Estudio Fase IV, multinacional, multicéntrico, doble ciego, doble simulación, randomizado, de grupos paralelos, controlado, sobre la combinación de dosis fijas de Dipropionato de Beclometasona 100 µg más Fumarato de Formoterol 6 µg pMDI con propelente HFA-134A (CHF1535, FOSTER®) versus Fluticasona 250 µg más Salmeterol 50 µg IPS (SERETIDE® DISKUS®) como tratamiento de mantenimiento de pacientes asmáticos controlados.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

Conditions: AsmaAsthma
MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

Registration Number: EUCTR2008-003740-11-ES

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 452

Inclusion Criteria

1.Written informed consent obtained
2.Adult male and female (equal to and between 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) greater than or equal to 80% predicted or personal best (if known)
4.Patients treated with fluticasone 500 µg + salmeterol 100 µg daily for greater than or equal to 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 Beta2-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 investigators opinion;
9.Patients with a serum potassium value below or equal to 3.5 mEq/L
10.Patients with QTc interval (Bazetts 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
Main Objective: To demonstrate the equivalence in terms of FEV1 between CHF1535 (beclometasone dipropionate plus formoterol, 400/24 µg daily) and an equipotent dose of Seretide® Diskus® (fluticasone plus salmeterol, 500/100 µg /daily) in asthmatic patients already controlled on fluticasone plus salmeterol, 500/100 µg /daily.;Secondary Objective: To evaluate the efficacy of the two treatments in terms of pulmonary function, use of rescue medication, maintaining asthma control, to evaluate the safety profile through adverse events (AEs) and adverse drug reactions (ADRs) reporting, overnight urinary cortisol-creatinine ratio (OUCC), vital signs, and to assess treatment costs trough a cost minimisation analysis, comparing the total asthma-related direct medical costs and indirect costs in patients allocated to CHF1535 or to Seretide® Diskus®.;Primary end point(s): pre-dose morning FEV1 measured at clinic visit 5

Secondary Outcome Measures