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    Summary
    EudraCT Number:2005-001242-17
    Sponsor's Protocol Code Number:BY9010/M1-207
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-09-08
    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 number2005-001242-17
    A.3Full title of the trial
    Efficacy and Safety – Study by ALTANA on Ciclesonide in Pre-school Asthma Patients

    Estudio de eficacia y seguridad realizado por ALTANA con Ciclesonide en pacientes pre-escolares con asma
    A.3.2Name or abbreviated title of the trial where available
    Balloon
    A.4.1Sponsor's protocol code numberBY9010/M1-207
    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.2.1.1.1Trade name Alvesco 40
    D.2.1.1.2Name of the Marketing Authorisation holderALTANA Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAlvesco 40
    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.3.9.2Current sponsor codeBY9010
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration 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 No
    D.IMP: 2
    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 80
    D.2.1.1.2Name of the Marketing Authorisation holderALTANA Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAlvesco 80
    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.3.9.2Current sponsor codeBY9010
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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: 3
    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 160
    D.2.1.1.2Name of the Marketing Authorisation holderALTANA Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAlvesco 160
    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.3.9.2Current 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.3.11 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 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 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
    To assess the efficacy of ciclesonide (CIC) 40 µg, 80 mg, and 160 mg (ex mouthpiece) in asthmatic children 2 to 6 y old.
    E.2.2Secondary objectives of the trial
    To study the safety and tolerability of ciclesonide.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    · Written informed consent by the patient’s parents or legal guardians,
    · Male or female outpatients,
    · Age 2 to 6 y,
    · Good health with the exception of asthma,
    · Documented diagnosis of asthma for > or = 6 months with persistent or repeated wheezing, and one or more major risk factors, e.g.:
    - history of allergies,
    - history of eczema,
    - family history of asthma,
    and/or two or more minor risk factors, e.g.:
    - eosinophilia,
    - dyspnoea without having a cold,
    - allergic rhinitis.

    Only in case risk factors cannot be determined, a positive Phadiatop result (determined at B0) will be accepted.
    · Stable clinical state (e.g. no asthma exacerbation or respiratory tract infection within the last 30 d prior to B0),
    · Either,
    - use of rescue medication (prn) only, or
    - pre-treatment with < or = 250 µg fluticasone propionate/d (or equivalent), or
    - pre-treatment with < or = 125 µg fluticasone propionate/d (or equivalent) in combination with a LABA and/or with another non-steroidal controller medication, or
    - pre-treatment with other non-steroidal controller medication, at a constant dosage for at least 30 d prior to B0
    E.4Principal exclusion criteria
    Diseases and health status:
    · Concomitant severe diseases,
    · Diseases contraindicated for the use of inhaled steroids (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial, or viral infections of the lower respiratory tract demanding specific treatment, nematode infestation),
    · Other relevant lung diseases causing impairment in pulmonary function,
    · Hospitalization due to respiratory syncytial virus (RSV) bronchiolitis within the last 12 months prior to B0,
    · Three or more hospitalizations for wheezing, coughing, or shortness of breath within the last 12 months prior to B0,
    · Recurrent, episodic wheezing only,
    · History of life-threatening asthma (i.e. intubation for asthma and/or respiratory arrest, anoxic seizures, significant hypercapnia in the setting of an asthma exacerbation),
    · History of any mechanical ventilation,
    · Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation,· Premature birth (i.e. <32 weeks gestation),· Height outside normal height percentile (= 5-95%)

    Medication:
    · Known or suspected hypersensitivity to inhaled steroids or to other excipients of the MDI,
    · Known or suspected hypersensitivity to salbutamol or montelukast,
    · Regular use of rescue medication for prophylactic reasons,
    · Use of systemic steroids within the last 30 d (injectable depot steroids: 6 weeks) prior to B0, or on more than 60 d within the last 2 y,
    · Use of prohibited medication or washout times of prohibited medication cannot be adhered to,
    · Beginning or change of immunotherapy within the study period
    · Systemic treatment for non-respiratory chronic or recurrent diseases,

    Other criteria:
    · Participation in another study within the last 30 d prior to B0,
    · Previous enrollment into the current study,
    · Known or suspected non-compliance of parents/legal guardians and/or patients (e.g. inability to follow study procedures, language problems),Intention of the parents/legal guardians and patients to relocate during the study, preventing adherence to the visit schedule
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy variable of primary interest:
    · Time to first lack of improvement or severe asthma exacerbation

    Efficacy variable of secondary interest:
    · Rate of patients with lack of improvement or severe asthma exacerbation
    · Rate of patients with lack of improvement
    · Rate of patients with severe asthma exacerbation
    · Time to first lack of improvement
    · Time to first severe asthma exacerbation
    · Asthma symptom score from diary (total, daytime, and nighttime)
    · Use of rescue medication
    · Patient perceived asthma control
    · Quality of life data (PACQLQ)
    · Morning and evening PEF from diary*
    · PEF fluctuation*·
    · Pulmonary function variables (FEV1, PEF, FEF25-75%) measured at the investigational sites*

    *(in 4 to 6 y old patients, able to perform reliable pulmonary function measurements)

    Safety variables of interest:
    · Adverse events
    · Physical examination
    · Vital signs
    · Laboratory work-up
    · Serum cortisol
    · Urine cortisol variables (first morning urine)
    · Body growth determined by stadiometry (selected sites)
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 months13
    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 months13
    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) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    · Male or female outpatients aged 2 to 6 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 525
    F.4.2.2In the whole clinical trial 1025
    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 Decision2005-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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