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    Summary
    EudraCT Number:2016-004450-15
    Sponsor's Protocol Code Number:RPL554-CO-202
    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:2016-11-29
    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 number2016-004450-15
    A.3Full title of the trial
    A phase II, randomised, double blind, placebo controlled, three way crossover study to assess the bronchodilator effect of RPL554 administered in addition to open label tiotropium in patients with COPD.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of RPL554 in addition to tiotropium in COPD patients
    A.3.2Name or abbreviated title of the trial where available
    The effects of RPL554 in addition to tiotropium in COPD patients
    A.4.1Sponsor's protocol code numberRPL554-CO-202
    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 SponsorVerona Pharma plc
    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 supportVerona Pharma plc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVerona Pharma plc
    B.5.2Functional name of contact pointSuzanne Bosque
    B.5.3 Address:
    B.5.3.1Street AddressVerona Pharma plc, 3 More London Riverside,
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 2RE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)203 283 4200
    B.5.6E-mailSuzanne.Bosque@veronapharma.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 nameRPL554
    D.3.2Product code RPL554
    D.3.4Pharmaceutical form Nebuliser suspension
    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 INNRPL554
    D.3.9.1CAS number 298680-25-8
    D.3.9.2Current sponsor codeRPL554
    D.3.9.3Other descriptive nameRPL554
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 6
    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.IMP: 2
    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 Spiriva®
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 nameSpiriva®
    D.3.4Pharmaceutical form Capsule, hard
    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 INNTiotropium bromide monohydrate
    D.3.9.1CAS number 139404-48-1
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    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 placeboNebuliser 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
    Chronic obstructive pulmonary disease (COPD)
    E.1.1.1Medical condition in easily understood language
    COPD (a smoking related disease of the airways resulting in difficulty breathing)
    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 20.0
    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 investigate the bronchodilator (opening of the airways) effect on peak FEV1 (lung function) measured in first 4 hours after dosing and average FEV1 (lung function) over 12 hours of nebulised RPL554, dosed twice daily for 3 days (five total doses), as compared to placebo (dummy drug containing no active ingredient), when administered in addition to once daily tiotropium.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • To investigate the effect of twice daily nebulised doses of RPL554, as compared to placebo (dummy drug containing no active ingredient), when administered in addition to tiotropium on lung volumes
    • To assess the bronchodilator (opening of the airways) effect on peak FEV1 (lung volumes) (measured in first 4 hours after dosing) and average (measured as the area under the curve [AUC]) FEV1 over 12 hours of nebulised RPL554 after the first dose as compared to placebo, when administered in addition to tiotropium
    • To analyse plasma concentrations and assess the steady state pharmacokinetics (levels of study drug in the blood) of RPL554 when administered in addition to tiotropium
    • To assess the tolerability and safety of twice daily nebulised doses of RPL554 in addition to tiotropium
    • To assess the dose response of two different doses of RPL554 on peak, average (0 to 12 hours), and morning trough FEV1 on Day 3 when dosed in addition to tiotropium
    • To determine the
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
    2. Male or female aged between 40 and 75 years inclusive, at the time of informed consent.
    3. If male: must agree to meet the following from the first dose up to 2 months after the last dose of study treatment:
    • Not donate sperm
    • Either: be sexually abstinent in accordance with a patient’s usual and preferred lifestyle (but agree to abide by the contraception requirements below should their circumstances change)
    Or: use a condom with all sexual partners. If the partner is of childbearing potential the condom must be used with spermicide and a second highly effective form of contraception must also be used (as defined in Section 8.4)
    4. If female: either be:
    a) Of non-childbearing potential defined as being:
    • Either: post-menopausal (being spontaneously amenorrhoeic for at least 1 year with an appropriate clinical profile [e.g. age appropriate, history of vasomotor symptoms]
    • Or: permanently sterilised e.g. tubal occlusion, hysterectomy, bilateral oophorectomy, bilateral salpingectomy
    b) Of childbearing potential and agreeing to use a highly effective method of contraception (as defined in protocol section 8.4) until completion of the end of study visit.
    5. Have a 12-lead ECG recording at screening and randomisation (pre-dose in Treatment Period 1) showing the following:
    • Heart rate between 45 and 90 beats per minute (bpm)
    • QT interval corrected for heart rate using Fridericia’s formula (QTcF) ≤450 msec for males and ≤470 ms for females
    • QRS interval ≤120 msec
    • No clinically significant abnormalities (as judged by the Investigator) including morphology (e.g. left bundle branch block, atrio-ventricular nodal dysfunction, ST segment abnormalities)
    6. Have a screening Holter report with a minimum of 18 hours recording that is able to be evaluated for rhythm analysis which shows no abnormality which indicates a significant impairment of patient safety or which may significantly impairs interpretation in the opinion of the Investigator including:
    • Significant arrhythmias including atrial flutter, atrial fibrillation, ventricular tachycardia
    • Any symptomatic arrhythmia (except isolated extra systoles)
    • Any sustained second or third degree heart block
    7. Capable of complying with all study restrictions and procedures including ability to use the study nebuliser and HandiHaler® DPI correctly.
    8. Body mass index (BMI) between 18 and 33 kg/m2 (inclusive) with a minimum weight of 45 kg.
    9. COPD diagnosis: Patients with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli and MacNee, 2004) with symptoms compatible with COPD for at least 1 year prior to screening.
    10. Post-bronchodilator (four puffs of salbutamol) spirometry at screening:
    • Post-bronchodilator FEV1/FVC ratio of ≤0.70
    • Post-bronchodilator FEV1 ≥40 % and ≤80% of predicted normal
    • Demonstrates ≥150 mL increase from pre-bronchodilator FEV1
    11. Clinically stable COPD in the 4 weeks prior to screening and randomisation (pre-dose in Treatment Period 1).
    12. A chest X-ray (post-anterior) at screening, or in the 12 months prior to screening showing no abnormalities, which are both clinically significant and unrelated to COPD.
    13. Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
    14. Smoking history of ≥10 pack years.
    15. Capable of withdrawing from long acting bronchodilators for the duration of the study, and short acting bronchodilators for 8 hours prior to spirometry.
    E.4Principal exclusion criteria
    1. A history of life-threatening COPD exacerbation including Intensive Care Unit admission and/or requiring intubation.
    2. COPD exacerbation requiring oral steroids, or lower respiratory tract infection requiring antibiotics, in the 3 months prior to screening or randomisation (pre-dose in Treatment Period 1).
    3. A history of one or more hospitalisations for COPD in the 12 months prior to screening or randomisation (pre-dose in Treatment Period 1).
    4. Lactation (female patients only).
    5. Positive urine or serum pregnancy test at screening, or a positive urine pregnancy test prior to randomisation (female patients of childbearing potential only).
    6. Known hypersensitivity to RPL554 or its components.
    7. Intolerance or hypersensitivity to tiotropium.
    8. Evidence of cor pulmonale.
    9. Other respiratory disorders: Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnoea, known alpha-1 antitrypsin deficiency or other active pulmonary diseases.
    10. Previous lung resection or lung reduction surgery.
    11. Use of oral COPD medications (e.g. oral steroids, theophylline and romifulast) in the 3 months prior to screening or randomisation (pre-dose in Treatment Period 1).
    12. History of, or reason to believe, a patient has drug or alcohol abuse within the past 3 years.
    13. Inability to perform technically acceptable spirometry or whole body plethysmography (at screening or randomisation [pre-dose in Treatment Period 1])
    14. Received an experimental drug within 30 days or five half-lives, whichever is longer.
    15. Patients with a history of chronic uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, haematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant.
    16. Documented cardiovascular disease: arrhythmias, angina, recent or suspected myocardial infarction, congestive heart failure, a history of unstable, or uncontrolled hypertension, or has been diagnosed with hypertension in the 3 months prior to screening or randomisation.
    17. Concurrent use of non-cardioselective oral beta-blockers.
    18. Has had major surgery, (requiring general anaesthesia) in the 6 weeks prior to screening or randomisation (pre-dose in Treatment Period 1), or will not have fully recovered from surgery, or planned surgery through the end of the study.
    19. A disclosed history or one known to the Investigator, of significant non-compliance in previous investigational studies or with prescribed medications.
    20. Requires oxygen therapy, even on an occasional basis.
    21. Clinically significant prostatic hyperplasia (judged by the Investigator) or bladder-neck obstruction or with narrow-angle glaucoma.
    22. Any other reason that the Investigator considers makes the patient unsuitable to participate.
    E.5 End points
    E.5.1Primary end point(s)
    Peak FEV1 (measured in first 4 hours after dosing) and AUC0-12h FEV1. These will be measured after dosing on Day 3.

    The primary comparisons are RPL554 6mg + tiotropium vs RPL554 placebo + tiotropium, followed by RPL554 1.5 mg + tiotropium vs RPL554 placebo + tiotropium.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment Period 1, 2 and 3 (Day 3): Pre-dose and post-dose at 5, 15 and 30 minutes and 1, 1.5, 2, 4, 6, 8 and 12 hours.
    E.5.2Secondary end point(s)
    1. Determination of AUC0-4h FEV1 after morning dosing
    2. Peak FEV1 (measured in first 4 hours after dosing) and AUC0-12h FEV1. These will be measured after dosing on Day 1.
    3. Determination of onset of action (>10% increase in FEV1, from pre-first dose, censored at 120 minutes) on Day 1
    4. RV, FRC and sGaw at 1.25 hours after dosing on Day 2
    5. RPL554 steady state pharmacokinetics (AUC, Cmax, time to maximum concentration [tmax], half-life)
    Safety and tolerability:
    6a. Continuous monitoring of adverse events
    6b. Laboratory safety tests [haematology, biochemistry and urinalysis]
    6c. 12-lead ECG (including QTcF and heart rate), supine vital signs [blood pressure and pulse rate]
    6d. Peak (measured in first 4 hours after dosing) and AUC0-4h pulse rate for each treatment period.
    6e. Holter monitor results
    Exploratory Endpoints:
    7a. AUC0-24h FEV1 on Day 3
    7b. Pre-dose FEV1 on Day 3
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1 pre AM dose,5,15,30mins,1,1.5,2,4hrs post AM dose.Day 2 pre AM dose,15,30mins,1,2,3,4hrs post AM dose.Day 3 pre-dose,5,15,30mins,1,1.5,2,4hrs post dose
    2. Day 1 pre AM dose,5,15,30mins,1,1.5,2,4,6,8,12hrs post AM dose
    3. Day 1 pre AM dose,5,15,30mins,1,1.5,2hrs post AM dose
    4. Day 2 pre AM dose,1.25hrs post AM dose
    5. Day 3 pre-dose,5,30,45mins,1,1.5,2,4,8,12,15,24hrs post dose
    6a. Throughout
    6b. Screen,Day 4,EOS
    6c. Screen,Day 1-3 pre AM dose,Day 1;30mins,1,2,4,6,8,12hrs post dose,Day 2;30mins,1,2,3,4,12hrs post dose,Day 3;30mins,1,2,4,6,8,24hrs post dose,EOS
    6d. Day 1;30mins,1,2,4hrs post dose, Day 2;30mins,1,2,3,4hrs post dose,Day 3;30 mins,1,2,4hrs post dose
    6e. Screen,Day 2-3 (24hrs)
    7a. Day 3;pre-dose,5,15,30mins,1,1.5,2,4,6,8,12,15,24 hrs
    7b. Day 3 pre-dose
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    The end of the study is defined as the date of the last end of study visit of the last patient in the study.
    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 months3
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days9
    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: 20
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Medication will not be provided by the sponsor to study subjects at the end of the trial. The investigator will ensure that the subjects continue to receive the best available treatment once they have completed the study, referring them back to their GP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-24
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