Asthma is a serious global health problem. People of all ages in countries throughout the world are affected by this chronic airway disorder that can be severe and sometimes fatal. The prevalence of asthma is increasing everywhere, especially among children.According to international guidelines, once control of asthma is achieved and maintained for at least 3 months, a gradual reduction of the maintenance therapy should be tried in order to identify the minimum therapy required to maintain control. This will help reduce the risk of side effects and enhance patient adherence to the treatment plan. Reduction of therapy in patients on combination therapy should begin with a reduction in the dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped down. Stepping-down will be attempted with two medications: a new combination of extrafine beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and, alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference medication) without losing asthma control.If this hypothesis will be confirmed, the present study will demonstrate that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs. Given the aims of this study, the population to be monitored includes adult patients with moderate persistent asthma, which can be defined controlled according to the current guidelines under standard stabilised treatment. The intended treatment duration is therefore designed to ensure that good control of asthma is firmly achieved before stepping down the treatment (8 weeks run-in period), but also that the condition of the patients are followed long enough (24 weeks comparative treatment period) to ensure that a new stable condition is also obtained and properly monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
382
100+6 pMDI
diskus 250/50
Clinic of Pulmonology, UMHAT "Sveti Georgi"
Plovdiv, Bulgaria
First Department of Pulmonology, Regional Dispensery of Pulmonology and Phtisiatric Diseases with Stationary (RDPPDS)
Rousse, Bulgaria
Clinic of Pulmonology, University Hospital "Lozenetz"
Sofia, Bulgaria
First Internal Clinic, Endocrinology and Pulmonology Department MHAT
Stara Zagora, Bulgaria
U.O.C. S.Anna e S. Sebastiano - Malattie dell'apparato respiratorio
Caserta, Italy
Ospedale S. Camillo de Lellis - U.O.C. Pneumologia
Chieti, Italy
Ospedale Cardarelli - Fisiopatologia Respiratoria
Naples, Italy
CNR - Dipartimento di Fisiopatologia Respiratoria
Palermo, Italy
Department of Hospital Pediatrics Crimean State Medical University. Pulmonology Department of Republican Clinical Children's Hospital
Crimea, Ukraine
Pulmonological and Allergological Department of the Kharkov Regional Clinical Hospital
Kharkiv, Ukraine
...and 8 more locations
Morning pre-dose PEF measured daily by patients (mean of the last 2 weeks of treatment period).
Time frame: mean of the last 2 weeks of treatment period
symptom scores and symptom free days
Time frame: in the whole study period and every 2-week period
morning and evening pre-dose PEF and FEV1 measured daily by patients;
Time frame: daily and mean each 2-week period
pulmonary function tests measured at clinics (pre-dose PEF, FVC and FEV1);
Time frame: at aech clinic visit
change of FEV1 from pre-dose to 5, 15, 30 and 60 minutes post-dose;
Time frame: randomization visit and end of treatment visit
number, frequency and severity of exacerbations, time to first exacerbation
Time frame: whole study period
adverse events and adverse drug reactions
Time frame: retrospectively assessed at each visit
use of relief salbutamol and days without use of relief salbutamol;
Time frame: daily
proportion of patients with controlled asthma and partly controlled asthma, weeks of controlled asthma and partly controlled asthma;
Time frame: weekly
pharmaco-economic analysis of medical and non medical costs.
Time frame: during study period
12 h-overnight urinary cortisol/creatinine
Time frame: (collected at visit 3, 6 and 9)
vital signs
Time frame: at each visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.