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    Summary
    EudraCT Number:2005-006076-35
    Sponsor's Protocol Code Number:BS557
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-05-22
    Trial 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-006076-35
    A.3Full title of the trial
    A MULTICENTRE, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PARALLEL-GROUP STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE BETWEEN FLUTICASONE PROPIONATE, 125 OR 250 µg TWICE DAILY DELIVERED VIA pMDI (MERCK GENERICS) WITH REFERENCE FLUTICASONE PROPIONATE FORMULATIONS, 125 OR 250 µg TWICE DAILY ADMINISTERED FROM REFERENCE pMDI IN ADULTS WITH MILD TO MODERATE PERSISTENT ASTHMA WHO ARE INHALED CORTICOSTEROID NAÏVE OR SYMPTOMATIC DESPITE BEING ON LOW DOSE INHALED CORTICOSTEROID THERAPY (ATHENA study)
    A.3.2Name or abbreviated title of the trial where available
    ATHENA
    A.4.1Sponsor's protocol code numberBS557
    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 SponsorMerck Generics
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    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 nameFluticasone propionate
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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 number125
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic glucocorticosteroid
    D.IMP: 2
    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 Information not present in EudraCT
    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 nameFluticasone propionate
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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 number250
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic glucocorticosteroid
    D.IMP: 3
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Flixotide 125 micrograms Evohaler
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK Ltd trading as Allen & Hanburys
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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®
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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.3.9.1CAS number 80474-14-2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic glucocorticosteroid
    D.IMP: 4
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Flixotide 250 micrograms Evohaler
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK Ltd trading as Allen & Hanburys
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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®
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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.3.9.1CAS number 80474-14-2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic glucocorticosteroid
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPressurised inhalation, suspension
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPressurised inhalation, suspension
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10003555
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary aim of the study is to demonstrate the therapeutic equivalence of generic formulations of fluticasone propionate, 125 or 250 µg twice daily administered from pMDI (Merck Generics) with reference fluticasone propionate formulations, 125 or 250 µg twice daily administered from reference pMDI in adult patients with mild to moderate persistent asthma who are inhaled corticosteroid naïve or symptomatic despite being on low dose inhaled corticosteroid therapy.
    E.2.2Secondary objectives of the trial
    The secondary aim of the study is to evaluate safety and tolerability of the generic formulations in comparison with the reference formulations in terms of vital signs, routine haematology and biochemistry, 24-hour urinary free cortisol levels (expressed as cortisol:creatinine ratio), physical examination and adverse events (including oral candidiasis).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients will be eligible for enrolment into the study if all of the following criteria are met at the screening visit (Visit 1):

    1. Male and female patients aged 18 to 65 years (inclusive)
    2. Documented clinical history of reversible obstructive airways disease of at least 6 months duration at the time of the Visit 1 for patients already receiving a low dose of ICS (including documented evidence of a clinical improvement on treatment with anti-asthma medication, e.g. improvements in symptoms or lung function)
    OR
    Documented clinical history of reversible obstructive airways disease of at least 2 weeks duration at the time of the Visit 1 for patients who are ICS naïve
    3. Patients who are ICS naïve OR on current treatment with low dose ICS (≤ 400 µg/daily budesonide equivalent) for at least 4 weeks prior to Visit 1 (see appendix 2 of protocol for equivalent doses for other ICS)
    4. Female patients of childbearing potential must agree to use adequate contraception during their participation in the study and for a period of 4 weeks following their final administration of study treatments (acceptable methods of contraception include hormonal contraception (either in a depot or oral formulation at a stable dose for at least 3 months prior to the start of the treatment) or a barrier method (intrauterine device, diaphragm, combination of condom and spermicide) or an agreement to avoid becoming pregnant). A female of non-childbearing potential will be defined as one who has been postmenopausal for at least 24 months, has been surgically sterilised (i.e. tubal ligation) or had a hysterectomy prior to screening.
    5. Ability to correctly use the pMDI, with the aid of a spacer if necessary (however, the use/non-use of a spacer device must remain constant throughout the patient’s participation in the study)
    6. The patient’s written informed consent to participate in the study

    The following must be demonstrated after withholding use of short-acting β2-agonists for the preceding 4 hrs. If a patient fails to meet the washout criteria at the screening visit, another appointment should be made to obtain clinical spirometry data:

    7. FEV1 between 60% and 85% of the predicted value for their age, height and gender at screening, (refer to section 5.8.3.1.2 of protocol)
    Note: Patients must not enter the run-in period without meeting this criterion
    8. Reversibility: demonstrated by a ≥ 12% increase in FEV1 (with an absolute improvement in FEV1 of at least 200mL) ≥ 10 min and up to 15 minutes after inhalation of up to 400 µg salbutamol (Ventolin Evohaler®) via a spacer (refer to section 5.8.3.1.2 of protocol)
    Note: Patients with a study-qualifying FEV1 may enter the run-in period without having demonstrated reversibility. Reversibility can be determined at screening, during the run-in period or at the randomisation visit. At the investigator’s discretion, if a patient fails to meet the ≥ 12% threshold, the reversibility tests may be repeated as many times as necessary during this period. Once reversibility has been demonstrated the reversibility test should not be repeated.
    E.4Principal exclusion criteria
    Patients will be excluded from participation if any of the following apply at screening (Visit 1):
    1. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
    2. Concomitant severe diseases or diseases which the investigator believes are contraindications for the use of inhaled steroids or which may affect the study outcome measures (e.g. active pulmonary tuberculosis)
    3. Suffering from chronic obstructive pulmonary disease (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing variable impairment in lung function
    4. Hospitalisation for asthma in the 6 months preceding Visit 1
    5. Current or recent (within 3 months of Visit 1) systemic (oral, parenteral or depot) corticosteroid therapy or receipt of more than 3 short courses of systemic corticosteroid therapy in the preceding year
    6. Current or recent (within 3 months of Visit 1) use of long-acting β2-agonists (inhaled, oral or otherwise systemic)
    7. Current use of anticholinergics for the relief of asthma symptoms
    8. Asthma exacerbations or respiratory tract infection requiring antibiotic treatment during the past 6 weeks
    9. Known or suspected hypersensitivity to fluticasone or the excipients of either of the pMDIs
    10. Inability to perform lung functions tests
    11. Patients who are unlikely to be compliant, take their medication as directed, complete the diary and daily lung testing procedures or attend scheduled clinic visits.
    12. Evidence of current neoplastic or systemic disease or diagnosed tuberculosis
    13. Pregnant or lactating women
    14. Smokers (current or previous) with > 10 pack years
    15. Evidence of history of alcohol or drug abuse
    16. Participation in an investigational drug trial during 30 days preceding Visit 1
    17. Employees of Merck Generics or Omnicare Clinical Research Ltd.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy measure is morning peak expiratory flow rate (PEFR) recorded daily with the Vitalograph® 2110 PEF FEV Diary.

    The primary efficacy variable is defined as the mean change in morning PEFR from baseline, where the baseline value is defined as the average of the last 7 days of the run-in period (with day 7 being the day before the randomisation visit). All post- randomisation measurements will be used for calculating the post-baseline average.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.7.1Other trial design description
    Double-dummy
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    End of the trial is the last visit of the last subject
    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
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 443
    F.4.2.2In the whole clinical trial 608
    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 Decision2006-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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