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

Claudio Terzano, Giovanni Cremonesi, Giuseppe Girbino, Eleonora Ingrassia, Serafino Marsico, Gabriele Nicolini, Luigi Allegra, PRISMA (PRospectIve Study on asthMA control) Study Group, Claudio Terzano, Giovanni Cremonesi, Giuseppe Girbino, Eleonora Ingrassia, Serafino Marsico, Gabriele Nicolini, Luigi Allegra, PRISMA (PRospectIve Study on asthMA control) Study Group

Abstract

Objectives: The 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.

Methods: PRISMA (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.

Results: The 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.

Conclusions: An 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.

Figures

Figure 1
Figure 1
Patient flow. Patients were considered as drop-out if they definitely withdrew from the study; patients were considered as lost to follow-up if they missed one visit but they attended to a subsequent follow-up visit.
Figure 2
Figure 2
Evolution of asthma control during the 12-month prospective phase. Data are presented as percentage of patients in each category of asthma control: fully controlled (ACT score = 25), controlled (ACT score: 24–20), partly controlled (ACT score: 19–16) and uncontrolled (ACT score ≤ 15).
Figure 3
Figure 3
Percentage of patients treated with different ICS/LABA fixed combinations with fully controlled (ACT score = 25), controlled (ACT score: 24–20), partly controlled (ACT score: 19–16) and uncontrolled (ACT score ≤ 15) asthma at the 12-month follow-up visit. BDP/F = beclomethasone/formoterol; BUD/F = budesonide/formoterol; FP/S = fluticasone/salmeterol. *Bonferroni’s corrected p < 0.001 BDP/F vs. BUD/F (for fully controlled patients).
Figure 4
Figure 4
Quality of life (EQ-5D score and VAS) in patients treated with different ICS/LABA fixed combinations at the 12-month follow-up visit. BDP/F = beclomethasone/formoterol; BUD/F = budesonide/formoterol; FP/S = fluticasone/salmeterol. Data are means. *Bonferroni’s corrected p = 0.001 BDP/F vs. BUD/F; §Bonferroni’s corrected p < 0.001 BDP/F vs. BUD/F and FP/S.
Figure 5
Figure 5
Percentage change in healthcare resource consumption due to asthma from 3 months before the cross-sectional phase visit to 3 months before the 12-month follow-up visit. *p < 0.001 for all comparisons.

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