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    Summary
    EudraCT Number:2015-001468-21
    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:2015-09-15
    Trial results View 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 number2015-001468-21
    A.3Full title of the trial
    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
    Relief of breathlessness in heart failure patients by inhaling furosemide which is normally taken as a tablet or injection.
    A.3.2Name or abbreviated title of the trial where available
    Inhaled furosemide for dyspnoea relief in advanced heart failure
    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.1.3.4Country
    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 Brookes University
    B.5.2Functional name of contact pointJoanna Grogono
    B.5.3 Address:
    B.5.3.1Street AddressHealth and Life Sciences
    B.5.3.2Town/ cityOxford Brookes University
    B.5.3.3Post codeOX3 0BP
    B.5.4Telephone number+44 (0)1865 483257
    B.5.6E-mailjgrogono@brookes.ac.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 Yes
    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
    Advance heart failure - New York Class Association III-IV with ejection fraction <35%.
    E.1.1.1Medical condition in easily understood language
    Severely weak heart
    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 18.0
    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 explore whether inhaled furosemide relieves breathlessness in patients with heart failure. To address this question we first need to conduct a pilot study. This pilot study will inform a future clinical trial to test the benefit of adding inhaled furosemide to existing treatment in advanced heart failure patients.

    The principle research question:
    - What is the effect on inhaled furosemide on breathlessness in patients with chronic advanced heart failure?

    Why ask this question?
    Patients with heart failure often experience breathlessness/dyspnoea which restricts their activities. Furosemide is a prescription drug taken as a tablet or as an injection which makes kidneys produce more urine to remove fluid build-up in heart failure. Over time a third of patients will need more furosemide to get the same response from the kidneys but high level of furosemide can lead to kidney failure. If furosemide is inhaled instead this is known to stop coughing, protect the airwa
    E.2.2Secondary objectives of the trial
    To ensure that the most reliable future clinical trial the following factors will be addressed:
    i) assess how much furosemide gets absorbed from the lungs into the blood
    ii) determine the effect of inhaled furosemide on breathlessness with exercise
    iii) assess the effect of furosemide on blood tests which best monitor heart failure before and after exercise
    iv) Assess the effect of inhaling furosemide when applying different breathing patterns (shallow, fast breaths versus slow, deep breaths)
    Can the study answer it?
    At each visit the patients will
    i)have a blood test before and after the mist to see how much furosemide is absorbed into the blood
    ii)perform full cardiopulmonary exercise tests (cycle) or a 6-minute walk test
    iii)have a blood tests looking at markers of heart failure before and after mist inhalation and exercise
    iv) inhaled the mist with either fast, shallow breaths or slow, deep breaths. Each patient will do 2 visits with fast, shallow breaths (one with e
    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 it will be at the discretion of the investigator to ensure they have the capacity to understand, consent and have the ability to perform the studies required).
    3)Diagnosed with NYHA stage III or IV heart failure
    4)Treated with oral furosemide for at least 3 weeks
    5)Ambulatory and clinically stable in the previous 3 months
    6)Documented left ventricular ejection fraction (LVEF) of <35%.
    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)Individuals who are dehydrated or have significant symptomatic postural hypotension
    4)Significant renal impairment (eGFR <15) or anuric
    5)Significant hepatic impairment/cirrhosis (Child-Pugh class C)
    6)Addison's disease
    7)Digitalis intoxication
    8)Porphyria
    9)Individuals who are immunocompromised
    10)Patient with life expectancy <6 months
    11)Patients who are inappropriate for saline
    12)Co-existent history of significant chronic obstructive pulmonary disease or asthma or interstitial lung disease or nasal polyps
    13)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.
    14)Have participated in another research trial involving investigational product in the past 4 weeks.
    15)Patients who have had an admission to hospital with heart failure within the last 3 months
    16)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’during experimentally induced breathlessness with total score on Dyspnoea 12 questionnaire
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 patients completing 4 visits each, at least 1 week apart. Each patient will perform a breathlessness twice on each visit, once before and once after inhalation of the mist (furosemide or saline). A total of 8 breathlessness tests over the course of the study for each patient.
    E.5.2Secondary end point(s)
    i) to discover which breathing pattern should be used to inhale furosemide – fast, shallow or slow, deep breaths.
    ii) to find out how much furosemide gets absorbed from the lungs into the blood
    iii) to investigate whether full cardiopulmonary exercise tests can be used to monitor the benefit of inhaled furosemide in heart failure patients in place of usual 6-minute walk tests,
    iv) to discover which blood tests best monitor heart failure before and after inhaled furosemide
    v) to test whether experimentally induced breathlessness can be used to measure breathlessness sensitivity in heart failure patients rather than standard exercise tests.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 patients completing 4 visits each, at least 1 week apart. Each patient will perform a breathlessness test and an exercise test twice on each visit, once before and once after inhalation of the mist (furosemide or saline). A total of 8 breathlessness tests and 8 exercise tests over the course of the study for each patient. Each visit they will have 5 blood samples withdrawn from their cannula and their urine volume measured on two occasions after the mist inhalation.
    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.8.2.4Number 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days13
    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: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state12
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 12
    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 available after the trial. This is a preliminary trial and will lead onto a future clinical trial. Once patients have completed the trial their ongoing 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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-02
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