Status:
COMPLETED
FACTO Study (Foster® As Complete Treatment Option)
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthmatic Patients
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Double blind, multinational, multicentre, randomised, 2 arm parallel group study
Detailed Description
Aim of the present investigation is to demonstrate the clinical equivalence between fluticasone plus salmeterol 500/100 µg daily and an equipotent dose of CHF1535 in maintaining the same asthma contro...
Eligibility Criteria
Inclusion
- Asthmatic patients will be enrolled at Visit 1 into the run-in period if they meet all of the following criteria:
- Written informed consent obtained
- Adult male and female (≥18 and ≤65 years)
- 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)
- Patients treated with fluticasone 500 µg + salmeterol 100 µg daily for ≥ 4 weeks
- A co-operative attitude and ability to correctly use the device and to complete the diary cards.
Exclusion
- Patients will not be enrolled at visit 1 into the run-in period if they meet any of the following 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;
- History of near fatal asthma;
- Evidence of severe asthma exacerbation or symptomatic infection of the lower airways in the previous six months;
- Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
- Patients treated with long-acting β2-agonists (LABAs) other than salmeterol, anticholinergics, and leukotriene antagonists during the previous 4 weeks;
- Current smokers or recent (less than one year) ex-smokers defined as smoking at least 15 packs/year;
- 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;
- Patients with a serum potassium value ≤ 3.5 mEq/L
- Patients with QTc interval (Bazett's formula) higher than 450 msec at screening visit 1;
- Cancer or any chronic diseases with prognosis \< 2 years;
- 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
- Significant alcohol consumption or drug abuse;
- Patients treated with beta-blockers as regular use;
- 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
- 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 with asthma exacerbations during the run-in period will also be excluded from the study.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT00901368
Start Date
May 1 2009
End Date
December 1 2010
Last Update
March 30 2017
Active Locations (4)
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1
Hôpital Nord
Marseille, France, 13015
2
Allergologie imUmkreis der Praxis Pneumologie
Gelsenkirchen, North Rhine-Westphalia, Germany, 45879
3
Atrium Medisch Centrum Heerlen,
Heerlen, Netherlands, 6419 PC
4
Hospital Universitario La Fe
Valencia, Spain, 46009