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    Summary
    EudraCT Number:2015-005507-89
    Sponsor's Protocol Code Number:191190
    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:2016-06-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-005507-89
    A.3Full title of the trial
    The pulmonary effect of bronchodilation on adult VSD patients with persistent or surgically corrected VSD
    Luftvejsudvidelses effekt på hjertelungefunktionen hos voksne født med ventrikel septum defekter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of airway dilation on heart and lung function in adult patients born with ventricular septal heart defects
    A.3.2Name or abbreviated title of the trial where available
    VENTI Trial
    A.4.1Sponsor's protocol code number191190
    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 SponsorDepartment of Cardio-Thoracic and Vascular Surgery, Aarhus University Hospital
    B.1.3.4CountryDenmark
    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 supportDanish Agency for Science, Technology and Innovation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University Hospital
    B.5.2Functional name of contact pointDepartment of Cardio-Thoracic and V
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Blvd. 99
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number004528128866
    B.5.6E-mailventi.trial@gmail.com
    D. IMP Identification
    D.IMP: 1
    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 Ventoline Inhalationsspray, suspension 0,1 mg/dosis
    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 nameVentoline
    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 INNSALBUTAMOL SULFATE
    D.3.9.1CAS number 51022-70-9
    D.3.9.3Other descriptive nameSALBUTAMOL SULFATE
    D.3.9.4EV Substance CodeSUB04303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation solution
    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
    E.1.1.1Medical condition in easily understood language
    Ventricular septal defects are defined as a hole in the heart wall between the two pumping chambers of the heart.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10047298
    E.1.2Term Ventricular septal defect
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall purpose of this study is to test whether β2-agonists will affect the cardiopulmonary exercise capacity of VSD-operated patients compared with un-operated VSD-patients and healthy age- and gender-matched controls
    E.2.2Secondary objectives of the trial
    Furthermore we will investigate if the β2-agonists will affect the pulmonary function and heart-rate-variability of VSD-operated patients compared with un-operated VSD-patients and healthy age- and gender-matched controls.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ≥18 years of age and legally competent to vouch for their own study participation.

    Informed and written consent for participation in this trial.

    Trial group 1: Surgically corrected for isolated VSD between 1990 and 1998 at Aarhus University Hospital.

    Trial group 2: Diagnosed with isolated VSD born between 1977 and 1998 without surgical or percutaneous closure.
    - Verified by Echocardiography within the last 4 years. If it is more than 4 it will be verified by our doctors as a systolic murmur or echocardiography.

    Trial group 3: 18-40 years, with no known medical records of heart and lung disease.

    Restrain from strenuous leg exercise 24 hours before inclusion.
    E.4Principal exclusion criteria
    Lack of medical record.

    Pregnancy.
    - Participants will be asked if they are using contraceptives and be told to continue this during the trial and for at least 30 hours (5 times T2) after their last visit. If they are not using spiral or valid contraceptives (contraceptive pills, implants, transdermal patches, vaginal ring or injections) one of our medical experts will judge if the participant is able to undergo the trial. They will likewise be informed to withstand from sexual intercourse during the trial until 30 hours after the second visit.

    Currently breastfeeding.

    Syndromes, such as Down’s.

    Mentally or physically incompetent to perform the ergometer bicycle test.

    Thyrotoxicosis.

    Pre-trial medical record of arrhythmias except right bundle branch block.

    Asthma or other known β2-responsive conditions.

    Coronary heart disease.

    Severe pulmonary disease.

    Diabetes.

    Use of the following medication: Xantin-derivates, steroids, diuretics, ipratropium.

    Allergy to the active ingredients of Ventoline: Salbutamolsulphate, benzalkoniumchloride
    E.5 End points
    E.5.1Primary end point(s)
    Peak minute ventilation (ml min-1)
    Peak exercise oxygen uptake (ml O2 kg-1 min-1)
    Peak workload
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last patient is scheduled to be included no later than september 30th 2017. After this data analysis will commence.
    E.5.2Secondary end point(s)
    Lung clearance index: LCI 2,5 - Scond - Sacin

    Plethymography: TLC, RV, FRCpleth, sRAW,

    Spirometry: FEV1 FVC, FEV1/FVC

    Diffusion capacity: DLCO, VA (alveolar volume),

    Impulse Oscillometry: Diff 5-20

    Heart-rate variability: HRV, mean RR interval, RMSSD, arrhythmias discovered

    E.5.2.1Timepoint(s) of evaluation of this end point
    Last patient is scheduled to be included no later than september 30th 2017. After this data analysis will commence.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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
    Further evaluation of the cause for lower cardiopulmonary function in VSD operated patients.
    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 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 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 Yes
    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 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
    Patient recruitment will end September 30th 2017. After this data analysis will commence. If the trial have not included the 90 participants as expected we extend the recruitment period and apply for permits from the legal departments.
    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 days
    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: 110
    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 Yes
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state110
    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 Decision2016-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-15
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