A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS. - FACTO study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 452

Inclusion Criteria

1.Written informed consent obtained
2.Adult male and female (=18 and =65 years)
3.Clinical diagnosis of controlled asthma according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2007 in the previous week before study entry:
-no daytime symptoms (twice or less/week)
-no limitations of activities
-no nocturnal symptoms/awakenings
-no need for reliever/rescue medications (twice or less/week)
-lung function (FEV1) = 80% predicted or personal best (if known)
4.Patients treated with fluticasone 500 µg + salmeterol 100 µg daily for = 4 weeks
5.A co-operative attitude and ability to correctly use the device and to complete the diary cards

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Inability to carry out pulmonary function testing;
2.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;
3.History of near fatal asthma;
4.Evidence of severe asthma exacerbation or symptomatic infection of the lower airways in the previous six months;
5.Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
6.Patients treated with long-acting ß2-agonists (LABAs) other than salmeterol, anticholinergics, and leukotriene antagonists during the previous 4 weeks;
7.Current smokers or recent (less than one year) ex-smokers defined as smoking at least 15 packs/year;
8.Clinically significant or unstable concurrent disease : e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; significant other pulmonary disease; cardiovascular disease; gastrointestinal disease; neurological disease; haematological disease, autoimmune disorders, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion;
9.Patients with a serum potassium value = 3.5 mEq/L
10.Patients with QTc interval (Bazett’s formula) higher than 450 msec at screening visit 1;
11.Cancer or any chronic diseases with prognosis < 2 years;
12.Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e. contraceptive methods other than oral contraceptives, IUD, tubal ligature). A pregnancy test in urine is to be carried out in women of a fertile age at screening
13.Significant alcohol consumption or drug abuse;
14.Patients treated with beta-blockers as regular use;
15.Patients treated with monoamine oxidase inhibitor, tricyclic antidepressants and Selective Serotonin Re-uptake Inhibitors (SSRIs), unless already taken at stable doses at the screening visit
16.Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
17.Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
18.Patients who received any investigational new drug within the last 12 weeks;
19.Patients with asthma exacerbations during the run-in period will also be excluded from the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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