Clinical trial NCT00901368: FACTO Study (Foster® As Complete Treatment Option)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthmatic Patients
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 431
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Pre-dose morning FEV1 measured at clinic visit 5
timeFrame: 12-week treatment
Secondary outcomes:
measure: FEV1 area under the curve (AUC) in the first hour post-dose measured at clinics at visit 2 and visit 5
timeFrame: 12-week treatment
measure: Pulmonary function tests measured at clinics (FEV1,PEF, FVC, FEF25-75%)
timeFrame: 12-week treatment
measure: ACQ score at baseline and at the end of treatment period
timeFrame: 12-week treatment
measure: Use of rescue medication
timeFrame: 12-week treatment
measure: Number of patients with controlled or partly controlled asthma at clinic visits according to GINA guidelines revised version 2007
timeFrame: 12-week treatment
measure: Days without asthma symptoms (%), days without use of rescue medication (%) and daily asthma symptoms' score from diary cards
timeFrame: 12-week treatment
measure: Pharmacoeconomic analyses assessing differences in direct medical costs (healthcare perspective) and in both direct healthcare and indirect costs (societal perspective).
timeFrame: 12-week treatment
measure: Adverse events and adverse drug reactions,ECG ,Vital signs, Haematology/blood chemistry tests, OUCC ratio in a in a subgroup of 15% of patients
timeFrame: 12-week treatment
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Nord
city: Gelsenkirchen
country: Germany
facility: Allergologie imUmkreis der Praxis Pneumologie
state: Nordrhein-Westfalen
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum Heerlen,
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
affiliation: Department ofRespiratory Medicine, London Chest Hospital, Barts& The London NHS Trust,Bonner Road, E2 9JX, London (UK)
name: Neil Barnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes N, van Noord JA, Brindicci C, Lindemann L, Varoli G, Perpina M, Guastalla D, Casula D, Patel S, Chanez P; FACTO (Foster(R) As Complete Treatment Option) Study Group. Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination. Pulm Pharmacol Ther. 2013 Oct;26(5):555-61. doi: 10.1016/j.pupt.2013.01.011. Epub 2013 Mar 22.