FACTO Study (Foster® As Complete Treatment Option)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00901368
First received: May 12, 2009
Last updated: April 20, 2012
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Pulmonary function tests measured at clinics (FEV1,PEF, FVC, FEF25-75%) [ Time Frame: 12-week treatment ] [ Designated as safety issue: No ]
  • ACQ score at baseline and at the end of treatment period [ Time Frame: 12-week treatment ] [ Designated as safety issue: No ]
  • Use of rescue medication [ Time Frame: 12-week treatment ] [ Designated as safety issue: No ]
  • Number of patients with controlled or partly controlled asthma at clinic visits according to GINA guidelines revised version 2007 [ Time Frame: 12-week treatment ] [ Designated as safety issue: No ]
  • Days without asthma symptoms (%), days without use of rescue medication (%) and daily asthma symptoms' score from diary cards [ Time Frame: 12-week treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT00901368     History of Changes
Other Study ID Numbers: CCD-0806-PR-0032
Study First Received: May 12, 2009
Last Updated: April 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Comité Ético de Investigación Clínica
Netherlands: Medical Ethics Review Committee (METC)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Fluticasone, salmeterol drug combination
Formoterol
Salmeterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents

ClinicalTrials.gov processed this record on July 23, 2014