FACTO Study (Foster® As Complete Treatment Option)

Chiesi

Status and phase: Completed; Phase 4

Conditions: Asthmatic Patients

Treatments: Drug: Seretide; Drug: FOSTER

Study type: Interventional

Funder types: Industry

Identifiers

NCT00901368

2008-003740-11 (EudraCT Number)

CCD-0806-PR-0032

Details and patient eligibility

About

Double blind, multinational, multicentre, randomised, 2 arm parallel group study

Full 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 control in patients adequately controlled with fluticasone plus salmeterol at the above mentioned daily dose.

Enrollment: 431 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Asthmatic patients will be enrolled at Visit 1 into the run-in period if they meet all of the following 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.

Exclusion criteria

Patients will not be enrolled at visit 1 into the run-in period if they meet any of the following 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 β2-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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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431 participants in 2 patient groups

1

Experimental group

Description:

CHF1535 (beclometasone dipropionate plus formoterol, 400/24 µg daily)

Treatment:

Drug: FOSTER

2

Active Comparator group

Description:

Seretide® Diskus® (fluticasone plus salmeterol, 500/100 µg /daily)

Treatment:

Drug: Seretide