FACTO Study (Foster® As Complete Treatment Option)

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Salmeterol Xinafoate

Criteria

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.