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    Summary
    EudraCT Number:2008-001396-30
    Sponsor's Protocol Code Number:A7881010
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-001396-30
    A.3Full title of the trial
    A PHASE 2A, DOUBLE BLIND (3RD PARTY OPEN), 4 WAY CROSS-OVER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY, TOLERATION AND EFFICACY OF SINGLE INHALED DOSES OF PF-00610355 IN MODERATE COPD PATIENTS
    A.4.1Sponsor's protocol code numberA7881010
    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 Ltd, Ramsgate Road, Sandwich, Kent, UK
    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 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 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 namePF-00610355
    D.3.4Pharmaceutical form Inhalation powder
    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.3.9.1CAS number 862541-45-5
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number184
    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 No
    D.3.11.8Extractive medicinal product No
    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 placeboInhalation powder
    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.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD
    patients.
    • To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD
    patients.
    E.2.2Secondary objectives of the trial
    • To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.
    • To investigate the exposure/response relationship of PF-00610355 versus β2-mediated extra pulmonary effects in COPD patients in conjunction with prior knowledge from HV and asthmatic population, specifically: heart rate, blood pressure, QTc, arrhythmias, plasma potassium and blood glucose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Male and/or female subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease:
    • Post-bronchodilator FEV1/ FVC ratio of <0.7, and a
    • Post bronchodilator FEV1 of 50-80% (inclusive) of predicted for age, height, sex and race.
    2. Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
    A BMI upper limit of 34.5 kg/m2 may be rounded down to 35.0 kg/m2 and will be acceptable for inclusion.
    3. Subjects must have a smoking history of at least 10 pack-years (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) and meet one of the following criteria:
    • They are current smokers, or
    • They are ex-smokers who have abstained from smoking for at least 6 months.
    4. Subjects must have stable disease for at least 1 month prior to screening. Subjects must be able to manage their symptoms adequately with short-acting bronchodilators only. (salbutamol as needed, maximum of 8 actuations (100 µg/actuation) daily).
    5. An informed consent document signed and dated by the subject.
    6. Subjects who are willing and able to comply with scheduled visits, treatment plan,
    laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Subjects having more than 2 exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
    2. Use of prescription or non-prescription drugs as follows:
    • Subjects on medication having a significant effect on cardiac rate, conduction system (including QT interval) or myocardial function.
    • Subjects on medication known to be cytochrome P-450 3A4 inhibitors (eg, antiinfective agents such as erythromycin, triazole anti-fungal agents, chloramphenicol and fluvoxamine) or cytochrome P-450 3A4 inducers (eg, phenobarbital and phenytoin).
    • Subjects on inhaled corticosteroids.
    3. Subjects on β-blockers.
    4. Subjects with uncontrolled hypertension. Stable hypertensive subjects are permitted but must remain on their anti-hypertensive medication through out the study and not change drug, regime or dose etc during the trial.
    5. History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
    6. History or presence of respiratory failure, cor pulmonale or right ventricular failure.
    7. Apart from COPD, any clearly documented history of adult asthma (onset of symptoms prior to the age of 40 years) or other chronic respiratory disorders (eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis).
    8. Abnormal 12-lead ECG including evidence of ischaemia, myocardial infarction,
    arrhythmia or QTc >430 msec for women/QTc >450 msec for men. (If QTc exceeds
    these limits, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject’s eligibility). Patients with familial long QT syndrome are also excluded.
    9. A resting pulse rate >100 bpm or <50 bpm.
    10. History within the previous year of: myocardial infarction, cardiac arrhythmia (eg, atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), cardiac insufficiency NYHA II-IV, left ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
    11. Subjects with poorly controlled type I or type II diabetes, as indicated by an HbA1c of 10% or greater. Stable diabetics will be allowed.
    12. Any of the following liver function test abnormalities:
    • Alanine amino transferase >1.5 x upper limit of normal (ULN).
    • Aspartate amino transferase >1.5 x ULN.
    • Alkaline phosphatase >1.2 x ULN.
    • Total bilirubin >1.5 x ULN.
    13. A ferritin level <lower limit of normal.
    14. A potassium level <lower limit of normal.
    15. Positive HBsAg, HBcAB or anti-hepatitis C virus serology.
    16. Use of any investigational drug within 3 months prior to dosing.
    17. History of severe drug induced hypersensitivity (ie, anaphylaxis).
    18. Known lactose intolerance or contraindicated for rescue/maintenance medication.
    19. A positive urine drug screen.
    20. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of spirits) within 6 months of screening.
    21. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
    22. Subjects with a known intolerance to lactose, salbutamol or any of the listed rescue medications.
    23. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
    24. Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
    25. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    1.PF-00610355 PK: AUCinf, AUClast, Tmax, Cmax, T½.
    2. Systemic safety: Maximal and weighted mean (AUEC) change from baseline over 24 hr post dose in heart rate (pulse rate), plasma potassium, blood glucose, blood pressure and QTc.
    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 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 No
    E.8.1.2Open Yes
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    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 months8
    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 months8
    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.1.3Elderly (>=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 Yes
    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 2008-07-03. Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2008-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-02
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