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    The EU Clinical Trials Register currently displays   39189   clinical trials with a EudraCT protocol, of which   6420   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2010-024219-15
    Sponsor's Protocol Code Number:A6631029
    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:2011-05-17
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2010-024219-15
    A.3Full title of the trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 study of the efficacy and safety of PH-797804 taken for 12 weeks in adults with COPD taking a background of salmeterol/fluticasone combination.
    A.4.1Sponsor's protocol code numberA6631029
    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 SponsorPfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, 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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    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 nameNot Applicable
    D.3.2Product code PH-797804
    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 INNNot Applicable
    D.3.9.2Current sponsor codePH-797804
    D.3.9.3Other descriptive nameNot Applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Chronic Obstructive Pulmonary Disease (COPD)
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD) is a condition primarily effecting patients of middle age to elderly which is thought to be caused by an abnormal response to inflammation in the lungs .
    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 13.1
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    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 efficacy and safety/tolerability of 12 weeks administration of PH-797804 in adults with moderate to severe COPD (GOLD stage II/III) on a background of salmeterol xinafoate/fluticasone propionate combination.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
    Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
    1. Male or female subjects between, and including, the ages of 40 and 80 years. Females must be of non-childbearing potential. Females of non-child-bearing potential will be defined as:
    • Females who have been amenorrheic for at least 2 years and have a serum FSH level >30 IU/L in the absence of hormone replacement therapy or have a documented hysterectomy and/or bilateral oophrectomy.
    2. Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease:
    • Subjects 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 or NHANES III standards. To qualify for randomization, these criteria must be met at Screening and replicated during run-in phase (see randomization criteria for details).
    3. Subjects must have a smoking history of at least 10 pack-years* 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.
    *Formula for pack-years:
    cigarettes = (average number of cigarettes/day ÷ 20) x years of smoking.
    tobacco = ounces per week x 2/7 x years of smoking.
    4. Subjects treated with LABA/ICS combination at a stable dose(s) approved for COPD for at least 1 month prior to screening.
    5. Subjects must have had stable disease for at least 1 month prior to screening. During the screening and run-in phase subjects must be able to manage disease symptoms adequately with SFC +/-salbutamol (albuterol) rescue medication (subjects should not use >10 actuations [100 µg/actuations] daily for more than 2 consecutive days), without reliance on other therapies including oral or additional inhaled corticosteroids, other long-acting bronchodilators, nebulizer therapy, theophylline or regular oxygen.
    6. Body Mass Index (BMI) <35 kg/m2 and a total body weight >40 kg.
    7. Subjects must be able to give informed, written consent prior to entering the study.
    8. Subjects must be willing and able to comply with scheduled visit and all study-related procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
    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. Subjects 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 (eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis).
    6. Known previous diagnosis of Hepatitis B or C or HIV infection (specific screening is not required).
    7. History of cancer (other than cutaneous basal cell) in the previous 5 years.
    8. Active or past history of GI hemorrhage of any etiology, peptic ulceration, erosive esophagitis, gastric outlet obstruction or inflammatory bowel disease.
    9. Regular use of aspirin at a dose greater than 325 mg/day.
    10. History within the previous 2 years of: myocardial infarction, cardiac arrhythmia (eg, 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).
    11. A family history of long QT syndrome.
    12. Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Deriviative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG).
    13. History within the previous 6 months of:
    • An epileptic seizure.
    • Poorly controlled Type 1 or Type 2 diabetes.
    • Acute hepatitis of any aetiology.
    14. Presenting with:
    • Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
    • Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0 (See Appendix 3 for details).
    • Any clinically significant active systemic or cutaneous infection including herpetic lesions.
    • Congestive heart failure requiring treatment New York Heart Association (NYHA) Class III-IV.
    15. A major surgical operation within 1 month of screening.
    16. 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 subject from enrolment if abnormality is considered to be clinically significant:
    • Subjects with pre-randomization evidence of QTcF prolongation at screening or baseline Week 0 (defined as >450 ms) are not eligible for randomization. This assessment is based on a confirmed mean of the triplicate ECG recordings and is made by the investigator at the time of ECG collection.
    • Predominant heart rhythm other than normal sinus rhythm eg, atrial fibrillation, atrial flutter, supraventricular tachycardia.
    • Atrioventricular (AV) block greater than first degree.
    • Resting heart rate >100 or <40 bpm.
    • Evidence of previous myocardial infarction in the absence of clinical history consistent with these findings.
    • Evidence of acute ischemia.
    17. 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. Subjects 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 providing the conditions are well controlled and medications prescribed to treat the condition are not prohibited, have been stable for the month prior to screening and would not be predicted to compromise safety or interfere with the tests and interpretations of this study.

    Please refer to the protocol for a full list of the principle exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Comparison between treatments in the change from baseline in pre-bronchodilator, trough (prior to administration of study medication and other back ground medications) forced expiratory volume in one second (FEV1) at Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    1. Change from baseline in pre-bronchodilator, trough FEV1, forced expiratory volume in 6
    seconds (FEV6), forced vital capacity (FVC) and inspiratory capacity (IC) at 2, 4, 6, 10
    and 12 weeks of therapy.
    2. Average change from baseline in pre-bronchodilator, trough FEV1, FEV6, FVC and IC
    over 12 weeks of therapy.
    3. Change from baseline in post-study drug, pre-bronchodilator (i.e. post-study drug minus
    pre study drug) FEV1, FEV6, FVC, and IC at week 0 and after 12 weeks of therapy.
    4. Change from baseline in post-bronchodilator minus pre bronchodilator FEV1, FEV6,
    FVC, and IC at week 0 and after 12 weeks of therapy.
    5. Change from baseline in dyspnea (BDI/TDI) at Weeks 2, 4, 6, 10 and 12.
    6. Change from baseline in COPD symptoms (EXACT-PRO) over 12 weeks of therapy.
    7. Rescue bronchodilator use (per daily diary) over 12 weeks of therapy.
    8. Change from baseline in CRQ-SAS at Weeks 2, 4, 6, 10 and 12.
    9. Global Impression of Change (Clinician & Patient) at Week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 0, 2, 4, 6, 10, 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 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 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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 trial4
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Czech Republic
    New Zealand
    South Africa
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    As per protocol
    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 months6
    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 months6
    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: 164
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 164
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 328
    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)
    Subjects would return to the standard of care and/or remain on Salmeterol Fluticasone Combination (SFC) after study completion. Study Drug PH-797804 will not be available after the study.
    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 Decision2011-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-25
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