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    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-002238-35
    Sponsor's Protocol Code Number:CLI-05993CB1-01
    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:2019-10-31
    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 number2019-002238-35
    A.3Full title of the trial
    A SINGLE-DOSE, UNCONTROLLED, OPEN LABEL, NON-RANDOMIZED,
    CLINICAL PHARMACOLOGY STUDY OF CHF 5993 100/6/12.5 μg PMDI (FIXED COMBINATION
    OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) IN ASTHMATIC ADOLESCENT PATIENTS AND ADULT PATIENTS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open label, non-randomized, single dose PK/PD study in adolescent asthmatic patients and adult asthmatic patients
    A.4.1Sponsor's protocol code numberCLI-05993CB1-01
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/179/2019
    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 Farmaeutici 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 pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address Via Palermo 26/A
    B.5.3.2Town/ city Parma
    B.5.3.3Post code 43122
    B.5.3.4CountryItaly
    B.5.4Telephone number+390521279093
    B.5.6E-mailclinicaltrials_info@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 Trimbow
    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 nameCHF 5993 pMDI
    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 5534-09-8
    D.3.9.2Current sponsor codeCHF718
    D.3.9.3Other descriptive nameBDP
    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.3.8INN - Proposed INNFORMOTEROL FUMARATE
    D.3.9.1CAS number 43229-80-7
    D.3.9.2Current sponsor codeCHF1531.02
    D.3.9.3Other descriptive nameFF
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.2Current sponsor codeCHF5259.02
    D.3.9.3Other descriptive nameGB
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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) 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 20.0
    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 the systemic exposure to B17MP (active metabolite of BDP), formoterol and Glycopyrronium Bromide (GB) as AUC0-t, (index of total systemic exposure) after inhalation of CHF 5993 pMDI in adolescent asthmatic patients in comparison to adult
    asthmatic patients.
    E.2.2Secondary objectives of the trial
     To evaluate the pharmacokinetic profile of BDP and additional PK parameters of B17MP, formoterol and GB after inhalation of CHF 5993 pMDI in adolescent asthmatic patients in comparison to adult asthmatic patients.
     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, formoterol and GB after inhalation of CHF 5993 pMDI in adolescent asthmatics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient’s and / or patient legal representative’s/parents’ (where applicable) written informed consent obtained prior to any study related procedure.
    2. Ability to understand the study procedures, the risks involved, and ability to be trained to use the pMDI device correctly with AIM™ (Aerosol Inhalation Monitor) Vitalograph®.
    3. Male and female adolescents, aged ≥ 12 and < 18 years or male and female adults, aged ≥ 18 and < 65 years.
    4. Body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 inclusive.
    5. A diagnosis of asthma as defined in the GINA guidelines (updated 2019) 6 months before the screening visit.
    6. Male/female adolescent and adult patients with controlled asthma according to GINA guidelines (updated 2019) to allow a wash out period from inhaled BDP of 2 days before study treatment visit.
    7. Male/female adolescents and adults with controlled asthma on regular treatment with medium doses of ICS according to GINA guideline alone or in fixed dose combinations with LABA and using short-acting inhaled β2-agonists as a reliever. Inhaled Corticosteroid Adults and adolescents
    8. 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 6h prior to screening or 24 hours in case of long acting β2-agonist.
    9. Non-smokers or ex-smokers who smoked < 5 pack years (packyears= the number of cigarette packs per day, times the number of years) and stopped smoking > 1 year prior to screening.
    10. Good physical and mental status, determined on the basis of the medical history and a general clinical examination, at screening and at Visit 1 before dosing.
    11. Female patients of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile) and female patients of childbearing potential (WOCBP) fulfilling one of the following
    criteria:
    a. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up visit or
    b. WOCBP with non-fertile male partners (contraception is not required in this case).
    E.4Principal exclusion criteria
    1. Blood donation (equal or more than 450 ml) or blood loss, less than 2 months prior to screening or prior to Visit 1.
    2. Abnormal haemoglobin level defined as < 12,0 g/dl in females and < 14,0 g/dl in males.
    3. For females only: pregnant and lactating female patients, confirmed by a positive serum pregnancy test at screening or urine pregnancy test at Visit 1 before dosing.
    4. Diagnosis of COPD, in adult patients, as defined by the current GOLD guidelines (2019 Report).
    5. Positive to HIV1 or HIV2 or positive results for Hepatitis which
    indicates acute or chronic Hepatitis B (i.e. positive HB surface antigen HBsAg, positive HB core antibody anti-HBc) or Hepatitis C (positive HCV antibody).
    6. Unsuitable veins for repeated venepuncture.
    7. Documented history of alcohol abuse within 12 months prior to screening.
    8. Documented history of drug abuse within 12 months prior to screening, or positive urine drug test performed at screening or before dosing.
    9. Patients who have a positive urine test for cotinine at screening or before dosing.
    10. Clinically relevant abnormal laboratory values, suggesting an unknown disease and requiring further clinical investigation.
    11. Clinically relevant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.
    12. Known intolerance/hypersensitivity to any of the excipients/components contained in any of the formulations used in the trial.
    13. Patients with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of an anticholinergic.
    14. Abnormal 12-lead digitized Electrocardiogram (12-lead ECG) parameter (i.e.: QRS > 120 msec and/or PR > 210 msec and/or HR < 40 bpm and/or HR > 110 bpm and/or QTcF > 450 ms for males or QTcF > 470 ms for females, considering the average from triplicate) or 12-lead ECG evaluated as abnormal clinically significant by the investigator, at screening.
    15. Abnormal Blood Pressure (i.e.: Diastolic Blood Pressure > 90 mmHg and/or Systolic Blood Pressure > 140 mmHg, considering the average from triplicate) at screening.
    16. Participation in another clinical trial with an investigational drug in the 30 days or 5 half-lives of that investigational drug (whichever is longer) preceding the administration of the study drug; a longer and more appropriate time could be considered by the principal investigator based on the elimination half-life and/or
    long-term toxicity of the previous investigational drug.
    17. Patients taking enzyme-inducing drugs, enzyme-inhibiting drugs, biologic drugs or any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) in the 3 months before screening or Visit 1.
    18. Patients who have a high caffeine intake (> 5 caffeinated beverages e.g., coffee, tea, cola per day).
    19. Patients who have had a lower respiratory tract infection (LRTI) within 4 weeks prior to screening or Visit 1.
    20. Patients who are night shift workers with night shifts within 8 weeks prior to screening or Visit 1 and during the study.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy and safety endpoints are standard for evaluation of this drug class in Asthma and will allow to determine the effect of the IMP. Please refer to the protocol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Determination of Glycopyrronium Bromide levels in human plasma &
    Determination of potassium and glucose in human serum:

    Blood collection will occur prior to dosing and in the 0-10h interval after
    dosing, at following time points: pre-dose (within 75 min from dosing), 5, 15 and 30 min, 1, 2, 4, 8 and 10 hours post-dose.
    E.5.2Secondary end point(s)
    The efficacy and safety endpoints are standard for evaluation of this drug class in Asthma and will allow to determine the effect of the IMP. Please refer to the protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The efficacy and safety endpoints are standard for evaluation of this drug class in Asthma and will allow to determine the effect of the IMP. Please refer to the protocol.
    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 No
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    A single-dose, uncontrolled, open label, non-randomized
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    LPLV
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial 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: 40
    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: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    None
    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 Decision2020-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-04
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