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    Summary
    EudraCT Number:2005-003713-32
    Sponsor's Protocol Code Number:A5641009
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-10-17
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-003713-32
    A.3Full title of the trial
    A phase II, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of UK-500,001 Dry Powder for Inhalation (DPI) in adults with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
    A.4.1Sponsor's protocol code numberA5641009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Kft.
    B.1.3.4CountryHungary
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameUK-500,001
    D.3.2Product code UK-500,001
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNot available
    D.3.9.2Current sponsor codeUK-500,001
    D.3.9.3Other descriptive namecis-2-(3,4-Difluorophenoxy)-5-fluoro-N-[4-(2- hydroxy-5-methylbenzamido)cyclohexyl] nicotinamide
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100, 400, 1000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 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).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10009033
    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 efficacy and safety/tolerability of UK-500,001 DPI in adults with moderate to severe COPD (Global initiative in Obstructive Lung Disease [GOLD] stage II/III).
    E.2.2Secondary objectives of the trial
    1. To explore the efficacious dose range for UK-500,001 DPI in COPD and provide information for a Phase IIb dose ranging.
    2. To evaluate the time course of response to UK-500,001 DPI.
    3. To evaluate the persistence of UK-500,001 DPI effects on lung function and symptoms for two weeks after stopping the drug.
    4. To evaluate the PK-PD relationship between dose and/or systemic UK-500,001 exposure vs. efficacy and/or safety/tolerability in COPD patients.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female patients between, and including, the ages of 40 and 80 years. Females need to be of either non-childbearing potential; or if of childbearing potential may be included providing they are using acceptable methods of contraception.
    2. Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD, 2003 revision) and who meet the following criteria for Stage II III disease: Patients must have a post-bronchodilator FEV1/FVC ratio < 0.7 and a post-bronchodilator FEV1 of 30 - 80% (inclusive) of the predicted value for age, height, race and sex using European Community for Coal and Steel (ECCS) standards, Luxembourg 1993. To qualify for randomization, these criteria must be met at screen and replicated during run in phase.
    3. Patients must have a smoking history of at least 10 pack years and meet one of the following criteria: 1) They are current smokers; or 2). They are ex smokers who have abstained from smoking for at least 6 months.
    Formula for pack-years cigarettes = (average number of cigarettes/day ÷ 20) x years of smoking.
    Formula for pack-years tobacco = ounces per week x 2/7 x years of smoking.
    4. Patients must have stable disease for at least 1 month prior to screening. During the screening and run-in phase patients must be able to manage disease symptoms adequately with short acting bronchodilators only [i.e. inhaled ipratropium bromide 2 actuations (20mg/actuation) QID administered from a MDI +/- salbutamol rescue medication up to a maximum of 8 actuations (100mg/actuation) daily], without reliance on other therapies including oral or inhaled corticosteroids, long acting bronchodilators, nebulizer therapy, theophylline or regular oxygen.
    5. Body Mass Index (BMI) < 35 kg/m2 and a total body weight >40 kg.
    6. Patients must be able to give informed written consent prior to entering the study.
    7. Patients must be willing and able to comply with scheduled visit and all study related procedures.
    E.4Principal exclusion criteria
    1. More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
    2. History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomization.
    3. History or presence of respiratory failure, cor pulmonale or right ventricular failure. 4. Patients with home oxygen therapy (either prn or long term oxygen therapy, LTOT).
    5. Any clearly documented history of adult asthma or other chronic respiratory disorders (e.g. bronchiectasis, pulmonary fibrosis, pneumoconiosis).
    6. Known previous diagnosis of HIV infection, hepatitis B or C carrier status or chronic active hepatitis of any etiology (specific screening is not required).
    7. History of cancer (other than cutaneous basal cell) in the previous 5 years.
    8. History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
    9. Active tuberculosis within the previous 2 years.
    10. History within the previous 6 months of:
    a) an epileptic seizure.
    b) poorly controlled Type 1 or Type 2 diabetes.
    c) acute hepatitis of any etiology.
    11. A major surgical operation within 1 month of screening.
    12. Screening systolic blood pressure < 90mmHg.
    13. ECG abnormalities at screening or randomization, including those listed below. The investigator will decide whether ECG abnormalities other than those listed are clinically significant and should exclude the patient from enrollment.
    a) Predominant heart rhythm other than normal sinus rhythm e.g. atrial fibrillation, atrial flutter, supraventricular tachycardia.
    b) Patients with pre randomization evidence of QTc prolongation (defined as >450 msec for men; >470 msec for women) are not eligible for randomization without Pfizer approval. This assessment is made by the investigator at the time of ECG collection.
    c) Atrioventricular (AV) block greater than first degree.
    d) Resting heart rate >100 or <40 bpm.
    e) Evidence of previous myocardial infarction or significant ischemic changes in the absence of clinical history consistent with these findings.
    14. History or evidence, based upon a complete medical history, full physical examination, posterior anterior chest X ray (within last 12 months), 12 lead resting ECG or clinical laboratory test results, of any other significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the conduct, safety or interpretation of results of this study. Patients with certain chronic conditions such as hypertension, thyroid disease, Type 1 or Type 2 diabetes, hypercholesterolemia, gastroesophageal reflux, or depression may be included in the study as long as the conditions are well controlled and medications relating to the condition are stable and would not be predicted to compromise safety or interfere with the tests and interpretations of this study.
    15. Female patients of childbearing potential who are unwilling or unable to use an acceptable method of contraception from screening until completion of follow-up procedures.
    16. Use of any investigational drug other than UK-500,001 during this study, or within 1 month prior to screening. Note: Prior exposure to a PDE4 inhibitor during a clinical study is permitted, as long as the patient completed PDE4 inhibitor dosing in the clinical study at least 1 month prior to screening.
    17. Use of any of the prohibited medications within the indicated time frame prior to the start of screening (see protocol Section 5.5 for details).
    18. History of severe drug induced hypersensitivity (i.e. anaphylaxis).
    19. Known lactose intolerance or contraindicated for rescue/maintenance medication.
    20. Pregnant or nursing females, or females intending to become pregnant during the course of the study.
    21. Donation or intent to donate blood, or blood components during the study or within 1 month after completion of the study.
    22. Evidence of alcohol or drug abuse or dependency (specific screening is not required).
    23. Inability to fill, and inhale correctly from, the single pin monodose capsule inhaler device for any reason.
    24. Inability to comprehend, or unwillingness to follow, the study requirements including attendance at out patient clinic visits and participation in laboratory testing as called for by the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in trough (prior to administration of study drug) FEV1 at Week 6.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-10-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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)
    See protocol. No difference from expected normal treatment of COPD.
    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 Decision2005-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-09-01
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