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    Summary
    EudraCT Number:2011-004031-31
    Sponsor's Protocol Code Number:RVH006
    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:2011-09-21
    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 number2011-004031-31
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of treatment with repeat doses of inhaled RV568 in patients with COPD.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety of repeat doses of RV568 in patients with COPD.
    A.4.1Sponsor's protocol code numberRVH006
    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 SponsorRespiVert Ltd
    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 supportRespiVert Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRespiVert Ltd
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressImperial College BioIncubator, Level 1 Bessemer Building, Imperial College
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW7 2BP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+447557261726
    B.5.5Fax number+44207594 1213
    B.5.6E-mailpaul@respivert.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 nameRV568
    D.3.2Product code RV568
    D.3.4Pharmaceutical form Inhalation 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.3.9.2Current sponsor codeRV568
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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 Yes
    D.3.11.13.1Other medicinal product typeRV568 is a potent inhibitor of p38 type alpha protein/Src family kinases. It is a chemical.
    D.IMP: 2
    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 nameRV568
    D.3.2Product code RV568
    D.3.4Pharmaceutical form Inhalation 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.3.9.2Current sponsor codeRV568
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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 Yes
    D.3.11.13.1Other medicinal product typeRV568 is a potent inhibitor of p38 type alpha protein/Src family kinases. It is a chemical.
    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 placeboInhalation 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
    Chronic obstructive pulmonary disease (COPD) - sometimes called smokers cough, chronic bronchitis or emphysema
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 safety and tolerability of repeat inhaled doses of RV568 for 14 days in patients with moderate to severe stable COPD.
    E.2.2Secondary objectives of the trial
    - To characterise the pharmacokinetic parameters of RV568 following repeat administration of inhaled RV568 for 14 days in patients with moderate to severe stable COPD.
    - To evaluate the effect of treatment with repeat inhaled doses of RV568 for 14 days on pharmacodynamic markers in patients with moderate to severe COPD.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged 40-75 years inclusive at the time of signing the informed consent.
    2. Capable of giving written informed consent.
    3. Patients with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines, with symptoms compatible with COPD for at least 1 year prior to screening.
    4. Patients who conform to the current severity classification for GOLD Stage II/III disease in terms of post-bronchodilator spirometry at screening:
    • Post-salbutamol FEV1/FVC ratio of ≤ 0.70.
    • Post-salbutamol FEV1 ≥ 40 % and ≤ 80 % of predicted normal values calculated using ECCS reference equations.
    5. Demonstrated ability to use the I-neb AAD system at screening.
    6. Patient is a current or previous smoker with a smoking history of ≥ 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent).
    E.4Principal exclusion criteria
    1. A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
    2. A history of > 1 hospitalisation for COPD in the previous 2 years prior to screening visit 1.
    3. Evidence of cor pulmonale, clinically significant pulmonary hypertension and chronic use of oxygen.
    4. Upper or lower respiratory tract infection, including exacerbation of COPD, within 6 weeks of screening.
    5. Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases or other active pulmonary diseases.
    6. Patients with a history of chronic disease including, but not limited to, sleep apnoea, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant.
    7. Previous lung resection or lung reduction surgery.
    8. Pregnant or nursing females.
    9. Any abnormal or clinically significant ECG or lab values that the Investigator considers would put the subject at risk through participation.
    10. A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody result, or positive test for HIV antibody at the screening visit (or within the 3 months prior to screening).
    11. Positive test for drugs of abuse at screening that cannot be satisfactorily explained by a prescription history (e.g., recent use of codeine tablets).
    12. History of alcohol abuse within the previous 6 months.
    13. Has had major surgery, (requiring general anesthesia) within 6 weeks before screening visit 2, or will not have fully recovered from surgery, or planned surgery through the end of the study.
    15. A disclosed history, or one known to the Investigator, of significant noncompliance in previous investigational studies or with prescribed medications.
    16. Allergy to any of the active or inactive ingredients in the study medication, or history of drug, or other allergy that, in the opinion of the Investigator or RespiVert medical monitor, would contraindicate their participation.
    17. Donation of blood in excess of 500 mL within a 3 month period prior to dosing, or if study participation would result in blood loss in excess of 500 mL in a 3 month period.
    18. Patient is mentally or legally incapacitated.
    19. Has any condition or are taking a medication that, in the opinion of the Investigator, would make participation not be in the best interest (i.e., compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
    20. Is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability: Adverse events (AEs), 12-lead electrocardiogram (ECG; including QTc(B), QT, QRS, PR and ventricular rate), vital signs (blood pressure and heart rate), clinical laboratory evaluations (haematology, clinical chemistry, urinalysis), spirometry (forced expiratory volume in 1 second, forced vital capacity and peak expiratory flow), mucus and cough monitoring and withdrawals for worsening COPD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs: Day -1 to Day 28 (follow-up)
    12-lead ECG: screening, Days 1 and 14 at pre-dose, 0.5, 1 and 4 h post-dose, Day 15 and Day 28
    Vital signs:screening, Days 1 and 14 at pre-dose, 0.5, 1 and 4 h post-dose, Day 15 and Day 28
    Clinical laboratory evaluations: screening, Day -1 and Day 28
    Spirometry: screening, pre-dose on Days 4, 7, 9 and 12, Days 1 and 14 at pre-dose, 10 minutes and 1, 4 and 24 h and Day 28
    Peak expiratory flow: daily from Day 1 to Day 14
    Mucus and cough monitoring: daily from Day 1 to Day 14
    Withdrawals for worsening COPD: from Day 1 to Day 28
    E.5.2Secondary end point(s)
    Derived pharmacokinetic parameters for RV568 including AUC(0-t), AUC(0-inf), Ctrough, Cmax, t1/2, Tmax, CL/F, accumulation ratio following single and repeat dosing.

    Plethysmography measures: IC, RV, FRC, TLC, SVC, TGV, plus airway resistance (Raw) and specific airway conductance (sGaw).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic parameters: Days 1 and 14 at pre-dose, 15, 30 and 45 minutes post-dose and 1, 2, 4, 6, 8, 10, 12 and 24 h post-dose, Day 2, Day 4 pre-dose, Day 7 at pre-dose and 1 and 2 h post-dose, Day 15, Day 21 and Day 28

    Plethysmography measures: screening, Day -1 and Day 14 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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.6Cross over No
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 completion of the last patient’s follow-up visit/final contact.
    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 days0
    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 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: 30
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.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)
    Following the study subjects will continue to receive their normal treatment according to what their doctor thinks best suits their needs
    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 Decision2011-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-24
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