Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2006-005998-21
    Sponsor's Protocol Code Number:SAM108037
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2006-005998-21
    A.3Full title of the trial
    A multicentre randomised, double-blind, parallel-group study to compare the salmeterol xinafoate/fluticasone propionate combination (Seretide® Diskus® 50/100) 50/100 micrograms one inhalation twice daily with fluticasone propionate (Flixotide® Diskus® 100) 100 micrograms one inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent moderate asthma.
    A.4.1Sponsor's protocol code numberSAM108037
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratoire GlaxoSmithKline
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Seretide® Diskus® 50/100 µg
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire GlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSeretide Diskus 50/100 µg/dose
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSalmeterol xinafoate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfluticasone propionate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Flixotide® Diskus® 100µg
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire GlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFlixotide Diskus 100 µg/dose
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfluticasone propionate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    adult with moderate persistent asthma
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that salmeterol xinafoate/fluticasone propionate combination 50/100µg Diskus® (SFC100) on inhalation twice daily (bd) is more effective than fluticasone propionate 100µg Diskus® (FP100) bd on morning PEF, in the initial maintenance therapy of asthma in patients with moderate persistent asthma for whom a rapid control of asthma is deemed essential.
    E.2.2Secondary objectives of the trial
    - to demonstrate that SFC100 bd is more effective than FP100 bd on FEV1
    - to compare SFC100 et FP100 on time to reach first week of asthma control
    - to demonstrate in a sub-group of patients, that SFC100 bd is more effective than FP100 bd, in reducing air trapping (sub-group CT scan)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CT scan sub-study
    A sub-group of patients will participate to the CT-scan sub-stuy. In these patient a CT scan and an evaluation of Lung Volume will be performed at Randomisation and at the end of the treatment. For the randomisation evaluation, the exams may be distant from the visit day of 2 to 3 days in order to allow the patient to first see his investigator and shedule the scan and the lung volumes. investigator should insist on the fact that treatment should not be begun before the evaluations. For the last evaluations, scan and lung volumes have to be sheduled 2 to 3 days before the last visit to the investigator in order to allow performing the exams before the end of treatment.
    E.3Principal inclusion criteria
    Inclusion criteria for entry into the run-in period
    1- Male or female adult aged ≥18 years
    2- A documented clinical history of asthma
    3- A documented diagnosis of asthma on lung function based on airway reversibility of ≥12% in the last 2 years or at visit 1 based on either FEV1 or PEF measured pre and post inhalation of 400µg salbutamol (possible to demonstrate at Visit 2 for subjects who failed to demonstrate at Visit 1)
    4- A diagnosis of moderate persistent asthma defined as
    - daily symptoms
    - daily rescue use
    5- Inhaled corticosteroid-naive or inhaled corticosteroid-free (i.e.; no inhaled corticosteroids for at least 12 weeks prior to Visit 1)
    6- Able to use the Mini-Wright peak flow meter
    7- Able to complete a DRC
    8- Able to use a Diskus® correctly
    9- Affiliated or a beneficiary of a social security category
    10- A female is eligible to enter and participate in the study if she is:
    a- of a non-child-bearing potential OR
    b- of child bearing potential but has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study

    Inclusion criteria for entry into the treatment period
    1- A diagnosis of moderate persistent asthma based on the DRC and defined as
    - daily syptoms
    - daily rescue use
    - and moderate to severe airflow limitation based on mean morning PEF between 60-80% predicted measured over the last 7 days of the run-in period on the DRC values
    2- Demonstrated reversibility ≥ 12% based on FEV1 or PEF measured pre and post-inhalation of 400 µg salbutamol for subjects who failed to demonstrate at Visit 1
    3- A subject must have completed 80% of assessments on the DRC the last 7 days of the run-in period
    4- For patients participating to the CT-scan sub-sudy only: if subject is of child bearing potential, a negative pregnancy urine test must be obtained.
    E.4Principal exclusion criteria
    Exclusion criteria for entry into the run-in period
    1-Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
    2- FEV1< 60% predicted
    3- Subjects who have participated in any study using an investigational drug during the previous 4 weeks prior to Visit 1
    4- Subjects who have an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to Visit 1
    5- Acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalization within 12 weeks of Visit 1 or at Visit 1
    6- Use of oral parenteral or depot corticosteroid within 6 months of Visit 1
    7- Use of long-acting inhaled beta2-agonist or oral beta2-agonist within 4 weeks of Visit 1
    8- Use of Anti-leucotrienes, including suppressors of leukotriene production and leukotriene antagonists or theophyllines within 4 weeks of Visit 1
    9- Known clinical or laboratory envidence of a serious uncontrolled disease (including serious psychological disorders) likely to interfere with the study
    10- Subjects with a known or suspected hypersensitivity to inhaled corticosteroids, beta2-agonists, or any components of the formulations (e.g. lactose)
    11- Subjects who use any medication that significantly inhibits the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketokonazole
    12- Sujects who have previously been randomised in this study
    13- Smoking history: smoker and former smoker subjects who have more than 5 pack years
    14- Subjet who is pregnant or lactating; Subjects should not be enrolled if they plan to become pregnant during the time of study participation (up to visit 5).

    Exclusion criteria for entry into the CT scan study
    1- For CT scan population only: Patients aged > 40 years
    2- For CT scan population only: current smoker or former smoker who has stopped smoking within the 6 months before visit 1

    Exclusion criteria for entry into the treatment period
    1- Change in asthma medication(excluding study rescue medication)
    2- Respiratory tract infection or exacerbation of asthma
    3- Use of oral, parenteral or depot corticosteroids
    4- Non-compliance with the completion of the DRC during the run-in
    5- Subject who is pregant or lactating. Subjects should not be enrolled if they plan to become pregnant during the time of study participation (up to visit 5).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as the change from baseline in mean morning PEF over weeks 5-12.
    Change from baseline in mean morning PEF over weeks 5-12 will be compared between treatment groups using an analysis of covariance (ANCOVA) with covariates of age, sex and baseline PEF.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned62
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state310
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the study subjects will use their own asthma medication as prescribed by the investigator
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-03-21
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 14:06:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA