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    Summary
    EudraCT Number:2010-024640-15
    Sponsor's Protocol Code Number:R17609102003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-05
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2010-024640-15
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled ‘Proof of Concept’ study of 12 week treatment with RBx 10017609 in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, double-blind, placebo-controlled ‘Proof of Concept’ study of 12 week treatment with RBx 10017609 in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
    A.3.2Name or abbreviated title of the trial where available
    RBx 10017609 tablets in COPD
    A.4.1Sponsor's protocol code numberR17609102003
    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 SponsorRanbaxy Laboratories Limited
    B.1.3.4CountryIndia
    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 supportRanbaxy Laboratories Limited
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRanbaxy Laboratories Limited
    B.5.2Functional name of contact pointDr Rajinder K. Jalali
    B.5.3 Address:
    B.5.3.1Street Address77-B, Sector 18, IFFCO Road
    B.5.3.2Town/ cityUdyog Vihar Industrial Area, Gurgaon, Haryana
    B.5.3.3Post code122015
    B.5.3.4CountryIndia
    B.5.4Telephone number00911244016858
    B.5.5Fax number00911244107000
    B.5.6E-mailrajinder.jalali@ranbaxy.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 nameRBx 10017609
    D.3.2Product code RBx 10017609
    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 INNRBx10017609
    D.3.9.2Current sponsor codeRBx10017609
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Moderate to severe chronic obstructive pulmonary disease.
    E.1.1.1Medical condition in easily understood language
    Chronic obstructive pulmonary disease
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the safety and tolerability of 12 week treatment with RBx 10017609 (200 mg BID) in subjects with moderate to severe COPD.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of 12 week treatment with RBx 10017609 (200 mg BID) with respect to change in the following parameters as compared to placebo in subjects with moderate to severe COPD:

    - Sputum neutrophil count (percentage)
    - FEV1
    - St. George’s Respiratory Questionnaire (SGRQ)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who have signed an informed consent consistent with ICH-GCP guidelines prior to participation in the trial at prescreening visit.

    2. Male or female subjects, aged ≥40 years. Female subjects should be of non-childbearing potential [post menopausal* or those who have undergone surgical sterility (hysterectomy/bilateral tubal ligation/ bilateral oophorectomy)].

    Sexually active male subjects should agree to use a medically accepted form of contraception (barrier method) or must have undergone vasectomy in the past and their partner should be either using a medically acceptable form of contraception (oral contraceptives, intrauterine contraceptive devices) or have undergone tubal ligation in the past.

    3. Subjects with clinical diagnosis of COPD as defined by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009 and who additionally have:

    - smoking history of at least 10 pack years** (current and former smokers)

    - post-bronchodilator FEV1 to FVC ratio of <0.70 at screening (Visit 2).

    - post-bronchodilator FEV1 of ≥30% and ≤70% of the predicted normal value at screening. Post-bronchodilator refers to within 15-30 min. of inhalation of 4x100 mcg of salbutamol delivered at mouth piece (Visit 2).

    *Menopause is defined as the time when there has been no menstrual period for 12 consecutive months and no other biological or physiological cause can be identified (diagnosed on the basis of age appropriateness and history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with FSH levels greater than 40 mIU/mL at screening.

    **Number of pack years = (number of cigarettes/bidis smoked per day x number of years smoked)/20.
    E.4Principal exclusion criteria
    1. Subjects with history of hypersensitivity to study medication / drugs of similar class or β2-agonists or any of the excipients contained in any of these formulations.

    2. Subjects with Body Mass Index (BMI) of <18 or >35 kg/m2 at screening (Visit 2).

    3. Pregnant* or nursing women or women of child bearing potential**.

    4. Subjects having alpha-1 antitrypsin deficiency.

    5. Subjects with history of asthma***.

    6. Subjects with active pulmonary tuberculosis, lung or any other malignancy, bronchiectasis, cystic fibrosis or pneumonia

    7. Subjects using inhaled corticosteroids (ICS) and unable to stop these during the screening/run-in period.

    8. Subjects who have received treatment with oral or parenteral glucocorticosteroids within 6 weeks of screening/run-in period or depot corticosteroids within 12 weeks of screening/run-in period.

    9. Subjects with history of COPD exacerbation requiring systemic glucocorticosteroids and/or antibiotics and/or hospitalization within 6 weeks of screening****(Visit 2).

    10. Subjects with history of respiratory tract infection within 6 weeks of screening visit (Visit 2).

    Subjects who develop a respiratory tract infection between pre-screening (Visit 1) and randomization (Visit 3) must discontinue from the trial but may be permitted to re-enroll at a later date once the inclusion/exclusion criteria have been met.

    11. Subjects with hypoxemia (SpO2 < 88% on room air).

    12. Subjects with significant disease(s), disorder(s) other than COPD that in the opinion of the Investigator may (i) put the subject at risk because of participation in the study or (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in the study.

    13. Subjects having arthritis/connective tissue disorder or any other joint disorder that in the opinion of the Investigator might interfere with the study evaluations

    14. Subjects with history of consistent abnormal fasting blood sugar (>250 mg/dl or 14 mmol/L) or HbA1c greater than 8% at screening (Visit 2).

    15. Subjects with family history of long QT syndrome.

    16. Subjects with clinically significant abnormal 12-lead ECG or QTc >450 milliseconds as calculated by Fridericia formula (QTc = QT/RR0.33).

    17. Subjects with history of any lung surgery (e.g., lung resection etc.).

    18. Subjects with conditions which, in the opinion of the Investigator, prevent subjects from performing spirometry (e.g., hemoptysis of unknown origin, recent eye surgery etc.).

    19. Subjects requiring assisted ventilation or subjects who regularly use daytime oxygen therapy for more than 1 hour per day.

    20. Subjects with clinically significant abnormal haematology, biochemistry, or urinalysis; all subjects with an SGOT (AST) or SGPT (ALT) >2 times ULN or total bilirubin or serum creatinine >1.2 times ULN (Visit 2).

    21. Subjects with a history of HIV or positive serology results for Hepatitis B or C in the past 3 months prior to screening (Visit 2).


    22. Subjects with history of habitual alcohol consumption exceeding an average weekly intake of >21 units for males and >14 units for females***** .

    23. Subjects with history of drug abuse.

    24. Subjects who have received live attenuated vaccination within 4 weeks prior to screening****** (Visit 2).

    25. Subjects who have received any other investigational drug within the last 3 months of screening visit (Visit 2).

    26. Subjects who have previously been randomized in this study or are currently participating in another study.

    27. Subjects who, in the opinion of the Investigator, are unable to perform spirometry/sputum induction procedures or complete the St. George’s Respiratory Questionnaire.

    *Pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).

    ** All women who are physiologically capable of becoming pregnant.

    ***History of asthma indicated by, but not limited to: (i) onset of respiratory symptoms suggestive of asthma prior to 40 years of age and (ii) a history of diagnosis of asthma. If the subject had an absolute eosinophil count > 600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition

    **** Once stable, these subjects may be reconsidered for the study.

    ***** 1 unit = 284 mL of beer; 25 mL of spirits or 125 mL of wine

    ****** The use of polysaccharide pneumococcal and hemophilus influenzae vaccines is permitted.
    E.5 End points
    E.5.1Primary end point(s)
    • To assess the safety and tolerability of 12 week treatment with RBx 10017609 (200 mg BID) in subjects with moderate to severe COPD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At weeks 0, 4, 8 and 12
    E.5.2Secondary end point(s)
    To assess the efficacy of 12 week treatment with RBx 10017609 (200mg BID) with respect to change in the following parameters compared to placebo in subjects with moderate to severe COPD:
    Sputum neutrophil count (percentage)
    FEV1
    St. George's Respiratory Questionnaire (SGRQ)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At weeks 0, 4, 8 and 12
    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 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 Yes
    E.6.13.1Other scope of the trial description
    "Proof of concept" trial
    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 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 trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    India
    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
    End of trial at the end of Q4 2013.
    This includes Query resolution, DB lock and sites close out visits.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 135
    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)
    Treatment of care following participation in the trial is the expected normal treatment for the condition.
    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 Decision2012-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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