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:2016-001435-13
    Sponsor's Protocol Code Number:CHUBX2014/22
    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:2016-06-17
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-001435-13
    A.3Full title of the trial
    Description of the ability to learn how to handle inhaler devices in COPD
    Etude descriptive de la capacité d’apprendre à utiliser des systèmes d’inhalation dans la bronchopneumopathie chronique obstructive
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Description of the ability to learn how to handle inhaler devices in COPD
    Etude descriptive de la capacité d’apprendre à utiliser des systèmes d’inhalation dans la bronchopneumopathie chronique obstructive
    A.3.2Name or abbreviated title of the trial where available
    INTUITIVE
    INTUITIVE
    A.4.1Sponsor's protocol code numberCHUBX2014/22
    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 SponsorCHU de Bordeaux
    B.1.3.4CountryFrance
    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 supportCHU de Bordeaux
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointREC
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number+33557821097
    B.5.5Fax number+33557824926
    B.5.6E-mailvincent.dejarnac@chu-bordeaux.fr
    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 Ultibro® Breezhaler® 110/50 μg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm
    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.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.4EV Substance CodeSUB07951MIG
    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 INNINDACATEROL
    D.3.9.1CAS number 312753-06-3
    D.3.9.4EV Substance CodeSUB30138
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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 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 Spiriva® Respimat® 2,5 μg
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL GmbH
    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.3.4Pharmaceutical form 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 INNTIOTROPIUM BROMIDE
    D.3.9.1CAS number 139404-48-1
    D.3.9.4EV Substance CodeSUB11095MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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® 500/50 μg
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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, pre-dispensed
    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 INNSALMETEROL
    D.3.9.1CAS number 89365-50-4
    D.3.9.4EV Substance CodeSUB10430MIG
    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
    D.3.9.1CAS number 90566-53-3
    D.3.9.4EV Substance CodeSUB07760MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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)
    Bronchopneumopathie chronique obstructive (BPCO)
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD)
    Bronchopneumopathie chronique obstructive (BPCO)
    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
    The main objective of this study is to describe the handling of inhaler devices (indacaterol-glycopyrronium Breezhaler®, tiotropium Respimat® and salmeterol-fluticasone Diskus®) in patients with COPD.
    Estimer la proportion de sujets présentant au moins une erreur majeure dans l’utilisation des systèmes d’inhalation indacatérol-glycopyrronium Breezhaler®, tiotropium Respimat® et salmétérol-fluticasone Diskus® chez des sujets atteints de BPCO. L’évaluation de la manipulation de ces dispositifs médicaux sera réalisée après 7 jours d’utilisation.
    E.2.2Secondary objectives of the trial
    - Describe, during the various recordings, for every inhalation system (indacaterol-glycopyrronium Breezhaler®, tiotropium Respimat® and salmeterol-fluticasone Diskus®) :
    . The proportion of subjects presenting at least an error independent from the inhalation system,
    . The proportion of subjects presenting at least a not major error,
    . the time necessary mean for the treatment auto-administration
    - Estimate the observance and the safety of use of every treatment,
    - Describe the evolution of the FEV1 in presence and in absence of critical errors for every treatment,
    - Estimate the perception of the efficiency and the satisfaction score of the patients for every treatment,
    - Estimate the preference of the patient between the 3 inhalers.
    - Décrire, lors des différents enregistrements, pour chaque système d’inhalation (indacatérol-glycopyrronium Breezhaler®, tiotropium Respimat® et salmétérol-fluticasone Diskus®) :
    • la proportion de sujets présentant au moins une erreur indépendante du système d’inhalation,
    • la proportion de sujets présentant au moins une erreur non majeure,
    • le temps moyen nécessaire pour l’auto-administration du traitement,
    - Evaluer l’observance et la sécurité d’emploi (événements et effets indésirables) de chaque traitement,
    - Décrire l’évolution du VEMS en présence et en absence d’erreurs critiques pour chaque traitement,
    - Evaluer la perception de l’efficacité et le score de satisfaction des patients pour chaque traitement,
    - Evaluer la préférence du patient entre les 3 inhalateurs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female aged more than 40 years,
    - Written informed consent,
    - Diagnosis of COPD according to international guidelines (GOLD 2012),
    - Social security or health insurance,
    - Women of childbearing potential with a very effective contraception according to the HAS recommendations.
    - Homme ou femme âgé(e) de 40 ans ou plus,
    - Ayant donné son consentement par écrit,
    - Diagnostic de BPCO selon les critères de GOLD 2012,
    - Affilié(e) ou bénéficiaire d’un régime de sécurité sociale,
    - Pour les femmes en capacité de procréer, moyen de contraception très efficace selon les recommandations HAS.
    E.4Principal exclusion criteria
    - Previous treatment with Breezhaler®, Diskus® or Respimat® or similar device,
    - QT ≥ 450 ms,
    - Contraindications to tiotropium: hypersensitivity to tiotropium,
    - Contraindications to indacatérol: hypersensitivity to indacatérol,
    - Contraindications to salmeterol: hypersensitivity to salmeterol,
    - Contraindications to fluticasone: hypersensitivity to fluticasone,
    - Contraindications to glycopyrronium: hypersensitivity to glycopyrronium,
    - COPD exacerbation within 6 weeks before inclusion,
    - Chronic psychiatric disease,
    - Medical condition that may affect handling of inhaler devices,
    - Subject deprived of his/her liberty,
    - Protected adult,
    - Subject in exclusion period related to another protocol,
    - Pregnant or breastfeeding woman.
    - Traitement antérieur par Respimat®, Diskus® ou Breezhaler® ou autre dispositif similaire,
    - Sujets ayant présenté une exacerbation de BPCO dans les 6 semaines précédant l’inclusion,
    - Sujets présentant des troubles psychiatriques,
    - Sujets présentant des troubles articulaires pouvant gêner la manipulation des systèmes d’inhalation,
    - QT ≥ 450 ms,
    - Contre-indication au tiotropium : hypersensibilité au bromure de tiotropium, à l'atropine ou à ses dérivés (ipratropium ou oxitropium),
    - Contre-indication à l’indacatérol : hypersensibilité à l’indacatérol,
    - Contre-indication au salmétérol : hypersensibilité au salmétérol,
    - Contre-indication au fluticasone : hypersensibilité au fluticasone,
    - Contre-indication au glycopyrronium : hypersensibilité au glycopyrronium,
    - Sujet privé de liberté par décision judiciaire ou administrative,
    - Majeur protégé par la loi,
    - Sujet en période d’exclusion relative par rapport à un autre protocole,
    - Femme enceinte ou allaitant.
    E.5 End points
    E.5.1Primary end point(s)
    Critical errors from standardized checklist
    Présence d’au moins une erreur majeure dans l’utilisation du système d’inhalation, à partir d’une liste prédéfinie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days after the use of every inhaler
    7 jours après l'utilisation de chaque inhalateur
    E.5.2Secondary end point(s)
    - Non critical errors from standardized checklist,
    - Non device-dependant errors from standardized checklist,
    - Time necessary for drug administration,
    - FEV1 at baseline and at day 7,
    - Patient satisfaction and efficacy questionnaire,
    - Compliance,
    - Safety.
    -Erreurs indépendantes du système d’inhalation, à partir d’une liste prédéfinie,
    - Erreurs non majeures, à partir d’une liste prédéfinie,
    - Temps d’auto-administration du traitement,
    - Evolution du VEMS au début et à la fin de chaque période de traitement,
    - Observance au traitement,
    - Sécurité d’emploi du traitement (événements et effets indésirables),
    - Score de satisfaction du patient vis-à-vis du système d’inhalation,
    - Perception de l’efficacité du traitement par le patient (i.e. score de confiance),
    - Préférence du patient entre les 3 inhalateurs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 days after the use of every inhaler
    7 jours après l'utilisation de chaque inhalateur
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Descriptive study comparing the use of 3 inhalers
    Etude descriptive comparant l'utilisation de 3 inhalateurs
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    Phone contact to the last subject undergoing the trial, 30 days after his last visit.
    Appel téléphonique au dernier patient inclus dans l'étude, 30 jours après sa dernière visite.
    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 months
    E.8.9.1In the Member State concerned days65
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    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 state30
    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
    Aucun
    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 Decision2016-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-08
    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 20:52:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA