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    Summary
    EudraCT Number:2005-003938-18
    Sponsor's Protocol Code Number:BY217/M2-125
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-19
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-003938-18
    A.3Full title of the trial
    Effect of roflumilast on exacerbation rate in patients with COPD.
    A 52 weeks, double-blind study with 500 mcg roflumilast once daily versus placebo

    Efecto de roflumilast sobre la tasa de exacerbaciones en pacientes con EPOC.
    Un estudio doble ciego de 52 semanas, con 500 mg roflumilast una vez al día frente a placebo
    A.3.2Name or abbreviated title of the trial where available
    HERMES
    A.4.1Sponsor's protocol code numberBY217/M2-125
    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 SponsorALTANA Pharma AG
    B.1.3.4CountryGermany
    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 nameRoflumilast 500 µg tablet
    D.3.2Product code BY217
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRoflumilast
    D.3.9.1CAS number 162401-32-3
    D.3.9.2Current sponsor codeBYK20869
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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)

    Enfermedad Pulmonar Obstructiva Crónica (EPOC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level llt
    E.1.2Classification code 10010952
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of 500 mcg roflumilast once daily on exacerbation rate, pulmonary function, COPD symptoms, dyspnea, health related quality of life and health care resource use
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of roflumilast
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    · Written informed consent
    · Age ≥40 years
    · History of COPD for at least 12 months as defined in the ATS/ERS consensus statement (Standards for the Diagnosis and Management of patients with COPD, 2004) and chronic productive cough for 3 months in each of the 2 years prior to baseline visit V0 (if other causes of productive cough have been excluded)
    · FEV1/FVC ratio (post-bronchodilator) ≤ 70%
    · FEV1 (post-bronchodilator) ≤ 50% of predicted
    · At least one documented COPD exacerbation (as defined by the need for oral or parenteral glucocorticosteroid intake and/or hospitalization) within one year prior to study baseline visit V0
    · Not suffering from any concomitant disease that might interfere with study procedures or evaluation
    · Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 20 pack years
    · Availability of a chest x-ray or CT-scan dated a maximum of 6 months prior to study baseline visit V0 or willingness to have a chest x-ray or CT-scan performed at visit V0
    E.4Principal exclusion criteria
    · COPD exacerbation indicated by a treatment with oral or parenteral glucocorticosteroids and/or hospitalization not resolved at V0
    · Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis)
    · Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
    · Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
    · Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or post-menopausal > 1 year or who are not using any other method of contraception considered sufficiently reliable by the investigator in individual cases
    · Chronic gastrointestinal disorders associated with a history of recurrent gastrointestinal bleedings within the last 12 months preceding the baseline visit V0
    · Participation in another clinical study (use of investigational product) within 30 days preceding the baseline visit V0
    · Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
    · Use of disallowed drugs
    · Use of immunosuppressive medications within 4 weeks prior to baseline (e.g. cyclosporine, methotrexate, TNF alpha receptors or antibodies, gold, azothiaprine)
    · Known alpha-1-antitrypsin deficiency
    · Known infection with HIV and/or active hepatitis
    · Diagnosis, treatment, or remission of any cancer (other than basal cell carcinoma) within 5 years prior to study start,
    · Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray/CT-scans/ ECG) that are not related to COPD and that require further evaluation
    · Clinically relevant ECG findings (e.g. acute or recent myocardial infarction, clinically significant arrhythmia)
    · Alcohol or drug abuse
    · Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
    · Patients not able to follow study procedures e.g. language problems, psychological disorders
    · Suspected non-compliance
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Primary variable:
    · Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids per patient per year

    Key-secondary variable:
    · Mean change from baseline (V2) during the treatment period in post-bronchodilator FEV1

    Secondary variables: COPD exacerbations
    · Mean rate of all COPD exacerbations per patient per year
    · Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids per patient per year (excluding hospitalizations)
    · Mean rate of COPD exacerbations requiring hospitalization per patient per year
    · Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids per patient per year in the population of patients with post-bronchodilator FEV1<30% of predicted at V2
    · Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids per patient per year within the patient population with a mean cough score of ³ 2 and a mean sputum score of ≥ 2 in the week directly preceding randomization
    · Proportion of patients experiencing a COPD exacerbation
    · Time to first COPD exacerbation treated with oral or parenteral steroids
    · Time to first COPD exacerbation requiring hospitalization
    · Time to second COPD exacerbation treated with oral or parenteral steroids
    · Mean number of COPD exacerbation days
    · Mean number of hospitalization days

    Secondary variables: Spirometry parameters and others
    · Mean change from baseline (V2) after the treatment period in post-bronchodilator FEV1
    · Mean change from baseline (V2) during and after the treatment period in pre-bronchodilator FEV1
    · Mean change from baseline (V2) during and after the treatment period in spirometry parameters
    · Symptoms and use of rescue medication
    · Proportion of symptoms free days / rescue medication free days
    · Health care resource use
    · Transition Dyspnea Index Focal Scores (BDI/TDI)
    · EQ-5D

    Safety:
    · Adverse events
    · Changes in laboratory values
    · Changes in physical examination findings including body weight and electrocardiograms (ECG)
    · Changes in vital signs blood pressure (BP) and heart rate (HR)
    · 24 hour holter monitoring (at selected centers in the US, in a subset of patients)
    · Hemoccult (guaiac) testing
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 2006-01-19. 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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 1500
    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 Decision2006-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-04-29
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