1-year prospective real life monitoring of asthma control and quality of life in Italy
1 Respiratory Diseases Unit, Department of Cardiovascular and Respiratory Sciences, ‘Sapienza’ University of Rome, Viale del Policlinico 155, 00161, Rome, Italy
2 Medical Affairs Department, Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122, Parma, Italy
3 Institute of Respiratory Medicine, University of Messina, Via Consolare Valeri, Gazzi, 98125, Messina, Italy
4 Department of Respiratory Medicine, Azienda Ospedaliera Monaldi, Second University of Naples, Via Leonardo Bianchi, 80131, Naples, Italy
5 Thoracopulmonary Department, University of Milan, Fondazione IRCCS Cá Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 28, 20122, Milan, Italy
Respiratory Research 2012, 13:112 doi:10.1186/1465-9921-13-112Published: 6 December 2012
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.
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.
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.
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.