Trend of Bronchial Hyperresponsiveness to Methacholine as a Cost Predictor of Mild-to-Moderate Asthma: A Twelve-Month Survey in Teenagers.

Bronchial asthma is characterized by variable airflow obstruction, airway inflammation, and bronchial hyperresponsiveness (BHR) to non-specific stimuli. The role of underlying airway inflammation and of related long-lasting BHR has been suboptimally investigated in teenagers with mild-to-moderate asthma, as has the corresponding economic impact over time. The aim of the present study was to calculate the cost of mild-to-moderate atopic asthma in teenagers arising from their degree of persisting BHR over a twelve-month period. METHODS: Patients aged 12-18 years with mild-to-moderate symptoms treated with fluticasone fumarate/vilanterol 92/22 mcg daily were retrospectively followed for 12 months. Usual spirometric parameters, BHR to methacholine (MCh), and resource consumption (visits, hospitalizations, systemic steroids and/or antibiotics courses, school days off) were assessed at recruitment (the index date) and after 6 and 12 months. Adherence to treatment was also calculated. The cost of asthma was calculated based on Italian tariffs and published papers. The trend over time in BHR and the association between response to MCh and total cost were investigated by using regression models adjusted for repeated measures. RESULTS: 106 teenagers (53 males, age 15.9 ± 1.6 years) were investigated. The annual cost of asthma proved significantly related to the BHR trend: every increment of a factor 10 in the response to MCh was associated with a saving of EUR 184.90 (95% CI -305.89 to -63.90). BHR was progressively optimized after 6 and 12 months in relation to the patients' compliance to treatment (≥70% of prescribed inhalation doses). CONCLUSIONS: the usual spirometric parameters are largely insufficient to reflect the effects of underlying persistent inflammation in milder forms of asthma in teenagers. In terms of clinical governance, the periodic assessment of non-specific BHR is the appropriate procedure from this point of view. Non-specific BHR proves a reliable procedure for predicting and monitoring the economic impact of mild-to-moderate asthma in teenagers over time.

The Extra Cost Due to Non-Adherence to Inhaled Treatments in Adolescents with Mild-to-Moderate Persistent Asthma.

Bronchial asthma has a high socio-economic impact in Western countries. Low adherence to prescribed inhalation treatments contributes to poor asthma control and the higher utilization of healthcare resources. Although adolescents usually do not comply with long-term inhaled treatments prescribed on a regular basis, the related economic consequences still are poorly investigated in Italy. AIM: A 12-month estimation of the economic impact of non-adherence to inhalation treatments in adolescents with mild-to-moderate atopic asthma. METHODS: Non-smoking adolescents aged 12-19 years, without any significant comorbidity, prescribed with inhaled cortico-steroids (ICS) or ICS/long-acting beta(2)-adrenergics (LABA) via dry powder inhalers (DPIs) on a regular basis were automatically selected from the institutional database. Spirometric lung function, clinical outcomes, and pharmacological information were collected. The adolescents' adherence to their prescribed regimen was calculated monthly. Adolescents were divided in two sub-groups based on their adherence to prescriptions: ≤70% (not adherent) or >70% (adherent), and statistically compared (Wilcoxon test, assuming p < 0.05). RESULTS: Overall, 155 adolescents fulfilled the inclusion criteria (males, 49.0%; mean age, 15.6 years ± 2.9 SD; mean BMI, 19.1 ± 1.3 SD). Mean values of lung function were: FEV1 = 84.9% pred. ± 14.8 SD, FEV1/FVC = 87.9 ± 12.5 SD; MMEF = 74.8% pred. ± 15.1 SD and V25 = 68.4% pred. ± 14.9 SD. ICS had been prescribed in 57.4% of subjects and ICS/LABA in 42.6%. Mean adherence to original prescriptions was 46.6% ± 9.2 SD in non-adherent and 80.3% ± 6.6 SD in adherent adolescents, respectively (p < 0.001). The mean rates of hospitalizations, exacerbations, and GP visits; the average duration of absenteeism; the frequency of systemic steroids and antibiotics courses needed over the study period were significantly and substantially lower in adolescents adherent to prescriptions (all p < 0.001). The mean total annual extra cost calculated in the two sub-groups was EUR 705.8 ± 420.9 SD in non-adherent adolescents and EUR 192.1 ± 68.1 SD in adherent adolescents, respectively (p < 0.001), which was 3.7 times higher than in non-adherent adolescents. CONCLUSIONS: In adolescents, the clinical control of mild-to-moderate atopic asthma is directly and strictly related to the degree of adherence to prescribed inhalation therapies. All clinical and economic outcomes prove dramatically poor when adherence is low, and treatable asthma can be frequently mistaken for refractory asthma in these cases. Adolescents' non-adherence impacts the burden of the disease quite substantially. Much more effective strategies centered specifically on adolescents' asthma are needed.

Uncontrolled Asthma: Unmet Needs in the Management of Patients.

The recent scientific research has provided clinicians with the tools for substantially upgrading the standard of care in the field of bronchial asthma. Nevertheless, satisfactory asthma control still remains an unmet need worldwide. Identifying the major determinants of poor control in different asthma severity levels represents the first step towards the improvement of the overall patients' management. The present review aims to provide an overview of the main unmet needs in asthma control and of the potential tools for overcoming the issue. Implementing a personalized medicine approach is essential, not only in terms of pharmacological treatments, biologic drugs or sophisticated biomarkers. In fact, exploring the complex profile of each patient, from his inflammation phenotype to his preferences and expectations, may help in filling the gap between the big potential of currently available treatments and the overall unsatisfactory asthma control. Telemedicine and e-health technologies may provide a strategy to both optimize disease assessment on a regular basis and enhance patients' empowerment in managing their asthma. Increasing patients' awareness as well as the physicians' knowledge about asthma phenotypes and treatment options besides corticosteroid probably represent the key and more difficult goals of all the players involved in asthma management at every level.

Fluticasone furoate/vilanterol 92/22 µg once a day: a 12-month study on outcomes in mild to moderate asthma.

BACKGROUND: Fluticasone furoate/vilanterol (FF/V) is an effective long-acting ß2 agonist/inhaled corticosteroid combination for managing persistent bronchial asthma. The aim of the study was to assess the outcomes achievable in patients with mild to moderate asthma receiving FF/V 92/22 µg once daily for 12 months. METHODS: Data were automatically and anonymously obtained from the institutional database: forced expiratory volume in 1 s predicted values; the exacerbation and hospitalization rates; days of hospitalization; general practitioner (GP) or specialist visits; days of inactivity; courses of systemic steroids or antibiotics were recorded at baseline and after 3, 6 and 12 months of treatment. The overall adherence to treatment was also calculated. Analysis of variance was used for checking the trends of variables. The improvement in lung function was significant ( p < 0.001) and time dependent. The mean (±standard error) exacerbation rate per patient changed from 1.05 (±0.16) at baseline to 0.28 (±0.07) after 3 months, 0.33 (±0.08) after 6 months and 0.18 (±0.08) after 12 months ( p < 0.001). The mean hospitalization rate per patient changed from 0.30 (±0.07) at baseline to 0.08 (±0.04) after 3 months, 0.10 (±0.05) after 6 months and 0.03 (±0.03) after 12 months ( p < 0.001). Also mean duration of hospitalization and days of inactivity were reduced over time ( p < 0.001). GP visits were also reduced, together with specialist visits (both p < 0.001). Steroid and antibiotic courses dropped significantly ( p < 0.001 and p < 0.001, respectively). Moreover, changes in all outcomes considered proved time dependent, particularly over the second semester. Finally, over time, adherence to treatment was high. CONCLUSIONS: The once-daily inhalation of combined FF/V 92/22 µg optimized systematically the exacerbation and hospitalization rates in mild to moderate asthma, together with all other outcomes over time. The effectiveness of FF/V 92/22 µg once daily proved to be time dependent over the period of the study.

Fluticasone furoate/Vilanterol 92/22 µg once-a-day vs Beclomethasone dipropionate/Formoterol 100/6 µg b.I.D.: a 12-month comparison of outcomes in mild-to-moderate asthma.

BACKGROUND: Bronchial asthma is an inflammatory disease of the airways. Beclomethasone dipropionate/Formoterol (BDP/F) and Fluticasone furoate/Vilanterol (FF/V) are two of the most effective LABA/ICS combinations for managing persistent bronchial asthma. Aim of the study was to compare the outcomes achieved in mild-to-moderate asthma patients assuming BDP/F 100/6 µg b.i.d. (Group A) or FF/V 92/22 µg once-daily (Group B) for 12-months. No head-to-head long-term comparison is available at present. METHODS: Data were automatically and anonymously obtained from the institutional database: FEV1% predicted values; the exacerbation and hospitalization rates; days of hospitalization; GP and/or specialist visits; days of inactivity; courses of systemic steroids and/or antibiotics were recorded at baseline and after 3, 6 and 12 months of both treatments. The overall adherence to treatments was also calculated. The propensity score method was used for matching and comparing the two cohorts of patients; Anova and Wilcoxon tests were used for checking the trends and time-to-time comparisons over the period; statistical significance was accepted for p < 0.05. RESULTS: The PS-matching process returned a cohort of 40 group A patients matched with 40 patients of group B, fully comparable for demographics, clinical characteristics, and comorbidities. The improvement in lung function was significant in both groups (p < 0.001), even if it was significantly higher and time-dependent in group B. The mean (±SE) exacerbation rate/patient changed from 0.63 (±0.13) at baseline to 0.53 (±0.12) after three; to 0.58 (±0.13) after six, and to 0.60 (±0.18) after twelve months in group A (p = ns), while from of 1.05 (±0.16) at baseline, to 0.28 (±0.07) after three; to 0.33 (±0.08) after six, and to 0.18 (±0.08) after twelve months in group B (p < 0.001), respectively. The mean hospitalization rate/patient changed from 0.25 ± 0.07 at baseline to 0.15 (±0.06) after three; to 0.08 (±0.04) after six, and to 0.13 (±0.05) after twelve months in group A (p = ns), while from 0.30 (±0.07) at baseline to 0.08 (±0.04) after three; to 0.10 (±0.05) after six, and to 0.03 (±0.03) after twelve months in group B (p < 0.001), respectively. Also mean duration of hospitalization and days of inactivity were in favour of FF/V treatment over time (in both cases p < 0.001). GP's visits were reduced by both treatments (p < 0.007 in group A and p < 0.001 in group B, respectively, while Specialist's visits only dropped during FF/V (p < 0.001). Steroid and antibiotic courses were significantly reduced by both treatments, even if more systematically in group B (p < 0.001 vs p < 0.007, and p < 0.001 vs p < 0.044, respectively). Moreover, changes in all outcomes considered proved time-dependent during the FF/V treatment only, particularly over the second semester. Finally, the overtime adherence to treatment was higher by 22 days during FF/V . CONCLUSIONS: Both the ICS/LABA combinations proved effective, even if characterized by different patterns of effectiveness either in terms of lung function and of long-term clinical outcomes. Only the once-daily inhalation of combined FF/V 92/22 µg once-daily optimized systematically the exacerbation and hospitalization rates in mild-to-moderate asthma, together with all other outcomes over time. The effectiveness of FF/V 92/22 once-daily µg proved progressive and time-dependent over the twelve-month period of the study, and associated to a higher adherence to treatment.

Comparative features of Asthma with frequent or infrequent exacerbations: A longitudinal study of retrospective and prospective events.

BACKGROUND: A "frequent exacerbator phenotype" has been described, mostly in the population of patients with severe asthma. Further data are needed on such exacerbation-prone patients in milder asthma. AIM: To compare the characteristics of frequent and nonfrequent exacerbators in asthma of different severities and to assess the stability of the exacerbator status. METHODS: This was an observational study comparing baseline data from frequent (≥2 exacerbations in the past year) and nonfrequent (<2 exacerbations in the past year) exacerbators. Patients were also followed up for one year. Information regarding clinical, physiologic, and inflammatory characteristics was collected at baseline and one-year follow-up. RESULTS: Forty-seven frequent and 53 nonfrequent exacerbators were recruited. No specific clinical, physiologic, or inflammatory characteristic was observed in the frequent as compared to the nonfrequent exacerbators at baseline. Fifty-eight percent of patients reporting frequent exacerbations at baseline remained in this group after one year of follow-up. Forty-two and 62% of patients with, respectively, mild-to-moderate asthma and severe asthma had frequent exacerbations. In a post hoc analysis according to asthma severity, frequent exacerbators with severe asthma had a higher body mass index and poorer asthma control, although they reported higher adherence to medication, in comparison to frequent exacerbators with mild-to-moderate asthma. No specific characteristics could discriminate between frequent and nonfrequent exacerbators of the same asthma severity. CONCLUSIONS: Frequent exacerbators with severe asthma present some specific characteristics not observed in frequent exacerbators with mild-to-moderate disease. However, the latter group should be identified to reassess treatment needs and potential contributing factors.