (?p ≤ 0.042). Patients receiving budesonide/formoterol pMDI reported significantly greater PSAM scores than did patients in all other treatment arms (?p ≤ 0.004). Study limitations may include the fact that the formoterol-alone arm used a different device and formulation than the other active arms as well as the absence of a treatment arm with budesonide and formoterol administered concomit­antly in separate inhalers. In addition, these results may not be generalized to all patients with asthma, as this analysis included only patients aged ≥?18 years.

Conclusions: Patients receiving treatment with budesonide/for­moterol pMDI experienced significantly greater improvements from baseline in asthma-related quality of life, quality of sleep, and asthma control and greater satisfaction with treatment than patients receiving placebo. The combination of budesonide and formoterol in one pMDI is beneficial in improving how a patient feels and functions as a result of treatment.     

Asthma control in patients with asthma and allergic rhinitis receiving add-on montelukast therapy for 12 months: a retrospective observational study

ABSTRACT

Background: Montelukast, a potent leukotriene receptor antagonist, is approved for treatment of both asthma and allergic rhinitis (AR). No studies to date have examined whether montelukast can improve asthma control over a long period of time in patients with seasonal AR and asthma.

Objective: To evaluate asthma control and use of asthma-related medical resources by patients with inadequately controlled mild to moderate persistent asthma and seasonal AR who required addition of montelukast as part of routine care.

Methods: This multicenter, 24?month, pre–post retrospective observational study included patients receiving current inhaled corticosteroid (ICS) therapy (alone or in combination with long-acting β-agonist [LABA]), who received add-on treatment with montelukast for 12 consecutive months. The incidence of asthma attacks, defined as emergency department visit, hospitalization, or oral corticosteroid use for asthma, was compared for the year before and the year after addition of montelukast to therapy.

Results: For the 696 patients from Italy, Poland, and Spain who were included in the analyses, the proportion of patients experiencing an asthma attack declined from 31.5% in the year before to 10.1% (?p < 0.001) the year after addition of montelukast to therapy. Proportions of patients with an asthma-related emergency room visit, hospitalization, and oral corticosteroid use declined from 18.7% to 3.9%, from 5.2% to 1.4%, and from 17.5% to 5.9% (all p < 0.01), respectively. The incidence of these outcomes declined in all three countries, regardless of baseline asthma severity or asthma therapy (ICS alone or ICS + LABA). Important study limitations include the possibility of selection bias or missing medical chart data in this retrospective study design. Also noteworthy is the inclusion of only those patients who remained persistent with montelukast therapy. Therefore, the results of the study are relevant for patients who remain persistent with montelukast therapy.

Conclusions: Addition of montelukast to current ICS therapy improved long-term asthma control and resulted in substantial reductions in asthma-related resource use by patients with mild or moderate persistent asthma and concomitant seasonal AR who were persistent with montelukast therapy in this retrospective observational study.     

The effect of adjustable dosing with budesonide/formoterol on health-related quality of life and asthma control compared with fixed dosing

SUMMARY

Background: Budesonide/formoterol in a single inhaler is an effective therapy for asthma. We investigated whether adjustable maintenance dosing with budesonide/formoterol could maintain health-related quality of life (HRQL) and asthma control.

Patients/methods: Asthma patients (n = 4025) received budesonide/formoterol (Symbicort* 160/4.5?µg) 2 inhalations twice daily (bid) for 4?weeks during run-in of this open, multicentre study. Patients were randomised to adjustable dosing (budesonide/formoterol 1 inhalation bid; stepping up to 2 or 4 inhalations bid for 1?week if asthma worsened) or fixed dosing (budesonide/formoterol 2 inhalations bid), for 12?weeks. Change in HRQL (standardised Asthma Quality of Life Questionnaire, AQLQ[S], score) during randomised treatment was the primary efficacy variable. Secondary variables included asthma control (peak expiratory flow [PEF], symptom-severity score, nocturnal awakenings, reliever-medication use) and study-medication intake.

Results: Clinically significant (≥ 0.5) improvements in AQLQ(S) score (mean 0.73), morning and evening PEF (mean 42.5 and 24.8?L/min, respectively), and symptom-severity score (mean 0.36) were achieved during run-in. The improvements were maintained in both groups although, overall, adjustable-dosing patients took fewer daily inhalations of budesonide/formoterol than fixed-dosing patients (mean 2.63 versus 3.82, p < 0.001).

Conclusion: Adjustable maintenance dosing with budesonide/formoterol maintains HRQL and asthma control as effectively as fixed dosing and is associated with a reduced drug load overall.     

A case series on lung deposition analysis of inhaled medication using functional imaging based computational fluid dynamics in asthmatic patients: effect of upper airway morphology and comparison with in vivo data

Context: Asthma affects 20 million Americans resulting in an economic burden of approximately $18 billion in the US alone (Allergies and Asthma Foundation 2000; National Center for Environmental Health (NCEH) 1999). Research studies based on differences in patient-specific airway morphology for asthma and the associated effect on deposition of inhaled aerosols are currently not available in the literature. Therefore, the role of morphological variations such as upper airway (extrathoracic) occlusion is not well documented.

Objective: Functional imaging based computational fluid dynamics (CFD) of the respiratory airways for five asthmatic subjects is performed in this study using computed tomography (CT) based patient-specific airway models and boundary conditions.

Methods: CT scans for 5 asthma patients were used to reconstruct 3D lung models using segmentation software. An averaged inhalation profile and patient-specific lobar flow distribution were used to perform the simulation. The simulations were used to obtain deposition for BDP/Formoterol^® HFA pMDI in the patient-specific airway models.

Results: The lung deposition obtained using CFD was in excellent agreement with available in vivo data using the same product. Specifically, CFD resulted in 30% lung deposition, whereas in vivo lung deposition was reported to be approximately 31%.

Conclusion: It was concluded that a combination of patient-specific airway models and lobar boundary conditions can be used to obtain accurate lung deposition estimates. Lower lung deposition can be expected for patients with higher extrathoracic resistance. Novel respiratory drug delivery devices need to accommodate population sub-groups based on these morphological and anatomical differences in addition to subject age.     

Resource utilization in asthma:combined fluticasone propionate/salmeterol compared with inhaled corticosteroids

ABSTRACT

Background: Asthma management guidelines recommend low-dose inhaled corticosteroids (ICS) for initial treatment of mild persistent asthma. Instead, data from primary care practice show that many patients start on combination therapy with fluticasone propionate/salmeterol (FPS) for mild asthma. The consequences of this variance from guideline recommendations are not well described.

Objective: Compare healthcare utilization and asthma-related outcomes for patients with mild asthma who began treatment with FPS or ICS alone.

Design and data source: A retrospective analysis of asthma-related insurance claims. Patients initially treated with FPS or ICS were identified from an administrative health insurance claims database and followed for 1 year. Analyses of resource utilization 6 months before therapy initiation identified patients with mild asthma. Propensity score matching managed between-group differences in clinical characteristics and controlled for selection bias.

Outcome measures: Resource use was determined for asthma-related outpatient visits, emergency room services, hospitalizations, and medications.

Results: Demographic characteristics and comorbidities were similar for each group (FPS, n = 1888; ICS, n = 1888). During the 12?month follow-up period, total asthma-related costs were significantly higher for FPS versus ICS ($1206 vs. $804; p < 0.0001), owing primarily to significantly higher drug costs for FPS versus ICS ($677 vs. $357; p < 0.0001). The percentage of patients experiencing an exacerbation (14.0% FPS, 13.5% ICS) and the average number of exacerbations in each group (0.175 FPS, 0.164 ICS) were similar.

Conclusions: Healthcare costs were found to be lower in patients receiving ICS than in those receiving FPS, with similar health outcomes in both groups. Study limitations included the use of claims data and a proxy definition of asthma severity, and potential confounding by unobserved factors.     

Effectiveness of budesonide nebulising suspension compared to disodium cromoglycate in early childhood asthma

ABSTRACT

Objective: The optimal treatment for early childhood asthma remains controversial. Budesonide (BUD) has shown superiority over placebo in infants, and over disodium cromoglycate (DSCG) in children aged > 2 years. The aim of this double-blind, randomised, parallel-group study was to compare the effectiveness of nebulised BUD and DSCG in asthmatic children aged < 36 months.

Research design and methods: 82 infants (mean age 18.0 months [range, 11.6–31.2 months]) with suspected asthma (three exacerbations of dyspnoea and wheezing during the past 12 months, with one or more exacerbations in the past 3 months) were treated for 3 months with nebulised BUD (Pulmicort Respules) 0.5?mg/2?mL bid or DSCG 20?mg/2?mL tid. Follow-up was at 6 months.

Main outcome measures and results: Patients treated with BUD had a lower exacerbation rate than DSCG-treated patients after 3 months of treatment (5.4% vs. 31.7%; p = 0.003) and towards the end of follow-up (30% vs. 49%; p = 0.062). During treatment, days without cough were 80% and 65% for BUD and DSCG, respectively (?p = 0.014), and nights without cough were 89% and 78%, respectively (?p = 0.016). Side-effects were mild and of similar frequency in both groups.

Conclusions: Inhaled nebulised BUD was well tolerated and more effective than nebulised DSCG in reducing the incidence of asthma exacerbations and days with symptoms. These beneficial effects of BUD were maintained throughout the 6‐month follow-up.