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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-005615-26
    Sponsor's Protocol Code Number:P05365
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-13
    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 ConcernedGreece - EOF
    A.2EudraCT number2007-005615-26
    A.3Full title of the trial
    Safety of SCH 527123 in Subjects with Neutrophilic Asthma
    A.4.1Sponsor's protocol code numberP05365
    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 SponsorSchering-Plough Research Institute, a Division of Schering Corporation
    B.1.3.4CountryUnited States
    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 nameSCH 527123 monhydrate capsules
    D.3.2Product code SCH 527123
    D.3.4Pharmaceutical form Capsule*
    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.3.9.1CAS number 862464-58-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    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 placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neutrophilic Asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the safety of SCH 527123 in subjects with neutrophilic asthma
    E.2.2Secondary objectives of the trial
    Effect of treatment with SCH 527123 on sputum neutrophils, asthma symptoms, pulmonary function tests, quality of life, electrocardiograms, laboratory assessments and adverse events. PK of SCH 527123.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be 18 to ≥70 years of age, of either sex, and any race.

    2. Subject must have an induced sputum neutrophil count ≥40% of total WBCs and <10 million/mL at Screening (Visit 1 assessment).

    3. Subject must have a documented diagnosis of asthma (within the past 5 years), which will be determined by at least one of the following: ≥12% and 200 mL improvement in FEV1 post-bronchodilator, and/or airway hyperresponsiveness (eg, positive methacholine challenge <8 mg/mL).

    4. Subject must be a nonsmoker or previous smoker with a cumulative smoking history of less than 20 pack years (pack-year = 20 cigarettes smoked daily for 1 year). Previous smokers may not have smoked within 1 year prior to Screening.

    5. Subject must not have had an exacerbation of asthma for the 4 weeks prior to Screening and subject must be on a stable medication regimen for asthma for at least 4 weeks prior to Screening.

    6. Subject must be receiving ≥800 mcg/day of beclomethasone dipropionate (BDP) or
    equivalent for at least 3 months prior to Screening (and on a stable dose for at least 4 weeks prior to Screening). Equivalent doses of ICS are defined as follows:

    DRUG MEDIUM DAILY DOSE (mcg) HIGH DAILY DOSE (mcg)
    Beclomethasone-CFC 500-1000 >1000
    Beclomethasone-HFA 250-500 >500
    Budesonide-DPI 600-1000 >1000
    Budesonide-Neb
    Inhalation Suspension 1000-2000 >2000
    Flunisolide 1000-2000 >2000
    Fluticasone 250-500 >500
    Mometasone Furoate 400-800 >800
    Triamcinolone acetonide 1000-2000 >2000

    7. Subject must be willing to give written informed consent to participate in the study.

    8. Subject must be capable of complying with the dosing regimen, adhere to the visit schedule, and participate in all treatment procedures, including sputum induction.

    9. A female subject of childbearing potential must have a negative serum pregnancy test (hCG)at Screening and must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate <1% per year when used consistently and correctly) prior to Screening and agree to continue using it while in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy. Female subject who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal. A female subject should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment.

    10. A male subject must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women who use a highly effective birth control method.

    E.4Principal exclusion criteria
    1. Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).

    2. Subject who has an upper or lower respiratory tract infection at Screening or has had one within 4 weeks prior to Screening.

    3. Subject who has received any of the following treatments more recently than the indicated washout period prior to Screening.

    Prohibited Medications Approximate Washout Period Prior to Screening
    Omalizumab 5 months
    Methotrexate, cyclosporine,
    gold, & other cytotoxic drugs 3 months
    Investigational drugs 30 days
    5-Lipooxygenase (5-LO)
    inhibitors (eg, Zileuton) 2 weeks
    Antibiotics 4 weeks
    Antiviral drugs 4 weeks

    4. Subject who produced an inadequate amount of sputum for evaluation at the Screening Visit (Visit 1) or is known to have difficulty producing sputum.

    5. Subjects with a total sputum neutrophil count of over 10 million/mL at the Screening Visit.

    6. Subjects with a PBN count of <3000/µL at the Screening Visit (Visit 1).

    7. Subject with a post-bronchodilator FEV1 <1L.

    8. Subjects with clinically significant chronic infectious disease(s) (eg, HIV, hepatitis B or C).

    9. Subject with allergy/sensitivity to the study drug or its excipients.

    10. Woman who is breast-feeding, pregnant, or intends to become pregnant during the study.

    11. Subject requiring mechanical ventilation for a respiratory event within 6 months of Screening.

    12. Subject with other clinically relevant medical condition(s) (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic) or who is using medication that may interfere with the effect of the study medication.

    13. Subject who has used any investigational drug within 30 days of Screening.

    14. Subject who is participating in any other clinical study.

    15. Subject who is part of the staff personnel directly involved with this study.

    16. Subject who is a family member of the investigational study staff.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is safety as defined by the proportion of subjects in each treatment group who maintain a peripheral blood neutrophil count ≥1500/µL during the 4-week treatment period.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 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.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 months6
    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 No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 30
    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 Decision2008-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-02-20
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