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    Summary
    EudraCT Number:2013-004041-17
    Sponsor's Protocol Code Number:XEN-D0501-CL-05
    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:2013-11-07
    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 number2013-004041-17
    A.3Full title of the trial
    A double-blind, randomised, placebo-controlled, crossover study to assess the efficacy of XEN-D0501, a TRPV1 antagonist, in reducing the frequency of cough in patients with chronic obstructive pulmonary disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to determine whether the medical product XEN-D0501 reduces the frequency of coughing in patients with chronic lung disease (chronic obstructive pulmonary disease).
    A.4.1Sponsor's protocol code numberXEN-D0501-CL-05
    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 SponsorXention Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportXention Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationXention Limited
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressIconix Park
    B.5.3.2Town/ cityPampisford, Cambridge
    B.5.3.3Post codeCB22 3EG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+ 441223493900
    B.5.5Fax number+ 44 1223493901
    B.5.6E-mailinfo@xention.com
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXEN-D0501
    D.3.2Product code XEN-D0501
    D.3.4Pharmaceutical form Tablet
    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 INNNon
    D.3.9.1CAS number Non
    D.3.9.2Current sponsor codeXEN-D0501
    D.3.9.3Other descriptive nameBAY 69-9426
    D.3.9.4EV Substance CodeSUB31588
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboTablet
    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
    Chronic Obstructive Pulmonary Disease.
    E.1.1.1Medical condition in easily understood language
    A chronic lung disease in which patients cough, produce mucous and suffer from breathlessness.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    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
    To evaluate the effectiveness of XEN-D0501 over placebo in reducing objective daytime cough frequency.
    E.2.2Secondary objectives of the trial
    • To evaluate the effectiveness of XEN-D0501 over placebo in reducing:
    o capsaicin cough responses,
    o objective 24-hour cough frequency,
    o hourly change in cough frequency,
    o cough severity (via visual analogue scale (VAS)).
    o urge to cough (via VAS),
    o global rating of change scale,
    o Clinical COPD Questionnaire (CCQ),
    o Leicester Cough Questionnaire (LCQ),
    o St George's Respiratory Questionnaire (SGRQ-C)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients aged 40 years or over with COPD, defined as:
    • Smoking history of >10 pack-years,
    • A post-bronchodilator forced expiratory volume in 1 second (FEV1) <80% of the predicted normal value and a ratio between FEV1 and forced vital capacity (FVC) <0.7 after 4 puffs (4 x 100 μg) of salbutamol (via pressurized metered-dose inhaler [pMDI]).
    2. Day time cough frequency >1.5 coughs/hour (from 24-hour cough monitor at Visit 3),
    3. For patients recruited to the Capsaicin Challenge Cohort only:
    - A pre-bronchodilator FEV1 of at least 1.0 L at Visit 1
    - Emax from capsaicin challenge >10 coughs (from challenge cough monitor at Visit 3)
    4. Women must be of non-child bearing potential.
    • Non-child bearing potential is defined as amenorrheic for at least 1 year AND, if aged under 60 years, have serum follicle stimulating hormone [FSH] level of at least 30 IU/L) or have undergone a hysterectomy or bilateral oophorectomy (tubal ligation is not acceptable). Women who are taking hormone replacement therapy (HRT) do not have to have FSH assessments, but the amenorrhea (before starting HRT) must have been naturally (spontaneously) occurring and have been accompanied by an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms).
    5. If female partners of male patients are of childbearing potential, the patient must be willing to use contraception (e.g. condoms plus spermicide) AND their female partner must also be using contraception (e.g. hormonal or intra-uterine device).
    This double contraception must be used from the first dose of study drug until at least 90 days after the last dose of study drug.
    6. Written informed consent.
    E.4Principal exclusion criteria
    1. Body Mass Index (BMI) >40 kg/m2,
    2. Current smokers or patients with urine cotinine greater or equal to 500 ng/mL,
    3. Ex-smoker of <6 months,
    4. Upper respiratory tract infection within the last 6 weeks prior to randomisation (Visit 4),
    5. COPD exacerbation requiring treatment within 6 weeks prior to randomisation (Visit 4),
    6. Evidence of active microbial respiratory infection defined as the presence of significant pathogenic bacteria on sputum culture (assessed by colony forming units) at Visit 1,
    7. Feverish illness within the last 1 week prior to randomisation (Visit 4),
    8. Concomitant medications which may influence cough e.g. opioids, gabapentin, pregabalin, amitriptyline, ACE inhibitors, and those drugs listed in section 9.8.3
    9. Use of systemic corticosteroids within 3 months of Visit 1,
    10. Patient with concomitant conditions which may influence the cough reflex or the patient’s ability to participate in the study e.g. diabetes, cerebrovascular disease, Parkinson’s disease. N.B. Patients with type 2 diabetes may be included if, in the opinion of the investigator, they are well controlled and have no history suggestive of autonomic neuropathy;
    11. History of drug or alcohol dependency or abuse within approximately the last year prior to Visit 1,
    12. Regular alcohol consumption; >21 units/week for males, or >14 units/week for females, during the study (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
    13. Any known allergy to the study drugs,
    14. Pregnant and/or lactating women,
    15. History or evidence of urinary retention, bladder outlet obstruction or benign prostatic hypertrophy,
    16. Any clinically significant abnormalities in haematology or clinical biochemistry tests prior to randomisation (Visit 4).
    17. Serum alanine transaminase (ALT), aspartate transaminase (AST) or gamma-glutamyl transpeptidase (GGT) greater than twice the upper limit of normal (ULN) at Visits 1 or 2,
    18. Total serum bilirubin >1.5x ULN at Visits 1 or 2,
    19. History of any kind of cancer within the last 5 years unless non-invasive, in remission and approved in writing by Sponsor,
    20. COPD with respiratory failure that requires long term oxygen therapy,
    21. Evidence of any other clinically significant disease or condition which in the opinion of the investigator would preclude the patient’s participation in this study,
    22. QTcF value at Visit 1 (mean) or Visit 2 of >450 msec (males) or >470 msec (females)
    23. Patients with uncontrolled hypertension, systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at Visit 1 (mean) or Visit 2.
    24. Received investigational or marketed products as part of any other clinical study within 30 days (or 5 half-lives whichever is longer) prior to Visit 1,
    25. Patient is unable or unwilling to co-operate with the study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline after 14-days treatment in objective daytime cough frequency on XEN-D0501 compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days
    E.5.2Secondary end point(s)
    Change from baseline after at the end of each treatment period for the following parameters:
    • Capsaicin cough response (Emax) - Capsaicin Challenge Cohort only
    • Objective 24-hour cough frequency
    • Clinical COPD Questionnaire
    • SGRQ-C
    • Leicester Cough Questionnaire
    The assessments at the end of each treatment period for:
    • Hourly change in cough frequency
    • Global rating of change scale
    Change from baseline over each treatment period for the following parameters:
    • Cough severity (VAS)
    • Urge to cough (VAS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 days
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 Information not present in EudraCT
    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 state25
    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 Decision2013-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-25
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