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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2008-003740-11-FR |
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Date of registration:
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12/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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06/02/2009 |
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Target sample size:
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452 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003740-11 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Double dummy
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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France
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Germany
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Netherlands
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion 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
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 ß2-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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Asthma
MedDRA version: 9.1
Level: LLT
Classification code 10003553
Term: Asthma
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Intervention(s)
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Trade Name: Foster
Product Name: Foster 100/6 µg
Product Code: CHF 1535 pMDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 5534-09-8
Other descriptive name: BDP
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: Formoterol fumarate
CAS Number: 43229-80-7
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Pressurised inhalation, solution
Route of administration of the placebo: Inhalation use
Trade Name: Seretide Accuhaler 250/50
Product Name: Seretide Diskus/Accuhaler
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: SALMETEROL XINAFOATE
CAS Number: 94749083
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: FLUTICASONE PROPIONATE
CAS Number: 80474-14-02
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Inhalation powder, pre-dispensed
Route of administration of the placebo: Inhalation use
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Primary Outcome(s)
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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.
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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®.
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Primary end point(s): pre-dose morning FEV1 measured at clinic visit 5
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Secondary ID(s)
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2008-003740-11-ES
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CCD-0806-PR-0032
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 06/02/2009
Contact:
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