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    Summary
    EudraCT Number:2004-002983-80
    Sponsor's Protocol Code Number:BY9010/M1-502
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-26
    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 ConcernedAustria - BASG
    A.2EudraCT number2004-002983-80
    A.3Full title of the trial
    Comparison of the Efficacy of a Fixed Combination of Ciclesonide and Formoterol versus a Fixed Combination of Fluticasone and Salmeterol
    A.3.2Name or abbreviated title of the trial where available
    EXCITED
    A.4.1Sponsor's protocol code numberBY9010/M1-502
    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 nameCiclesonide - Formoterol Fumarate Dry Powder Inhaler
    D.3.2Product code BY9010
    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.3.8INN - Proposed INNCiclesonide
    D.3.9.1CAS number 126544-47-6
    D.3.9.2Current sponsor codeBY9010
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFormoterol-Fumarate
    D.3.9.1CAS number 43229-80-7
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4,5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Atmadisc Diskus
    D.2.1.1.2Name of the Marketing Authorisation holderSchwarz Pharma AG, Monheim
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAtmadisc Diskus
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    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 INNFluticasone Propionate
    D.3.9.1CAS number 80474-14-2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSalmeterol Xinafoate
    D.3.9.1CAS number 94749-08-3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder, pre-dispensed
    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 bronchiale
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 5.1
    E.1.2Level llt
    E.1.2Classification code 10003553
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Pilot study to assess the efficacy of a fixed combination of ciclesonide and formoterol in comparison to a fixed combination of fluticasone and salmeterol, both administered twice daily (bid) by dry powder inhalers (DPI), in patients with persistent asthma bronchiale.
    E.2.2Secondary objectives of the trial
    Additionally, the study will provide further data on the safety and tolerability of a fixed combination of ciclesonide and formoterol.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Written informed consent
    - Male or female outpatients
    - Age 12 to 75 years
    - History of bronchial asthma for at least 6 months
    - Patients, who are in good health with the exception of asthma, and who have
    - FEV1 > 60% to < 80% of predicted, when rescue medication has been withheld for at least 6 h before pulmonary function measurement. This applies to all eligible patients, either pre-treated with a constant dose of < or = 500 µg fluticasone (or equivalent) per day only, or pre-treated with a constant dose of < or = 250 µg fluticasone (or equivalent) per day in combination with:
    -- an inhaled long-acting ß-agonists (LABA) in a fixed or free combination, or
    -- sustained-release theophylline, or
    -- a leukotriene antagonist, or
    -- a lipoxygenase inhibitor, or
    -- an inhaled anticholinergic, or
    -- an oral ß-agonist, or
    -- inhaled disodium cromoglycate, or
    -- inhaled nedocromil
    during at least four weeks prior to entry in the study.
    E.4Principal exclusion criteria
    Diseases and health status:
    - Clinically relevant abnormal laboratory values (e.g. abnormal serum potassium and glucose levels) suggesting an unknown disease and requiring further clinical evaluation,
    - Concomitant severe diseases or diseases which are contraindications for the use of inhaled corticosteroids (ICS) (e.g. active and inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment), or contra-indications for the use of long-acting beta2-agonists (LABAs, e.g. di-agnosis or history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, uncontrolled hypertension, hyperthyroid-ism, thyrotoxicosis, phaeochromocytoma, hypokalaemia, prolonged QTc interval (male > 430ms, female > 450ms) or tachyarrhythmia,
    - Suffering from chronic obstructive pulmonary disease (COPD) (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function (e.g. infection of lower airways within 4 weeks prior to entry into the study),
    - Current smoking or cessation of smoking within the last 6 months,
    - Previous smoking with a smoking history > or = 10 cigarette pack-years,
    - More than one in-patient hospitalization or emergency care visit due to asthma exacerbations in the past year before B0

    Medications:
    - Use of injectable glucocorticosteroids or oral systemic glucocorticos-teroids within 2 months prior to entry into the study, or more than 3 courses during the last 6 months,·
    - Use of other drugs not allowed and washout times of prohibited drugs cannot be adhered to,
    - Known or suspected hypersensitivity to ICS, salmeterol, formoterol, lactose monohydrate or to other excipients of the DPI,
    - Known or suspected hypersensitivity to salbutamol or to excipients of the MDI,
    - Beginning of immunotherapy within the study period,
    - Pre-treatment with variable doses of ICS, either alone or in combina-tion with a non-steroidal controller, during the last 4 weeks prior to en-try into baseline period

    Common criteria:
    - Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of child-bearing potential,
    - Participation in another study within the 30 days preceding and during the present study,
    - Previous enrolment into the current study,
    - Enrolment of the investigator, his/her family members or employees at the investigational site,
    - Known or suspected non-compliance, alcohol or drug abuse,
    - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders,
    - Reversal of sleep pattern (e.g. night shift workers).
    E.5 End points
    E.5.1Primary end point(s)
    Primary variable:·
    - FEV1 (last value compared to T0).

    Co-Primary variable:
    - Proportion of days on which a patient perceived asthma control (based on asthma symptom-free and rescue medication-free days).

    Secondary variables:
    - Morning and evening PEF from electronic diary (last week and weekly comparisons to W0),
    - FEV1 (T6 and T3 compared to T0),
    - FVC (last value, T6 and T3 compared to T0),
    - FEF25-75% (last value, T6 and T3 compared to T0)
    - Asthma symptom score (24 h, daytime as well as nighttime score) (last week and weekly comparisons to W0),
    - Use of rescue medication (last week and weekly comparisons to W0),
    - Proportion of days without nocturnal awakenings,
    - Proportion of days without use of rescue medication,
    - Proportion of days without asthma symptoms,
    - Onset of action as assessed by morning and evening PEF, asthma symptoms and use of rescue medication,
    - Time to the first asthma exacerbation,
    - Proportion of patients with an asthma exacerbation.

    Safety variables:
    - Physical examination,
    - Vital signs (ECG, BP, HR),
    - 24 h urine cortisol levels,
    - AEs,
    - Laboratory examinations,
    - Number of patients with oral candidiasis confirmed by culture.
    - Number and diameter assessment of skin bruises
    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 Yes
    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) 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) Yes
    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 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 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 years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    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 2004-11-26. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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 Decision2004-12-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-08-02
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