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   43857   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:2010-023681-45
    Sponsor's Protocol Code Number:EndotoxinexpoIII
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-02-24
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-023681-45
    A.3Full title of the trial
    Endotoxin-induced immune response in the lower respiratory tract in smokers with and without chronic bronchitis (CB) and / or chronic obstructive pulmonary disease (COPD)
    Endotoxin-inducerad immunsvar i nedre luftvägar hos rökare med och utan kronisk bronkit (KB) respektive kroniskt obstruktiv lungsjukdom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Studies of induced immune responses in smokers
    Studie av inducerad immunsvar hos rökare
    A.4.1Sponsor's protocol code numberEndotoxinexpoIII
    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 SponsorVerksamhetsområde Geriatrik, Lungmedicin och Allergologi vid Sahlgrenska Universitetssjukhuset
    B.1.3.4CountrySweden
    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 supportVerksamhetsområde Geriatrik, Lungmedicin och Allergologi vid Sahlgrenska Universitetssjukhuset
    B.4.2CountrySweden
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEndotoxin
    D.3.2Product code E-solution
    D.3.4Pharmaceutical form Endotracheopulmonary instillation, powder for solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntrapulmonary use (Noncurrent)
    Endotracheopulmonary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNendotoxin
    D.3.9.1CAS number 11034-88-1
    D.3.10 Strength
    D.3.10.1Concentration unit ng nanogram(s)
    D.3.10.2Concentration typeequal
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeA well documented solution containing endotoxin from the cell wall of E. coli.
    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 placeboEndotracheopulmonary instillation
    D.8.4Route of administration of the placeboEndotracheopulmonary use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Airway inflammation in smokers with and without COPD and / or CB
    Luftvägsinflammation vid rökning hos individer med och utan KOL och/eller KB
    E.1.1.1Medical condition in easily understood language
    Airway inflammation in smokers with and without COPD and / or CB
    Luftvägsinflammation vid rökning hos individer med och utan KOL och/eller KB
    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
    Analyse the immune response caused by local endotoxinexposure in the airways and blood of smokers with and without CB and / or COPD and to identify differences from healthy never-smokers
    Att kartlägga immunsvaret som orsakas av lokal endotoxinexponering i luftvägar och blod hos rökare med och utan KB respektive KOL och att identifiera skillnader gentemot friska aldrig-rökare
    E.2.2Secondary objectives of the trial
    To identify cellular and molecular targets for new drug treatment for chronic respiratory disease
    Att identifiera cellulära och molekylära mål för nya läkemedelsbehandling för kronisk luftvägssjukdom
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age 40-75,
    smokers / non smokers
    no regular medication (except birth control pills and antidepressants)
    no chronic disease other than CB or COPD
    informed consent
    BMI / weight
    ålder 40-75,
    rökare/icke rökare
    ingen regelbunden medicinering (förutom p-piller och antidepressiva läkemedel)
    ingen kronisk sjukdom förutom KB respektive KOL
    informerad samtycke
    BMI / vikt
    E.4Principal exclusion criteria
    asthma, atopy, eczema,
    cardiovascular disorders
    pregnancy,
    regular medication
    snuff, chewing tobacco
    current participation in other studies
    chronic disease other than COPD / CB
    BMI / weight
    diabetes
    allergic reaction against ketobemidone, midazolam or lidocaine
    astma, atopi, eksem,
    hjärtsjukdomar
    graviditet,
    regelbunden medicinering se ovan,
    snus, tuggtobak
    aktuellt deltagande i andra studier
    kronisk sjukdom förutom KOL/KB
    BMI/vikt
    diabetes
    Överkänslighet gentemot ketobemidon, midazolam eller lidokain
    E.5 End points
    E.5.1Primary end point(s)
    Cell content of the BAL fluid, changes in inflammtory cells and mediators in airways
    Cellhalt i BAL vätska, förändringar i inflammtoriska celler och mediatorer i luftvägar
    E.5.1.1Timepoint(s) of evaluation of this end point
    All samples will be analyzed immediately after bronchoscopy 1 and 2.
    Samtliga prover analyseras strax efter bronkoskopi 1 och 2.
    E.5.2Secondary end point(s)
    Changes in the inflammatory cells and the mediators the blood.
    Förändringar i inflammatoriska celler och mediatorer i blod
    E.5.2.1Timepoint(s) of evaluation of this end point
    All samples will be analyzed immediately after bronchoscopy 1 and 2.
    Samtliga prover analyseras strax efter bronkoskopi 1 och 2.
    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
    Study endotoxin induced inflammation of the lower respiratory tract and the blood of smokers with and without COPD and / or CB
    Studera endotoxinorsakad inflammation i nedre luftvägar och blod hos rökare med och utan KOL och/eller KB
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Patienterna / försökspersonerna är sin egen kontroll
    The patients / subjects are their own control
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Patienterna / försökspersonerna är sin egen kontroll
    The patients / subjects are their own control
    E.8.2.4Number of treatment arms in the trial1
    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 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
    Administration of study drug (IMP) is given as a single dose at visit 2. The patient / subject ends his participation in the study after 3rd visit.
    Administering av studieläkemedlet (IMP) ges som engångsdos på besök 2. Patienten/försökspersonen avslutar sitt deltagande i studien efter 3:e besöket.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    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 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.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    Women of childbearing age are controlled with pregnancy test before administration of study drug.
    Kvinnor i fertil ålder kontrolleras med graviditetstest innan administration av studieläkemedlet.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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)
    In accordance with clinical practice
    I enlighet med klinisk praxis
    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 Decision2012-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-05-04
    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-Tue Apr 23 20:39:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA