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    Summary
    EudraCT Number:2013-004719-32
    Sponsor's Protocol Code Number:FLT2504
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-07
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-004719-32
    A.3Full title of the trial
    A single (assessor) - blind, randomised, three-period, cross-over study to compare the safety of flutiform® pMDI, fluticasone pMDI and beclometasone Autohaler® in paediatric subjects aged 5 to less than 12 years with mild persistent asthma by means of knemometry.
    Et enkelt- (observatør) blindet, randomiseret, 3-perioders, overkrydsningsforsøg til sammenligning af sikkerhed af flutiform pMDI, fluticason pMDI og beclometason Autohaler® hos børn i alderen fra 5 til mindre end 12 år med mild vedvarende astma bestemt ved knemometri.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Short-term growth study in children with asthma treated with fluticasone propionate / formoterol spray (flutiform®).
    Undersøgelse af korttidsvækst hos børn med astma i behandling med fluticasonpropionat /formoterol spray (flutiform®).
    A.3.2Name or abbreviated title of the trial where available
    FLT2504
    FLT2504
    A.4.1Sponsor's protocol code numberFLT2504
    A.5.4Other Identifiers
    Name:noneNumber:none
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMundipharma Research Ltd
    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 supportMundipharma Research Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMundipharma Research Ltd
    B.5.2Functional name of contact pointEuropean Medical Operations
    B.5.3 Address:
    B.5.3.1Street AddressCambridge Science Park, Milton Road
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB4 0AB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441223 424900
    B.5.5Fax number00441223 425794
    B.5.6E-mailinfo@contact-clinical-trails.com
    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 flutiform
    D.2.1.1.2Name of the Marketing Authorisation holderNorpharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameflutiform pMDI 50ug/5ug
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation No
    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.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    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 INNFormoterol Fumarate Dihydrate
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE DIHYDRATE
    D.3.9.4EV Substance CodeSUB25660
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 pMDI 50ug
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation No
    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.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 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 Yes
    D.2.1.1.1Trade name Aerobec Autohaler ®
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Denmark A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameBeclometasone Autohaler® 50ug
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation No
    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 INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.3Other descriptive nameBELCOMETASONE DIPROPIONATE
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Mild persistent asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10003555
    E.1.2Term Asthma bronchial
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    •To compare the safety of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on overnight urinary free cortisol (corrected for creatinine).

    Exploratory Objectives:
    •To compare mean lower leg growth rates with flutiform pMDI 50/5 µg and fluticasone pMDI 50 µg versus beclometasone Autohaler 50 µg.

    •To compare the safety of flutiForm pMDI 50/5 µg and fluticasone pMDI 50 µg to beclometasone Autohaler 50 µg based on overnight urinary free cortisol (corrected for creatinine).

    •To compare the efficacy of flutiForm pMDI 50/5 µg, fluticasone pMDI 50 µg and beclometasone Autohaler 50 µg by means of FEV1, PEFR, rescue medication use, asthma exacerbations asthma symptoms and activity limitations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and Female subjects 5 to <12 years old. Female subjects must be pre-menarche to be eligible.
    2.Subjects must be pre-adolescent without any signs of puberty (acc. to Tanner scale).
    3.Subjects are in normal range for their age in height and weight. Weight and height measurements should fall within the percentile range 3-97-% of normal values for age according to Danish growth charts.
    4.Known history of mild intermittent or persistent reversible asthma for ≥ 3 months prior to the screening visit.
    5.Require:
    a.only inhaled SABA therapy (e.g. Bricanyl Turbuhaler) on an as required basis, and/or
    b.Regular non-ICS controller medications for asthma (e.g., cromones or leukotriene receptor antagonists) at a stable dose for ≥ 3 months prior to the screening visit.
    6.No ICS for >2 weeks prior to the screening visit.
    7.Demonstrates adequate spirometry technique and able to use a home PEFR meter.
    8.Demonstrated FEV1 of ≥ 80% predicted value at visit 1following appropriate withholding of asthma medications (if applicable) (no SABA use within 6 hours of the PFT).
    9.Demonstrated satisfactory technique in the use of the pMDI plus spacer and Autohaler devices.
    10.Must be continent of urine and willing to perform (with parental/guardian help) overnight urine collections.
    11.Willing and able to complete morning and evening PEFR measures with the help of a parent or guardian, if necessary, and attend all study visits.
    12.Willing and able to substitute pre-study prescribed inhaled asthma medication for the entire duration of the study with study medication.
    13.Written informed consent obtained as per national laws.

    Inclusion Criteria required following run-in:
    14.FEV1 within ≤20% of the visit 1 value following appropriate withholding of rescue medication (no Airomir Autohaler use within 6 hours of the PFT).
    15.Rescue medication use on ≤2 days during the last 7 days of the run in period.
    E.4Principal exclusion criteria
    1.Require medications other than inhaled SABAs and/or regular non-ICS controller medications (e.g., cromones or leukotriene receptor antagonists) to maintain asthma control.
    2.ICS use within ≤ 2 weeks prior to the screening visit.
    3.Any asthma exacerbation of any severity for at least 3 months prior to the screening visit.
    4.Any fracture in the leg to be measured by knemometry ≤6 months prior to the screening visit.
    5.Any metabolic disorders or other diseases that may impact on normal growth patterns.
    6.Near fatal or life-threatening asthma within the past year.
    7.Hospitalisation or an emergency visit for asthma within the past 6 months.
    8.History of oral or injectable corticosteroid medication ≤3 months prior to the screening visit.
    9.Evidence of a clinically unstable disease, as determined by medical history, clinical laboratory tests, and physical examination that, in the Investigator’s opinion, preclude entry into the study. “Clinically significant” is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
    10.No major surgery requiring general anesthesia for at least 3 months prior to the screening visit.
    11.No febrile illnesses with temperature > 39°C within a week of the screening visit.
    12.In the Investigator’s opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the screening visit.
    13.Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiectasis, tuberculosis).
    14.Subjects who have taken β- blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrythmics, or potent CYP 3A4 inhibitors such as ketoconazole within 1 week prior to the screening visit.
    15.Current use of medications, other than those allowed in the protocol.
    16.Current evidence of hypersensitivity or idiosyncratic reaction to test medications or components.
    17.Receipt of an Investigational medicinal product within 30 days of the screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    Mean lower leg growth rate during each period
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects randomised to receive one 1 of 3 possible treatment sequences outlined below:-
    1)Treatment A:-Flutiform 50/5ug(2 puffs bid) pMDI
    2)Treatment B:-Fluticasone 50ug(2 puffs bid) pMDI
    3)Treatment C:-Beclometasone 50ug(2 puff bid)

    Each Treatment Phase is 14 days, separated by 14 days for the wash-out period.

    Measurement of lower leg growth using the knemometer will be taken at each visit by an assessor who is blinded to the study treatment. Knemometry measurements at visits 1 to 7 taken at the same time (+/-1hour) on the same day of the week wherever possible, corresponding to the beginning and the end of each treatment or wash-out period.
    E.5.2Secondary end point(s)
    •Mean 12-hour urinary free cortisol (corrected for creatinine) during each period.
    •Spontaneously reported adverse events.
    •Mean FEV1 at clinic visits.
    •Mean daily PEFR during each period.
    •Days of rescue medication use during each period.
    •Number (%) of asthma exacerbations during each period.
    •Number (%) of asthma symptoms during each period.
    •Number % of subjects who experienced any activity limitation due to asthma during each period.
    •Study medication use (compliance) during treatment period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    •12-hour urinary free cortisol (corrected for creatinine) during each period - overnight urine collections at end of each treatment phase.
    •Spontaneously reported adverse events collected at during of study
    •FEV1 at clinic visits.
    •Daily PEFR during each period - morning & evening
    •Days of rescue medication use during each period.
    •Number (%) of asthma exacerbations during each period - day and evening
    •Number (%) of asthma symptoms during each period.
    •Number % of subjects who experienced any activity limitation due to asthma during each period.
    •Study medication use (compliance) during treatment period.

    Refer to protocol for full details
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    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.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    End of Trial is defined as the 'Last Visit Last Subject' - LVLS
    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 months6
    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 Yes
    F.1.1Number of subjects for this age range: 48
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 48
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 5-11yrs

    Informed consent by means of a patient information sheet (PIS) and Informed Consent Form (ICF) signed by subject guardian/legally authorised representative.

    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    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)
    None
    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 Decision2014-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-11
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