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FACTO Study (Foster® As Complete Treatment Option) (FACTO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00901368
First Posted: May 13, 2009
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
  Purpose
Double blind, multinational, multicentre, randomised, 2 arm parallel group study

Condition Intervention Phase
Asthmatic Patients Drug: FOSTER Drug: Seretide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Pre-dose morning FEV1 measured at clinic visit 5 [ Time Frame: 12-week treatment ]

Secondary Outcome Measures:
  • FEV1 area under the curve (AUC) in the first hour post-dose measured at clinics at visit 2 and visit 5 [ Time Frame: 12-week treatment ]
  • Pulmonary function tests measured at clinics (FEV1,PEF, FVC, FEF25-75%) [ Time Frame: 12-week treatment ]
  • ACQ score at baseline and at the end of treatment period [ Time Frame: 12-week treatment ]
  • Use of rescue medication [ Time Frame: 12-week treatment ]
  • Number of patients with controlled or partly controlled asthma at clinic visits according to GINA guidelines revised version 2007 [ Time Frame: 12-week treatment ]
  • Days without asthma symptoms (%), days without use of rescue medication (%) and daily asthma symptoms' score from diary cards [ Time Frame: 12-week treatment ]
  • Pharmacoeconomic analyses assessing differences in direct medical costs (healthcare perspective) and in both direct healthcare and indirect costs (societal perspective). [ Time Frame: 12-week treatment ]
  • Adverse events and adverse drug reactions,ECG ,Vital signs, Haematology/blood chemistry tests, OUCC ratio in a in a subgroup of 15% of patients [ Time Frame: 12-week treatment ]

Enrollment: 431
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CHF1535 (beclometasone dipropionate plus formoterol, 400/24 µg daily)
Drug: FOSTER
CHF1535 (beclometasone dipropionate 100 µg plus formoterol 6 µg) pMDI aerosol via HFA-134a propellant 2 inhalations b.i.d. (daily dose 400 µg + 24µg)
Active Comparator: 2
Seretide® Diskus® (fluticasone plus salmeterol, 500/100 µg /daily)
Drug: Seretide
Fluticasone 250 µg + salmeterol 50 µg DPI (Seretide® Diskus®) 1 inhalation b.i.d. (daily dose 500+100 µg)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901368


Locations
France
Hôpital Nord
Marseille, France, 13015
Germany
Allergologie imUmkreis der Praxis Pneumologie
Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
Netherlands
Atrium Medisch Centrum Heerlen,
Heerlen, Netherlands, 6419 PC
Spain
Hospital Universitario La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Neil Barnes, MD Department ofRespiratory Medicine, London Chest Hospital, Barts& The London NHS Trust,Bonner Road, E2 9JX, London (UK)
  More Information

Additional Information:
Publications:
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT00901368     History of Changes
Other Study ID Numbers: CCD-0806-PR-0032
2008-003740-11 ( EudraCT Number )
First Submitted: May 12, 2009
First Posted: May 13, 2009
Last Update Posted: March 30, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Beclomethasone
Formoterol Fumarate
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids