ASTHMA MedDRA version: 6.1 Level: PT Classification code 10003553
Conditions
Interventions
Product Name: beclomethasone dipropionate extrafine combined with formoterol fumarate
Pharmaceutical Form: Pressurised inhalation, solution
Concentration unit: µg microgram(s)
Concentration type: equa
Sponsors
CHIESI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be enrolled into the 4 weeks run-in period if they meet the following criteria: Male or female patients aged major and equal 18 years and smaller and equal 50 years; Clinical diagnosis of moderate persistent asthma for at least 6 months, according to GINA revised version 2002 guidelines (1): Forced expiratory volume (FEV1) or PEF majoe and equal 60% of the predicted normal value; or moderate asthma as defined by clinical and functional features taking into account current treatment schedule, in patients already treated. Positive response to the reversibility test in the screening visit, defined as an increase of at least 12% (or, alternatively, of 200mL) from baseline value in the measurement of FEV1 30 minutes following 4 puffs (4 x 100 ?g) of inhaled salbutamol administered via pMDI or a positive methacholine test (defined as PC20=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Inability to carry out pulmonary function testing; Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (30); History of near fatal asthma; Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks; Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months; Patients who have changed their dose of inhaled corticosteroids during the previous 4 weeks, or treatment with inhaled corticosteroids at a daily dose > 1000 mcg of BDP or equivalent , taking into account the ratios between different steroids reported in guidelines (1); Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 cigarettes/day; History or current evidence of: heart failure; coronary artery disease; myocardial infarction; severe hypertension; cardiac arrhythmias, abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females; haemodynamic relevant rhythm disturbances including atrial flutter or atrial fibrillation with ventricular response, bradicardia (smaller and equal 55 bpm), evidence of atrial-ventricular (AV) block on ECG of more than 1st degree; Diabetes mellitus; Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous six months; Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic or renal impairment, poorly controlled pulmonary (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g. active peptic ulcer), neurological or haematological autoimmune diseases; Cancer or any chronic diseases with prognosis < 2 years; Pregnant or lactating females or females at risk of pregnancy, i.e. those not demonstrating adequate contraception (i.e. barrier methods, intrauterine devices, hormonal treatment or sterilization). A pregnancy test is to be carried out in women of a fertile age. History of alcohol or drug abuse; Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers as regular use; Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients; Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; Patients who received any investigational new drug within the last 12 weeks; Patients who have been previously enrolled in other clinical studies; Patients with asthma exacerbations requiring treatment with oral corticosteroids or hospitalization during the run-in period will also be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of beclomethasone plus formoterol combination in HFA versus seretide Diskus on functional parameters and inflammatory markers in adult patients with asthma.;Secondary Objective: N.A.;Primary end point(s): N.A. | — |
Countries
Italy
Outcome results
None listed