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    Summary
    EudraCT Number:2011-005108-14
    Sponsor's Protocol Code Number:CCD-1104-PR-0062
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-005108-14
    A.3Full title of the trial
    A single- dose, open label, randomized, 3-way crossover, clinical pharmacology study of CHF 1535 100/6 pMDI (fixed combination of beclomethazone dipropionate 100 μg plus formoterol fumarate 6 μg) with or without spacer device versus the free combination of licensed beclomethasone pMDI and formoterol pMDI in asthmatic adolescent patients and one open arm for adult patients as control group treated with CHF 1535 100/6 pMDI.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to test that the drug CHF 1535 100/6 (fixed combination of an anti-inflammatory drug and relaxing airways drug) delivered via pressurized inhaler using or not a spacer device is as effective in adolescent population as the licensed free combination of the same substances and compare it with administration in adults.
    A.4.1Sponsor's protocol code numberCCD-1104-PR-0062
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/192/2011
    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 supportChiesi Farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiesi Farmaceutici S.p.A.
    B.5.2Functional name of contact pointChiesi Farmaceutici S.p.A.
    B.5.3 Address:
    B.5.3.1Street AddressVia Palermo 26/A
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43122
    B.5.3.4CountryItaly
    B.5.4Telephone number+390521 2791
    B.5.6E-mailg.lucci@chiesi.com
    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 Yes
    D.2.1.1.1Trade name Foster®
    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.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation No
    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 5534-09-08
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.9.4EV Substance CodeSUB02257MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Atimos®
    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.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.9.4EV Substance CodeSUB02257MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Qvar®
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK Limited
    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.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation No
    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 5534/09/08
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate, in adolescents, the systemic exposure to B17MP (active metabolite of BDP) as
    AUC0-t, after inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber
    Plus™) in comparison with the already licensed free combination of BDP pMDI and formoterol
    pMDI without spacer.
    E.2.2Secondary objectives of the trial
    - To evaluate the pharmacokinetic profile of BDP and formoterol and additional PK
    properties of B17MP after inhalation of CHF 1535 100/6 pMDI both with and without
    spacer in comparison with a free combination of licensed BDP and Formoterol pMDIs.
    - To evaluate the systemic effects in terms of heart rate and circulating potassium and glucose
    levels and also the general safety and tolerability profile of BDP/B17MP and formoterol of
    CHF 1535 100/6 pMDI fixed combination both with and without spacer.
    - To evaluate, in adolescents, the effects of the spacer device (AeroChamber Plus™) on the
    systemic exposure to BDP/B17MP and formoterol after inhalation of the fixed combination.
    - To evaluate the systemic exposure to BDP/B17MP and formoterol after inhalation of CHF
    1535 pMDI in adolescents in comparison to adults without the spacer device.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female adolescents, aged ≥ 12 and < 18 years or male and female adults, aged ≥ 18
    and ≤ 65 years.
    2. Written informed consent obtained by the patient in case of adult patients and by parents/legal
    representative and by the minor (according to local regulation).
    3. A diagnosis of asthma as defined in the GINA guidelines (updated 2010) 6 months before the
    screening visit.
    4. Male/female adolescent and adult patients with asthma stable enough, according to GINA
    guidelines (updated 2010) and based on the Investigator’s opinion, to allow a wash out period
    from inhaled BDP of 2 days before study each single day study treatments and any ICS other
    than BDP of 1 day before each single day study treatments.
    5. Male/female adolescents and adults asthmatic patients already treated with ICS or ICS/longacting
    inhaled β2-agonists or using short-acting inhaled β2-agonists as reliever to control
    asthma symptoms.
    6. Adolescents and adults with a forced expiratory volume in one second (FEV1) > 70% of
    predicted values (% pred) after withholding short acting β2-agonist treatment for a minimum of
    6 h prior to screening or 24 hours in case of long acting β2-agonist.
    7. Non- or ex-smokers who smoked less than 5 pack-years (e.g. < 20 cigarettes per day for 5 years)
    and stopped smoking for at least 1 year.
    8. A cooperative attitude and ability to be trained about the proper use of pMDI with and without
    a spacer device and compliant to study procedures.
    9. Body mass index (BMI) ≥18.5 and ≤ 32 kg/m2
    E.4Principal exclusion criteria
    1. Pregnant or breast-feeding female patients. Sexually active female not using efficient
    contraception throughout the entire study period (e.g. oestro-progestatives, condoms,
    intrauterine devices). A urinary pregnancy test will be performed at screening and treatment
    visits (mandatory in the adult population and at discretion of the investigator in the adolescent
    population) in women of childbearing potential;
    2. Having received an investigational drug within 2 months before the screening visit (Visit 1)
    3. Diagnosis of COPD, in the adult patients, as defined by the current GOLD guidelines (updated
    2010).
    4. Known hypersensitivity to the active treatments.
    5. Inability to perform the required breathing technique and blood sampling.
    6. Hospitalization due to exacerbation of asthma within 1 month prior to screening visit.
    7. Lower respiratory tract infection within 1 month prior to screening visit;
    8. Obesity, i.e. > 97% weight percentile by local standards.
    9. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic,
    endocrine diseases, that may interfere with patient’s safety, compliance, or study evaluations,
    according to the Investigator’s opinion;
    10. History of drug addiction or excessive use of alcohol (weekly intake in excess of 28 units
    alcohol; one unit being a glass of beer, wine or a measure of spirits), or excessive consumption
    of xanthine containing substances (daily intake in excess of 5 cups of coffee, tea, cola, etc) or
    psychological or other emotional problems likely to invalidate informed consent, or limit the
    ability of the subject to comply with the protocol requirements;
    11. Treatment with a xanthine derivative (e.g. theophylline) formulations in the 4 weeks prior to
    screening visit;
    12. Blood donation (450 mL or more) (for the adult population) or significant blood loss in the 12
    weeks before the screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    Plasma AUC0-t for B17MP
    E.5.1.1Timepoint(s) of evaluation of this end point
    The area under the plasma concentration vs. time curve observed from time 0 up to the last
    measurable concentration will be computed using the linear trapezoidal rule [13]. An 8 hour value is required for derivation of AUC0-t.
    Nine (9) blood samples of approximately 1 mL for the determination of BDP and its metabolite B17MP in plasma will be collected in the 0-8 h interval after dosing [pre-dose (within 5 minutes from dosing), 5 min, 15 min, 30 min, 1, 2, 4, 6, 8 hours post dose].
    E.5.2Secondary end point(s)
    Pharmacokinetics:
    - Plasma BDP and formoterol AUC0-t, AUC0-inf , Cmax, tmax and t½
    - Plasma B17MP AUC0-0.5h, AUC0-inf, Cmax, tmax and t½
    Pharmacodynamics:
    - Plasma Potassium Cmin, tmin and AUC0-t
    - Plasma Glucose Cmax, tmax, AUC0-2h and AUC0-t
    Efficacy:
    - Peak FEV1, FEV1 time averaged value (FEV1 AUC0-8h/8h)
    Safety:
    - Heart Rate: Time averaged value (calculated as AUC0-8h/8h).
    - General tolerability of the treatments, adverse events and adverse drug reactions.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK - BDP/B17Mp/Formoterol in plasma at pre-dose, 5 min, 15 min, 30 min, 1, 2, 4, 6, 8 hours post dose
    PD - Potassium and Glucose at pre-dose, 30 min, 1, 2, 4, 6, 8 hours post dose;
    Safety - Heart rate will be measured at pre-dose, 5 min, 10 min, 15 min, 30 min, 1, 2, 4, 6, 8 hours post dose
    Efficacy - Lung function measurements (FEV1) at pre-dose, 30 min, 1, 2, 4, 6, 8 hours post dose
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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.8.2.4Number of treatment arms in the trial4
    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 No
    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
    last patient Follow-Up.
    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 months9
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 30
    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.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    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 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 state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At study completion, it is under the Investigator’s responsibility to prescribe the most appropriate
    treatment for the patient or restore the initial therapy.
    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 Decision2012-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-24
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