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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2006-005557-30
    Sponsor's Protocol Code Number:FB/PS/14/165/06
    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:2006-12-12
    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 number2006-005557-30
    A.3Full title of the trial
    In-vivo deposition measurement of formoterol and beclomethasone after inhalation of a single dose of the combination Formoterol plus BDP HFA pMDI (Foster®, Chiesi) in healthy volunteers, asthmatic and COPD patients
    A.4.1Sponsor's protocol code numberFB/PS/14/165/06
    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 Yes
    D.2.1.1.1Trade name Foster
    D.2.1.1.2Name of the Marketing Authorisation holderAsche Chiesi GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameFoster
    D.3.2Product code CHF 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 INNFormoterol Fumarate
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBeclomethasone Dipropionate
    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.3.11 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The 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 8.1
    E.1.2Level PT
    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
    The aim of the study is to assess intrapulmonary deposition of Foster.
    E.2.2Secondary objectives of the trial
    Secondary objective is to describe intrapulmonary distribution, pharmacokinetic properties of the drug formulation and evaluation of the lung function.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy subjects:
    1. Age 21 - 70
    2. Ability to properly use the pMDI
    3. Body Mass Index (BMI) between 18.0 and 30 kg/m2
    4. Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine
    DBP 50-90 mmHg, heart rate 50-90 bpm)
    5. Electrocardiogram (12 lead) with computerized protocol interpretation
    considered as normal (120 ms≤PR≤220ms, QRS≤120ms, QTc≤450ms).
    6. Non-smokers or ex-smokers with a smoking history of less than 5 pack-
    years and stopped smoking at least one year ago.
    7. written informed consent

    Patients with Asthma:
    1. Age 21 - 70
    2. Ability to properly use the pMDI
    3. Body Mass Index (BMI) between 18.0 and 30 kg/m2
    4. Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine
    DBP 50-90 mmHg, heart rate 50-90 bpm).
    5. Electrocardiogram (12 lead) with computerized protocol interpretation
    considered as normal (120 ms≤PR≤220ms, QRS≤120ms, QTc≤450ms).
    6. Patients with moderate persistent or severe persistent Asthma according
    to the GINA Classification of Asthma Severity by Daily Medication Regimen
    and Response to Treatment.
    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) 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 30
    minutes after inhalation of 200 mcg 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. Non-smokers or ex-smokers with a smoking history of less than 5 pack-
    years (e.g. < 20 cigarettes per day for 5 years or 40 cigarettes per day for
    2.5 years) and stopped smoking at least 1 year ago.
    11. written informed consent

    Patients with COPD:
    1. Age 40 - 70
    2. Ability to properly use the pMDI
    3. Body weight resulting in a Body Mass Index (BMI) between 18.0 and 30
    kg/m2
    4. Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine
    DBP 50- 90 mmHg, heart rate 50-90 bpm).
    5. Electrocardiogram (12 lead) with computerized protocol interpretation
    considered as normal (120 ms≤PR≤220ms, QRS≤120ms, QTc≤450ms).
    6. Stable COPD
    7. Decreased FEV1 between 30% and 50% predicted values (30% ≤FEV1 <
    50%) 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. FEV1/Forced Vital Capacity (FEV1/FVC) ≤ 70% documented at screening
    visit
    9. Reversibility of FEV1 < 12 % of the initial value 30 minutes after
    inhalation of 200µg Salbutamol within the screening period
    10. Treatment with any COPD medication at a constant dosage during the last
    4 weeks prior to inclusion
    11. Minimum smoking history of 10 pack-years (pack-years = the number of
    cigarette packs per day times the number of years)
    12. written informed consent
    E.4Principal exclusion criteria
    All subjects:
    1. Blood donation (equal or more than 450 ml) or blood loss less than 8
    weeks before the first intake of study drug
    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 ).
    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 an investigational drug study within 30 days prior to Visit 1
    or current participation in another investigational drug study
    10. Known sensitivity to Formoterol or Beclomethasone or any of the
    excipients contained in any of the formulations used in the trial.
    11. Concomitant severe diseases or diseases which are contra indications for
    the use of inhaled 2-agonist or steroids.
    12. Use of any prescription drug for which concomitant beta-agonist or steroid
    administration are contraindicated.
    13. History of significant sensitivity, allergy or intolerance to study drug
    formulation ingredients.
    14. Recent relevant infectious disease (less than two months)
    15. Flu vaccination within 4 weeks prior to the screening visit
    16. Other vaccination within 4 weeks prior to the screening visit


    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 2l/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 2l/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 deposition
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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 2006-12-12. 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
    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 Decision2007-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-05-04
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