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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41229   clinical trials with a EudraCT protocol, of which   6756   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2007-002587-99
    Sponsor's Protocol Code Number:CCD-0605-PR-0021
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-26
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2007-002587-99
    A.3Full title of the trial
    A 24-week, multicenter, multinational, randomized, double-blind, triple-dummy, 3-arm parallel group study comparing the efficacy and safety of CHF 1535 200/6 (beclomethasone dipropionate 200 μg plus formoterol 6 μg/actuation), 2 puffs b.i.d., versus beclomethasone diproprionate HFA (250 μg/actuation), 4 puffs b.i.d., versus Seretide® 500/50 (fluticasone 500 μg plus salmeterol 50 μg/actuation), 1 inhalation b.i.d., in patients with severe asthma
    A.4.1Sponsor's protocol code numberCCD-0605-PR-0021
    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 SponsorCHIESI FARMACEUTICI S.p.A.
    B.1.3.4CountryItaly
    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 nameCHF 1535 HFA pMDI
    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 INNbeclometasone dipropionate
    D.3.9.1CAS number 5534-09-8
    D.3.9.3Other descriptive nameBDP
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.3.9.3Other descriptive nameFF
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 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 Yes
    D.2.1.1.1Trade name Clenil
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameClenil 250 μg
    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 INNbeclometasone dipropionate
    D.3.9.1CAS number 5534-09-8
    D.3.9.3Other descriptive nameBDP
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 No
    D.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Seretide Accuhaler 500/50
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK Ltd.
    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 nameSeretide Accuhaler 500/50
    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 80474-14-02
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsalmeterol xinafoate
    D.3.9.1CAS number 89365-50-4
    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 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 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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Patient with severe 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
    In symptomatic patients on high-doses ICS (Inhaled Corticosteroid) beclomethasone diproprionate (two puffs b.i.d.), to demonstrate the superiority of CHF 1535 200/6 (two puffs b.i.d.) versus a high dose of BDP (beclomethasone diproprionate 2000 μg/day) given as monotherapy, in terms of pulmonary function (change from baseline in pre-dose morning FEV1 measured at clinic) and asthma control (change from baseline in percentage of complete days without asthma symptoms), and the non-inferiority versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline in pre-dose morning FEV1 measured at clinic) during a 24-week treatment period.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of the treatments on additional lung function parameters and clinical outcome measures, to assess the achievement of asthma control (according to the criteria established in GINA revised 2006), to assess the safety and the tolerability of CHF 1535 200/6 and to perform a pharmaco-economic evaluation in the perspective of the HealthCare System.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There are 2 sub-studies included in the protocol (not all sites will participate to those substudies):
    - a subgroup of subjects (30% of all patients) will be selected for 12-h overnight urinary cortisol and adrenocorticotropic hormone (ACTH) test.
    12-h overnight urine (which will be collected for free cortisol and creatinine excretion) and plasma response to ACTH injection will be used as diagnostic tests to assess the potential effect of inhaled corticosteroids to cause suppression of the hypothalamic-pituitary-adrenal axis.
    - a subgroup of subjects (10% of all patients) will be selected for a 24-h Holter monitoring.
    24-hour Holter monitoring will be performed to assess whether electrophysiologic effects (heart rate and rythm) could be observed in patients receiving inhaled medications.
    E.3Principal inclusion criteria
    Patient will be enrolled at Visit 1 into the run-in period if they meet each and every one of the following criteria:
    1. Subject’s written informed consent and written informed consent by parents/legal
    representatives (adolescent patients).
    2. Outpatients of both sexes aged ≥ 12 and ≤ 70 years.
    3. Evidence of asthma demonstrated by a documented positive response to the reversibility test, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI. In case this is not achieved, a historically documented FEV1 reversibility within the previous 12 months is acceptable.
    4. Patients with severe persistent asthma diagnosed according to GINA guidelines (revised 2006).
    5. Levels of asthma control, during each of the two previous weeks (to be checked at screening and at randomisation visits), defined as:
    → 1 or more of the following:
    - Daytime symptoms → more than twice/ week;
    - Limitations of activities → any;
    - Nocturnal symptoms/awakening → any;
    - Need for reliever/rescue treatment → more than twice/ week.
    6. Patients on previous treatment with high doses of ICS (> 1000 μg BDP CFC daily or equivalent) or ICS + LABA fixed or free combinations (daily dose of budesonide 800 μg/fluticasone 500 μg or equivalent ICS doses plus formoterol 24 μg or salmeterol 100μg) at a stable dose for at least 2 months prior to inclusion.
    7. Patients who meet the following requirement: FEV1 ≥ 40% and < 80% of predicted normal values and at least 0.9 L, after appropriate washout from bronchodilators.
    8. A cooperative attitude and ability to be trained in the proper use of a pMDI, an
    Accuhaler® and a portable electronic peak flow meter (SpirotelTM).
    E.4Principal exclusion criteria
    Patient will not be enrolled at Visit 1 into the run-in period and will not be randomized to treatments at Visit 2 (i.e. these criteria will be also reviewed at Visit 2) if they meet one or more of the following criteria:
    1. Pregnant or lactating women. Females of childbearing potential without an efficient contraception (e.g. oestro-progestatives, condoms).
    2. Having received an investigational drug within 2 months.
    3. Inability to comply with study procedures or with study treatment intake.
    4. Seasonal asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
    5. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease.
    6. Patients who suffer from COPD as diagnosed by the GOLD guidelines (2006).
    7. Previous or current smokers who have a smoking history greater than 5 pack years, (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
    8. Diagnosis of restrictive lung disease (e.g. kyphoscoliosis, ankylosing spondylitis).
    9. Patients who have an uncontrolled cardiovascular (e.g., uncontrolled hypertension), respiratory, hematologic, immunologic, renal, neurologic, hepatic, endocrine (e.g., uncontrolled diabetes mellitus) or other disease, or any condition that might, in the judgment of the Investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study.
    10. Patients who have a history of coronary artery disease, cerebrovascular disease, and cardiac arrhythmias.
    11. Patients who have a concomitant disease of poor prognosis (e.g., cancer).
    12. Clinically relevant laboratory abnormalities such as (but not limited to hypokaliemia, that might compromise patient's safety or compliance, interfere with evaluation, or preclude completion of the study, in the judgment of the Investigator. Patients with uncontrolled diabetes including patients with a history of blood glucose levels consistently out of the normal range or HbA1C > 8.0% measured at Visit 1.
    13. Patients who have an abnormal QTc interval value in the Screening visit ECG test (i.e., > 450 msec in males or > 470 msec in females).
    14. Patients having received a live-attenuated virus vaccination within two weeks prior to screening or during the run-in.
    15. Patients mentally or legally incapacitated.
    16. Patients who abuse alcohol.
    17. Intolerance/hypersensitivity or contra-indication to treatment with β2-agonists and/or inhaled corticosteroids.
    18. Major surgery in the previous 3 months.
    19. Any change in dose, schedule, formulation or product of previous ICS or fixed/free combination ICS + LABAs in the 2 months prior to screening visit.
    20. Any change in dose, schedule, formulation or product of other concomitant asthma treatments in the 2 months prior to screening visit.
    21. Moderate/severe exacerbations and/or intake of oral corticosteroids during the 2-week run-in period.
    22. Patients treated with slow-release corticosteroids in the 3 months prior to screening visit.
    23. Patients treated with non-potassium sparing diuretics, beta-blocking drugs, quinidine, quinidine-like anti arrhythmics, or any medication with a QTc prolongation potential or a history of QTc prolongation.
    24. Patients treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, unless already taken at stable doses at the screening visit.
    25. Patients who are receiving therapy that could interact with steroids, such as enzyme inhibitors (macrolide antibiotics, antifungal oral therapy) or induced (anticonvulsants, rifampin).
    26. Patients being treated with anti-IgE antibodies.
    27. Patients who have had a respiratory tract infection within 2-months prior to Visit 1.
    E.5 End points
    E.5.1Primary end point(s)
    Two co-primary variables are defined:
    - Change from baseline to end of treatment in pre-dose morning FEV1 (L) (measured
    at clinic visit).
    - Change from baseline to end of treatment in percentage of complete days without
    asthma symptoms (asthma symptom scores recorded daily at home on electronic
    peak flow meter).
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA95
    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 No
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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 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 state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 929
    F.4.2.2In the whole clinical trial 1050
    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 Decision2008-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-13
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