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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2014-001563-12
    Sponsor's Protocol Code Number:20142017
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-02-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-001563-12
    A.3Full title of the trial
    Efficacy of Single inhaler Maintenance And Reliever Therapy (SMART) with Spiromax® budesonide/formoterol versus fixed dose treatment with Diskus® fluticasone/salmeterol in COPD
    Effectiviteit van 'single inhaler maintenance and reliever therapy (SMART)' met het middel Spiromax® budesonide/formoterol versus behandeling met vaste dosis Diskus® fluticasone/salmeterol bij patiënten met een chronisch obstructieve longziekte (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Symptom-driven treatment with inhaled budesonide/formoterol versus fixed dose fluticasone/salmeterol in COPD
    Effectiviteit van 'symptoom-gestuurde behandeling met het middel Spiromax® budesonide/formoterol versus een vaste dosering Diskus® fluticasone/salmeterol in COPD.
    A.3.2Name or abbreviated title of the trial where available
    SMART versus fixed dose treatment in COPD
    SMART versus vaste dosis behandeling bij patienten met COPD
    A.4.1Sponsor's protocol code number20142017
    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 SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTEVA pharma
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Groningen
    B.5.2Functional name of contact pointMaarten van den Berge
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31503615260
    B.5.6E-mailm.van.den.berge@umcg.nl
    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 DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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 Seretide
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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
    Chronic obstructive pulmonary disease (COPD)
    Chronisch obstructieve longziekte (COPD)
    E.1.1.1Medical condition in easily understood language
    Chronic obstructive pulmonary disease (COPD)
    Pulmonary Emphysema
    Chronisch obstructieve longziekte (COPD)
    Longemfyseem
    "rek uit de longen"
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 investigate the whether symptom-driven maintenance and reliever treatment with Spiromax budesonide/fomoterol is more effective in improving the number of COPD exacerbations than fixed dose treatment with Diskus fluticasone/salmeterol in patients with COPD.
    Onderzoeken of symptoom-gestuurde behandeling met Spiromax budesonide/formoterol effectiever is om het aantal COPD exacerbaties te verminderen dan een vaste dosering Diskus fluticasone/salmeterol.
    E.2.2Secondary objectives of the trial
    To investigate the whether symptom-driven maintenance and reliever treatment with Spiromax budesonide/fomoterol is more effective than fixed dose treatment with Diskus fluticasone/salmeterol in patients with COPD with respect to improvement of the following secondary endparamegters:

    • Lung function (PEF, FEV1, FEV1/FVC, FVC, FEF25-75%, RV, TLC, RV/TLC, RV/TLC %predicted);
    • IOS measurements, R5, R10, R15, R20, R5-R20, Frez, X5, AX;
    • Questionnaires (inhaler device satisfaction [PASAPQ and FSI-10], side effects [ICQ], health status [CCQ and SGRQ] and CAT);
    • Changes in blood cell differential counts;
    • Changes in inflammatory cell counts and microbiome data in induced sputum (in a subset of patients);
    • Moderately severe and severe exacerbations analyzed separately;
    Onderzoeken of symptoom-gestuurde behandeling met Spiromax budesonide/formoterol effectiever is dan een vaste dosering Diskus fluticasone/salmeterol met betrekking tot de volgende secundaire eindparameters:

    • Longfunctie (PEF, FEV1, FEV1/FVC, FVC, FEF25-75%, RV, TLC, RV/TLC, RV/TLC %predicted);
    • IOS metingen: R5, R10, R15, R20, R5-R20, Frez, X5, AX;
    • Vragenlijsten (tevredenheid over type inhalator [PASAPQ en FSI-10 vragenlijst], bijwerkingen van inhalatiecorticosteroiden [ICQ], gezondheid en symptomen [CCQ, SGRQ en CAT]);
    • Ontstekingscellen in bloed;
    • Ontstekingscellen en microbioom data in geinduceerd sputum (in een subgroep);
    • Matig ernstige en ernstige COPD exacerbaties apart geanalyseerd;
    • Aantal pneumonieen;
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1.
    To investigate whether it is possible to better predict a favorable treatment response to ICS/LABA combination treatment in patients with COPD. To this end, we will analyze clinical data as well as GWAS in blood and genome-wide DNA methylation, mRNA and microRNA expression in brushed nasal epithelium.

    2.
    To investigate whether it is possible to predict which COPD patients are at risk of having an exacerbation or pneumoia. To this end, we will analyze clinical data as well as microbiome data in induced sputum, GWAS in blood and genome-wide DNA methylation, mRNA and microRNA expression in brushed nasal epithelium.
    1.
    Onderzoeken of het mogelijk is te voorspellen welke COPD patienten een goede respons hebben op behandeling met combinatietherapie met een inhalatiecorticosteroid en langwerkende beta-agonist. Hiertoe zullen klinische parameters en GWAS in blood en DNA methylatie, mRNA en microRNA expressie in neusepitheel onderzocht worden.

    2.
    Onderzoeken of het mogelijk het risico op een COPD exacerbatie of pneumonie te voorspellen in COPD. Hiertoe zullen klinische parameters en GWAS in blood en DNA methylatie, mRNA en microRNA expressie in neusepitheel onderzocht worden.
    E.3Principal inclusion criteria
    • Age between 18 and 80 years
    • Smoking history of > 10 pack years
    • COPD patients with an FEV1 < 80% predicted either or not using inhaled corticosteroids.
    • At least one COPD exacerbation for which oral prednisolone had to be prescribed during 2 years prior to inclusion in the study.

    • Leeftijd tussen 18 en 80 jaar
    • Rookhistorie van > 10 pack years
    • COPD patienten met een FEV1 < 80% van voorspeld welke wel of geen inhaled corticosteroiden gebruiken.
    • Ten minste 1 COPD exacerbatie voor welke orale prednisolon voorgeschreven moest worden gedurende 2 jaar voorafgaand aan inclusie binnen de studie.
    E.4Principal exclusion criteria
    • History of asthma.
    • Exacerbation or respiratory tract infection during the last 4 weeks prior to randomization.
    • Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
    a) Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
    b) Hormonal contraception (implantable, patch, oral, injectable).
    c) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
    d) Continuous abstinence.
    • Periodic abstinence (e.g. calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the reduction in number of exacerbations (moderately severe ad severe exacerbation combined).
    De primaire uitkomstmaat is de vermindering van het aantal COPD excerbaties (matig ernstig en ernstige exacerbaties gecombineerd).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline an after treatment period of 6 and 12 months.
    E.5.2Secondary end point(s)
    • Lung function (PEF, FEV1, FEV1/FVC, FVC, FEF25-75%, RV, TLC, RV/TLC, RV/TLC %predicted);
    • IOS measurements, R5, R20, R5-R20, X5, AX;
    • Questionnaires (inhaler device satisfaction [PASAPQ and FSI-10], side effects [ICQ], health status [CCQ and SGRQ] and CAT);
    • Change of the lung microbiome in induced sputum (in a subset of patients);
    • Moderately severe and severe exacerbations analyzed separately;
    • Analysis of baseline clinical and targeted as well as genome-wide gene-expression data to identify predictors for a favorable ICS treatment response in COPD.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline an after treatment period of 6 and 12 months.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    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 trial2
    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 concerned6
    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 Yes
    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
    Last visit of the last subject.
    Laatste bezoek van de laatste persoon in de studie.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 260
    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 state260
    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
    Geen
    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 Decision2015-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-09
    P. End of Trial
    P.End of Trial StatusOngoing
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