1-year prospective real life monitoring of asthma control and quality of life in Italy

Abstract

ObjectivesThe study aimed at prospectively evaluating the evolution of asthma control in Italy, to evaluate the reasons for lack of asthma control, perceived quality of life (QoL) and association with level of asthma control, the impact of pharmacological treatment, the number of exacerbations and the healthcare resource consumption.MethodsPRISMA (PRospectIve Study on asthMA control) was an observational study performed in asthmatic patients including a cross-sectional phase and a 12-month prospective phase. Asthma control was assessed with the Asthma Control Test™ (ACT) and QoL was evaluated with EuroQoL-5D questionnaire filled in and collected during 5 clinic visits together with all the other data.ResultsThe prospective phase included 1017 patients with uncontrolled (55.7%) or partly controlled asthma (44.3%). Out of the 739 patients evaluable after 12 months, 22.2% achieved full asthma control (ACT score = 25) and 58.7% reached a good control (ACT score: 20–24). The improvement in asthma control was associated with improved QoL and reduced hospital visits. The main reasons for lack of asthma control were comorbidities, continued exposure to irritants/triggers and poor adherence to therapy. The frequency of exacerbations was lower in patients with controlled asthma.A fixed combination therapy with an inhaled corticosteroid and a long-acting β2 agonist was reported by 77.0% of patients. A better asthma control and improved QoL were achieved with extrafine beclomethasone/formoterol compared to either budesonide/formoterol or fluticasone/salmeterol.ConclusionsAn improvement in asthma control and QoL can be achieved during a 1-year monitoring in a real life setting. Extrafine beclomethasone/formoterol was associated with significant benefit in terms of asthma control and QoL compared to large-particles combinations.ClinicalTrials.gov number NCT01110460.

Control of asthma in adults treated with beclomethasone and formoterol in extrafine particle formulation in a real-life setting in Poland: the CASPER noninterventional, observational trial

“…In a 1-year follow-up of a group of 1017 Italian patients with uncontrolled or partly controlled asthma performed in real-life conditions, the use of an extrafine BDP/F-pMDI HFA combination was associated with considerably better asthma control and improved quality of life as compared with non-extrafine fixed-dose ICS/LABA combinations with a mean daily dose of steroids 2-fold lower for extrafine BDP/F (BDP, 318 µg) compared with either budesonide and formoterol combination (BUD/F; BUD, 651 µg) or fluticasone and salmeterol combination (FP/S; FP, 750 µg). 18 This beneficial effect can be due to the extrafine drug formulation, which is characterized by better deposition in the small airways, more equal distribution throughout the bronchial tree, and is less influenced by an improper inhalation technique.…”

“…15,16 According to previous study results, the BDP/F-pMDI HFA proved more effective in achieving asthma control and resulted in improved quality of life. [16][17][18] The objective of this noninterventional study was to assess long-term asthma control, the patient's opinion on the pMDI and satisfaction with therapy, and safety of the extrafine aerosol formulation of the BDP/F combination in a real-life setting in Poland. The effect of training in the correct inhaler technique on asthma control in patients was also assessed.…”

Self-perceived Sleep Quality and Quantity in Adults With Asthma: Findings From the CosteAsma Study

“…It is recommended that the ACT should be taken at different times of the year. We classified degree of asthma control into 4 categories based on ACT scores [9]: uncontrolled asthma (≤15 points), partly controlled asthma (16)(17)(18)(19), controlled asthma (20)(21)(22)(23)(24), and fully controlled asthma (25 points).…”

Treatment response according to small airway phenotypes: a real-life observational study

“…smokers, elderly patients, and patients with comorbidities). Just a few reports of real-life studies have been recently published indicating the efficacy and safety of asthma treatments in different patient groups not normally included in RCTs but further data are needed [Terzano et al 2012;Allegra et al 2012;Muller et al 2011;Brusselle et al 2012]. Moreover, the need for examining small airways function is everyday practice, and further investigating the effects of extrafine ICSs have been advocated [Ivancso et al 2013].…”

“…The fixed combination of beclometasone dipropionate and formoterol (BDP/F, Foster ® , Chiesi Farmaceutici, Italy) 100/6 μg is characterized by extrafine particle size, which results in improved lung deposition and uniform treatment of asthma symptoms throughout the entire bronchial tree [De Backer et al 2010;Huchon et al 2009]. This translates into greater asthma control and quality of life when compared with largerparticle ICS/LABA fixed combinations [Terzano et al 2012;Allegra et al 2012;Muller et al 2011]. Recently, extrafine BDP/F was shown to effectively prolong time to first severe exacerbation when used for both maintenance and reliever therapy (MART) in patients with uncontrolled asthma [Papi et al 2013].…”