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    Summary
    EudraCT Number:2006-001248-30
    Sponsor's Protocol Code Number:XRP1526B/3031 Ciclesidone
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-18
    Trial 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 ConcernedEstonia - SAM
    A.2EudraCT number2006-001248-30
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ciclesonide metered-dose inhaler at a daily dose of 160 μg administered either in a once-daily in the morning regimen (160 μg qd AM) for 16 weeks or in a 160 μg qd AM regimen for 12 weeks preceded by a twice-daily regimen (80 μg bid) for 4 weeks, or in an 80 μg bid regimen for 16 weeks, in adults and adolescents with mild to moderate persistent asthma not treated with steroids.
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberXRP1526B/3031 Ciclesidone
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 SponsorSanofi-Aventis U.S. Inc.
    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 Information not present in EudraCT
    D.2.1.1.1Trade name ALVESCO
    D.2.1.1.2Name of the Marketing Authorisation holderAltana Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationEstonia
    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 nameciclesonide
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    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 INNciclesonide
    D.3.9.1CAS number 126544-47-6
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNciclesonide
    D.3.9.1CAS number 126544-47-6
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.3.11.13.1Other medicinal product typeinhaled corticostreroid
    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 placeboPressurised inhalation, solution
    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
    Asthma is a chronic inflammatory disease of the airways characterized by airway hyperresponsiveness, acute and chronic bronchoconstriction, airway edema, and mucus plugging. The inflammatory component of asthma is thought to involve many cell types including mast cells, eosinophils, T lymphocytes, neutrophils, and epithelial cells and their biologic products. Subjects with asthma most often present with symptoms of wheezing, shortness of breath, cough, and chest tightness.
    MedDRA Classification
    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 efficacy, compared to placebo, of ciclesonide at a daily dose of 160 μg administered either in a once-daily in the morning regimen (160 μg qd AM) for 16 weeks or in a 160 μg qd AM regimen for 12 weeks preceded by a twice-daily regimen (80 μg bid) for 4 weeks, or in an 80 μg bid regimen for 16 weeks, in adults and adolescents with mild to moderate persistent asthma not treated with steroids.
    E.2.2Secondary objectives of the trial
    To investigate the safety, compared to placebo, of ciclesonide at a daily dose of 160 μg administered either in a 160 μg qd AM regimen for 16 weeks or in a 160 μg qd AM regimen for 12 weeks preceded by an 80 μg bid regimen for 4 weeks, or in an 80 μg bid regimen for 16 weeks, in adults and adolescents with mild to moderate persistent asthma not treated with steroids.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Males or females ≥ 12 years of age;
    History of persistent bronchial asthma for at least 6 months prior to screening;
    Asthma therapy limited to bronchodilators only such as short-acting β2-agonists or methylxanthines for at least one month prior to screening;
    At screening and immediately prior to randomization, after an albuterol withhold of at least 6 hours, FEV1 ≥ 60% and ≤ 85% of predicted normal (see Appendix A of the protocol) and have a morning peak expiratory flow of (AM PEF) ≤ 95% of predicted normal (see Appendix B of the protocol);
    In subjects using methylxanthines: discontinuation of methylxanthines from at least 24 hours prior to the screening visit onwards;
    Evidence during the last 7 days (with non-missing measurements) of the screening period prior to randomization for all of the following signs for lack of asthma control:
    − Daytime asthma symptom score >1 (see Section 7.3.1.3 of the protocol) on 3 or more days,
    − Albuterol use on 3 or more days,
    − AM PEF <80% of predicted normal on 3 or more days;
    At screening or immediately prior to randomization, reversibility of FEV1 by at least 12% (relative to the pre-bronchodilator value in liters) after inhalation of 180 μg albuterol (ex-actuator);
    FEV1 at randomization within 15% of the FEV1 value (in liters) at screening;
    Non-smoker for at least 6 months prior to screening, with less than a 10 pack-year smoking history if previous smoker;
    Able to demonstrate acceptable oral inhaler technique with MDI (seeAppendix C of the protocol).
    E.4Principal exclusion criteria
    Any use of injectable or oral corticosteroids within 6 months prior to screening;
    Any use of an inhaled corticosteroid (ICS) within 30 days prior to screening;
    Use of β2-adrenergic blocking agents for any reason;
    Upper or lower respiratory tract infection within within 30 days prior to screening;
    History of chronic bronchitis, chronic obstructive pulmonary disease, or emphysema;
    History of life-threatening asthma, including a history of significant hypercarbia (pCO2 >45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
    More than 2 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
    Subjects on maintenance immunotherapy who either began their immunotherapy regimen or had a clinically relevant change in their immunotherapy regimen within 30 days prior to screening;
    Pregnancy. There are no specific studies of ciclesonide in pregnant women. Therefore pregnant women should be excluded from this study;
    • Breast feeding;
    • Female subjects of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) unless practicing an adequate method of birth control, or unless sexual abstinence is confirmed at informed consent, or unless premenarchal and prepared to accept counseling on reproductive issues in case of becoming menarchal;
    • Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol;
    • Treatment with any investigational product within 30 days prior to screening;
    • Previous randomization in this study;
    • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult;
    • Any clinically relevant deviation from normal in laboratory parameters that would limit participation in the study or interfere with interpretation of study results;
    • History of hypersensitivity to the study drug(s) or to drugs with a similar chemical structure;
    ntolerance to albuterol or to excipients in MDI (HFA-134a and ethanol);
    History of drug or alcohol abuse;
    Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study;
    Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy analysis will be an intention-to-treat (ITT) analysis of covariance (ANCOVA) of the change from baseline to the average of Week 12 (Visit 7) and Week 16 (Visit 8) FEV1 measurements, with factors for treatment, center, and gender, and with baseline FEV1 and age as covariates. In case of discontinuation before Week 16, the following last observation carried forward (LOCF) procedures will be used to determine the endpoint: for subjects who discontinue between Weeks 12 and 16, the average of the Week 12 and the end-of-study measurement will be used, and for subjects who discontinue before Week 12, the end-of-study measurement will be used. The FEV1 measured on Day 1 (Week 0, Visit 3) prior to randomization will be the baseline FEV1 value.
    The statistical comparison between the ciclesonide treatment regimens and placebo will be performed in a stepwise fashion to control Type 1 error, in the following order:
    1. Ciclesonide 80 μg bid will be compared against placebo at α = 0.05, two-sided. If this test is significant, it can be concluded that ciclesonide 80 μg bid is efficacious, and then proceed to Step 2.
    2. The average of the ciclesonide 160 μg qd AM and ciclesonide 80 μg bid —> 160 μg qd AM groups will be compared against placebo at α = 0.05, two-sided. If this test is significant, then proceed to Step 3. This step is included to ensure a closed testing procedure.
    3. Compare the ciclesonide 160 μg qd AM group vs. placebo and ciclesonide 80 μg bid —> 160 μg qd AM group vs. placebo, each at α = 0.05, two-sided.
    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
    Subjects will be treated with study medication for a total of 16 weeks (consisting of a 12-week maintenance treatment period preceded by a 4-week initial treatment period).
    recruitment is competitive. Enrollment into the screening or randomization phase of the study will be stopped when the anticipated or actual subject numbers have been achieved across all study sites.
    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 Yes
    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) Yes
    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 2006-04-18. 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 700
    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 Decision2006-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
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