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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   41189   clinical trials with a EudraCT protocol, of which   6743   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:2009-010267-17
    Sponsor's Protocol Code Number:CCD-0815-PR-0011
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-010267-17
    A.3Full title of the trial
    IN-VIVO DEPOSITION MEASUREMENT OF BECLOMETASONE AND FORMOTEROL AFTER INHALATION OF A SINGLE DOSE OF THE COMBINATION BDP PLUS FORMOTEROL NEXT (TM) DPI IN HEALTHY VOLUNTEERS, ASTHMATIC AND COPD PATIENTS
    A.4.1Sponsor's protocol code numberCCD-0815-PR-0011
    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 NEXT DPI
    D.3.2Product code CHF 1535 NEXT DPI
    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 INNBeclometasone Dipropionate
    D.3.9.1CAS number 5534098
    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 number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFormoterol Fumarate
    D.3.9.1CAS number 43229807
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This study is focused on asthma bronchiale and chronic obstructive pulmonary disease COPD).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary:
    To evaluate the amount of drug deposited within the lungs (intrapulmonary drug deposition relative to the nominal dose, DL, N) in healthy volunteers, asthmatic and COPD patients.
    E.2.2Secondary objectives of the trial
    Secondary:
    •To evaluate the intrapulmonary distribution and the extrathoracic deposition
    •To evaluate Formoterol, BDP and B17MP pharmacokinetics.
    •To evaluate the efficacy by lung function assessment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    Healthy volunteers:
    1.Males and females without childbearing potential aged 21-65 years;
    2.Ability to use the NEXT(TM)DPI;
    3.Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
    4.Non- or ex-smokers who smoked < 5 pack years (pack-years = the number of cigarette packs per day times the number of years e.g. < 20 cigarettes per day for 5 years and 40 cigarettes per day for 2.5 years) and stopped smoking > 1 year;
    5.Good physical and mental status, determined on the basis of the medical history and a general clinical examination;
    6.Normal blood pressure and heart rate (100 ≤ SBP ≤ 150; 45 ≤ DBP ≤90; 40 ≤ HR ≤ 100);
    7.Electrocardiogram (ECG) (12 lead) with computerized protocol interpretation considered as normal (120 ms ≤ PR ≤ 220 ms, QRS ≤ 120 ms, QTc ≤ 450 ms). Minor deviations are acceptable provided the at they are not judged clinically significant by the investigator.
    8.Results of laboratory tests within the normal ranges. Minor deviations are acceptable provided that they are not judged clinically significant by the investigator.
    9.Understanding of the study and agreement to give written informed consent before the first selection procedure

    Patients with Asthma:
    1.Males and females (without childbearing potential) asthma patients aged 21-65 years;
    2.Ability to use the NEXT(TM)DPI;
    3.Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
    4.Non- or ex-smokers who smoked < 5 pack years (e.g. < 20 cigarettes per day for 5 years and 40 cigarettes per day for 2.5 years) and stopped smoking > 1 year;
    5.Normal blood pressure and heart rate (100 ≤ SBP ≤ 150; 45 ≤ DBP ≤90; 40 ≤ HR ≤ 100);
    6.ECG (12 lead) with computerized protocol interpretation considered as normal (120 ms ≤ PR ≤ 220 ms, QRS ≤ 120 ms, QTc ≤ 450 ms). Minor deviations are acceptable provided that they are not judged clinically significant by the investigator.
    7.FEV1 ≥ 30% and < 80% of predicted for the patient’s normal value (according to the predicted value for spirometric function, European Coal and Steel Community values [2]) measured at least 8 hours after the last use of short-acting β2-agonist bronchodilators or short-acting anticholinergics, 72 hours after the last use of long-acting β2-agonist bronchodilators and 72 hours after the last use of long-acting anticholinergics;
    8.Reversibility of FEV1 ≥ 12% and at least 200 ml of the initial value 15 minutes after inhalation of 200 µg Salbutamol within the screening period;
    9.In good health on the basis of a medical history, physical examination, clinical laboratory studies and ECG with the exception of asthma;
    10.Understanding of the study and agreement to give written informed consent before the first selection procedure.


    Patients with COPD:
    1.Males and females without childbearing potential aged 40 – 70 years
    2.Ability to use the NEXT(TM)DPI;
    3.Body Mass Index (BMI) between 18.0 and 30.0 kg/m2;
    4.Normal blood pressure and heart rate (100 ≤ SBP ≤ 150; 45 ≤ DBP ≤90; 40 ≤ HR ≤ 100);
    5.ECG (12 lead) with computerized protocol interpretation considered as normal (120 ms ≤ PR ≤ 220 ms, QRS≤ 120 ms, QTc≤ 450 ms). Minor deviations are acceptable provided that they are not judged clinically significant by the investigator;
    6.Stable COPD within the past 4 weeks;
    7.Post bronchodilator FEV1 between 30% and 50% predicted values (30% ≤ FEV1 < 50%) documented at screening visit ;
    8.Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC)  0.70 (absolute value) documented at screening visit;
    9.Minimum smoking history of 10 pack-years (e.g. < 20 cigarettes per day for 10 years and 40 cigarettes per day for 5 years);
    10.Understanding of the study and agreement to give written informed consent before the first selection procedure.

    E.4Principal exclusion criteria
    Exclusion criteria
    All subjects:
    1.Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication;
    2.Positive HIV1 or HIV2 serology;
    3.Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
    4.Unsuitable veins for repeated venipuncture;
    5.Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception (according to CPMP/ICH 286/95 note 3 1). Postmenopausal women < 1 year must have efficient contraception;
    6.History of substance abuse or drug abuse within 12 months or with a positive urine drug screen;
    7.Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
    8.Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;
    9.Participation in another clinical trial less than 8 weeks prior to inhalation of the study medication; participation in study using radioactive material within 1 calendar year;
    10.Known sensitivity to Formoterol or Beclometasone or any of the excipients contained in any of the formulations used in the trial;
    11.Enzyme-inducing or inhibiting drugs taken within 2 months before the inhalation of the study medication.
    12.Concomitant severe diseases or diseases which are contra indications for the use of inhaled ß2-agonist or steroids;
    13.Use of any prescription drug for which concomitant beta-agonist or steroid administration are contraindicated;
    14.History of significant sensitivity, allergy or intolerance to study drug formulation ingredients;
    15.Recent relevant infectious disease (less than two months);
    16.Flu vaccination within 4 weeks prior to the screening visit;
    17.Other vaccination within 4 weeks prior to the screening visit;
    18.Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study but also the possible benefits or unwanted effects of the study treatments;


    Additional exclusion criteria for healthy volunteers
    1.Lung function measurements outside normal limits (Normal values: FEV1/FVC > 0.70 (absolute value) and FEV1 and FVC > 80% for the European Community for Coal and Steel 1993 predicted values) or other standard values for healthy volunteers;

    Additional exclusion criteria for patients with Asthma:
    1.Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months;
    2.Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days;
    3.Requirement of continuous supplemental oxygen therapy; the use of supplemental oxygen not exceeding 2 l/min, at night time only and/or only during exercise is allowed;
    4.Change in dose or type of any medications for asthma within 4 weeks prior to the screening visit;
    5.Asthma exacerbation within the 4 weeks prior to inclusion.

    Additional exclusion criteria for patients with COPD:
    1.Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months;
    2.Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days;
    3.Requirement of continuous supplemental oxygen therapy; the use of supplemental oxygen not exceeding 2 l/min, at night time only and/or only during exercise is allowed;
    4.Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit;
    5.COPD exacerbation within the 4 weeks prior to inclusion;
    6.History of asthma or any chronic respiratory diseases other than COPD.
    E.5 End points
    E.5.1Primary end point(s)
    Intrapulmonary lung deposition (DL, N) expressed as % of nominal 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 Yes
    E.6.5Efficacy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    lung deposition
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    lung deposition measurement
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    End of the trial: follow up phone call 7 days after visit 2a (described in protocol sections 6.12 and 7.1.4)
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 No
    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) No
    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 Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 2009-10-21. Yes
    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 state30
    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)
    described in the protocol 6.12; Modul II ,19.
    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 Decision2010-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-06
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