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    Summary
    EudraCT Number:2012-005035-85
    Sponsor's Protocol Code Number:2012RC14
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-05-13
    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 number2012-005035-85
    A.3Full title of the trial
    A proof of concept study in allergic rhinitis, to evaluate the differential effects of doxazosin between single and chronic dosing on nasal airway calibre
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Alpha-Blockers in Allergic Rhinitis
    A.3.2Name or abbreviated title of the trial where available
    MAN01 Alpha Blockers in Allergic Rhinitis Version 2.0
    A.4.1Sponsor's protocol code number2012RC14
    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 SponsorTayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside
    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 supportUniversity of Dundee and Wellcome Trust Translational Medical Research Fund
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAsthma and Allergy Research Group
    B.5.2Functional name of contact pointArvind Manoharan
    B.5.3 Address:
    B.5.3.1Street AddressNinewells Hospital
    B.5.3.2Town/ cityDundee
    B.5.3.3Post codeDD1 9SY
    B.5.4Telephone number01382383902
    B.5.5Fax number01382644972
    B.5.6E-maila.d.manoharan@dundee.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 Cardozin XL (doxazosin)
    D.2.1.1.2Name of the Marketing Authorisation holderArrow Generics Limited
    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.3.1Product nameDoxazosin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDoxazosin mesilate
    D.3.9.1CAS number 77883-43-3
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4mg
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allergic Rhinitis
    E.1.1.1Medical condition in easily understood language
    Allergic inflammation of the nose
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    What are the effects of chronic alpha blocker use on nasal blockage in patients with allergic rhinitis(allergic inflammation of the nose)?
    E.2.2Secondary objectives of the trial
    Assessing the effects of chronic alpha blocker use in terms of the response to nasal decongestants and nasal hyperreactivity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Able to provide informed consent Able to comply with the requirements of the protocol Diagnosis of allergic rhinitis Ability to tolerate Doxazosin XL 4mg without clinically significant drop in blood pressure Peak nasal inspiratory flow which is reversible to more than 20 l/min with oxymetazoline Positive skin prick test to at least 1 common aeroallergen Ability to withhold antihistamines for duration of the study Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s well being
    E.4Principal exclusion criteria
    Pregnancy, planned pregnancy or lactation Respiratory tract infection in the previous 2 months Nasal polyps of more than Grade 1 on nasal endoscopy Any known adverse reaction to the Investigational Medicinal Product or other quinazolines Known hepatic dysfunction (as no safety data available for this) Systolic blood pressure <100mmHg Any degree of heart block Any clinically significant medical condition that may endanger the health or safety of the participant or jeopardise the protocol Participation within another trial within the last 30 days Under the age of 18 Benign hyperplasia, chronic urinary tract infections, bladder stones, overflow bladder, anuria or progressive renal failure History of oesophageal or gastrointestinal obstruction or decreased lumen diameter of the gastrointestinal tract. Concomitant use of PDE5 inhibitors (sildenafil etc.) Alpha antagonists - this is the medication under investigation Other cardiovascular medications including but not limited to: ACE inhibitors, Angiotensin II antagonists, Beta blockers, calcium channel blockers, diuretics, nitrates, phosphodiesterase type-5 inhibitors or other vasodilating medications – these in combination with doxazosin carry an increased risk of symptomatic hypotension Monoamine oxidase inhibitors (MAOIs) – antidepressant medication that can lead to significant hypotension in combination with alpha antagonists Anxiolytics and hypnotics - enhanced hypotensive and sedative effects when alpha-blockers given in combination with these. Methyldopa and levodopa – potential enhanced hypotensive effect with alpha antagonists Nasal corticosteroid spray – would confound study outcomes Oxymetazoline - this is used as an outcome of response in the study Antihistamines - the participants will be undergoing a histamine nasal challenge Sympathomimetics i.e. dopamine, ephedrine, epinephrine, metaraminol, methoxamine, phenylephrine- may reduce the effect of Doxazosin Any other medication, which in the opinion of the Investigator may put the participant at risk
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the change in peak nasal inspiratory flow from baseline after acute and chronic dosing of doxazosin compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline, 12 hours post acute (first) dosing and 3 to 5 weeks for the chronic dosing for each treatment period.
    E.5.2Secondary end point(s)
    Nasal histamine challenge Nasal airways resistance Nasal nitric oxide Oxymetazoline dose response curve Domiciliary peak nasal inspiratory flow measurements Juniper Rhinoconjunctivitis Quality of Life Questionnaire Total Nasal Symptoms 4 point scale Nasal blockage 10 point visual analogue scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline, 12 hours post acute (first) dosing and 3 to 5 weeks for the chronic dosing for each treatment period.
    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) 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.8.3 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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 16
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 16
    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)
    Any advice regarding change of medical therapies will be sent to the participant's General Practitioner for follow up.
    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 Decision2013-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-06-02
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