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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   40977   clinical trials with a EudraCT protocol, of which   6698   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2017-000124-95
    Sponsor's Protocol Code Number:V1.0
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-000124-95
    A.3Full title of the trial
    Randomised Controlled Crossover Trial of Inhaled Furosemide for Dyspnoea Relief in Advanced Heart Failure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial into the relief of breathlessness in patients with heart failure by inhaling furosemide which is usually taken as a tablet or injection.
    A.3.2Name or abbreviated title of the trial where available
    INFOD-HF V1.0
    A.4.1Sponsor's protocol code numberV1.0
    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 of Oxford
    B.1.3.4CountryUnited Kingdom
    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 supportBritish Heart Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOxford Respiratory Trials Unit, University of Oxford
    B.5.2Functional name of contact pointHania Piotrowska
    B.5.3 Address:
    B.5.3.1Street AddressOxford Centre for Respiratory Medicine, Churchill Hospital
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 7LE
    B.5.4Telephone number01865225552
    B.5.6E-mailhania.piotrowska@ouh.nhs.uk
    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.2.1.1.1Trade name Furosemide
    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 nameFurosemide
    D.3.4Pharmaceutical form Nebuliser 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 INNFurosemide
    D.3.9.1CAS number 54-31-9
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboInjection
    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
    Advanced heart failure with reduced ejection fraction (less than or equal to 40%) with significant breathlessness that limits what they are able to do. MRC Dyspnoea Scale ≥2.
    E.1.1.1Medical condition in easily understood language
    Severely weak heart pump and breathlessness
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We want to determine whether inhaled furosemide relieves breathlessness in patients with heart failure. This is to test the benefit of adding inhaled furosemide to existing treatment in chronic heart failure.

    The principle research objective:
    Determine the effect of inhaled furosemide on breathlessness in patients with chronic heart failure
    E.2.2Secondary objectives of the trial
    To determine the effect of inhaled furosemide on different aspects (physical and emotional) of breathlessness in patients with advanced chronic heart failure.

    To determine the effect of inhaled furosemide on breathlessness with exercise.

    To the effect of inhaled furosemide on the blood biomarkers of heart failure.

    To assess the changes in health-related quality of life for patients with heart failure with inhaled furosemide.

    To assess anxiety, depression and fatigue in patients with heart failure and the correlate to their breathlessness ratings.

    To assess the affect of inhaled furosemide on activity levels.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Patient is willing and able to give informed consent for participation in the trial.
    2)Male or Female, aged 18 years or above. (There is no upper age limit although the investigator will ensure they have the capacity to understand, consent and have the ability to perform the studies required.)
    3)Diagnosed with heart failure more than 3 months ago.
    4)Diagnosed with heart failure with a documented reduced ejection fraction <40%
    5)Significant breathlessness that limits what they are able to do. MRC Dyspnoea Scale ≥2.
    6)In the Investigator's opinion, is able and willing to comply with all trial requirements.
    7)Female participants of child bearing potential must be willing to ensure that they use effective contraception during the period they are taking the IMP/placebo and for 48hours after Visit 5.
    8) Prescribed regular furosemide or bumetanide tablets for at least 1 month
    E.4Principal exclusion criteria
    1)Those unable to consent for themselves
    2)History of allergic reaction (hypersensitive) to furosemide and/or any of the other ingredients of furosemide or amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or co-trimoxazole
    3)Unplanned heart failure related hospital admission within the last month (unstable heart failure).
    4)Patients diagnosed with heart failure within the last 3 months (unstable heart failure)
    5)Individuals who are dehydrated or have significant symptomatic postural hypotension
    6)Significant renal impairment (eGFR <15) or anuric
    7)Potassium <3.0 or >5.9 or Sodium <130 or >150 over the preceding month prior the screening visit.
    8)Significant hepatic impairment/cirrhosis (Child-Pugh class C)
    9)Addison's disease
    10)Digitalis intoxication
    11)Porphyria
    12)Individuals who are immunocompromised
    13)Patient with life expectancy <6 months
    14)Co-existent history of significant chronic obstructive pulmonary disease or asthma or interstitial lung disease or nasal polyps
    15)Patients on inhaled B2 agonist therapy
    16)Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the patient’s ability to participate in the trial.
    17)Have participated in another research trial involving investigational product in the past 4 weeks.
    18)Female patients who are pregnant, lactating or planning pregnancy over the course of trial.
    E.5 End points
    E.5.1Primary end point(s)
    Visual analogue scale (VAS) ratings of 'air hunger (AH)' during experimentally induced breathlessness to determine the effect of inhaled furosemide on breathlessness in patients with chronic heart failure.

    The VAS is a 10cm line with one end marked as 'no breathlessness at all' and the other end marked as 'worst possible breathlessness.' The participant marks across the line to indicate the level of breathlessness experienced during a test that is designed to make participants feel breathless (air hunger).
    E.5.1.1Timepoint(s) of evaluation of this end point
    40 patients attending the hospital on 5 occasions. Visits 2-5 will be the timepoints of evaluation for the primary and secondary endpoints.
    E.5.2Secondary end point(s)
    - Total score on Dyspnoea 12 questionnaire.
    - Peak workload, heart rate, oxygen consumption at peak and at anaerobic threshold achieved during cardiopulmonary exercise testing (CPET)or the 6-minute walk test if participant cannot perform CPET. Severity of breathlessness during these exercise tests using the VAS and/or Borg.
    - Blood biomarkers of heart failure (BNP and NT-proBNP).
    - Minnesota Living with Heart Failure Questionnaire (MLHFQ).
    - Trait and State Anxiety Questionnaire, Center for Epidemiological Studies depression scale, Fatigue severity score.
    - Activity levels from wearable watch.
    E.5.2.1Timepoint(s) of evaluation of this end point
    40 patients attending the hospital on 5 occasions. Visits 2-5 will be the timepoints of evaluation for the primary and secondary endpoints.
    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 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 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 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.8.3 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    No treatment will be available after the trial. Once patients have completed the trial their on-going care will be devolved to the local care team.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-02
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