Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-002157-23
    Sponsor's Protocol Code Number:2007-FOR-EL-02
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-24
    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 ConcernedGreece - EOF
    A.2EudraCT number2007-002157-23
    A.3Full title of the trial
    A 8-week, multicentre, randomized, double-blind, double-dummy, parallel group, non-inferiority study, comparing Formoterol (Formopen®) administered via Elpenhaler® Dry Powder Inhaler versus the innovative Formoterol (Foradil®) administered via Aerolizer® in patients with mild to moderate persistent asthma.
    A.4.1Sponsor's protocol code number2007-FOR-EL-02
    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 SponsorElpen Pharmaceutical Co. Inc.
    B.1.3.4CountryGreece
    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 Formopen
    D.2.1.1.2Name of the Marketing Authorisation holderElpen Pharmaceutical Co. Inc
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 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 INNFormoterol fumarate
    D.3.9.1CAS number 43229-80-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 Foradil
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 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 INNFormoterol fumarate
    D.3.9.1CAS number 43229-80-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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
    D.8 Placebo: 2
    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
    Patients with mild to moderate persistent asthma, as defined by GINA criteria
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess therapeutic equivalence of the new generic 12µg dry powder formoterol formulation (Formopen®) compared to the reference formoterol formulation (Foradil®).
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of the new generic 12µg dry powder formoterol formulation.
    To evaluate the sustained bronchodilation of the new generic 12µg dry powder formoterol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Study subjects are eligible for participation if they meet all of the following criteria:
    At study entry
    Visit 1 - Screening visit
    1. Male or female subjects aged from 18 to 65 years old
    2. Subject has signed the written informed consent
    3. Documented history of mild to moderate persistant asthma (according to GINA criteria in Appendix 2) of ≥ 6 months at the screening visit
    4. Concurrent use of a short acting inhaled β2-agonist for symptom relief and inhaled corticosteroids as maintenance treatment
    5. Have an FEV1 >60% of the predicted normal FEV1 after withholding short-acting inhaled β2-agonists for at least 6 hours and long-acting β2-agonists for at least 24 hours
    6. Demonstrate at study entry airway reversibility (increase in FEV1 >12% of the pre-medication value and an absolute increase of at least 0.200 lt) 15 minutes after the inhalation of 400 μg salbutamol, after withholding short-acting inhaled β2-agonists for at least 6 hours and long-acting β2-agonists for at least 24 hours
    7. Have a PIF between 30 and 90 Lt/min measured with the InCheck (Clement Clark, UK) device
    8. Able to use both types of inhalers with a satisfactory technique
    9. Able to use a peakflow meter correctly and can produce reliable PEFR readings
    10. In the opinion of the investigator, subjects are able to fill and maintain a diary card, to fill a Questionnaire related to the usability of the inhalers, and understand the procedure of the specific trial.

    At baseline visit
    Visit 2- Randomisation visit

    1. Have FEV1 of at least 60% of the predicted value for age, height and gender after withholding for 6 hours from short acting β2-agonists and from long acting agonists for the duration of the baseline period (at least 14 days plus a maximum of 3 days).
    2. Demonstrate airway reversibility (increase in FEV1 >12% of the predicted value and an absolute increase of at least 0.200 lt) 15 minutes after the inhalation of 1 dose of 12 μg formoterol (study medication), after withholding short-acting inhaled β2-agonists for at least 6 hours and long-acting β2-agonists for the duration of the baseline period.
    E.4Principal exclusion criteria
    Patients who meet any of following exclusion criteria are not eligible for randomisation into the study:

    At study entry
    Visit 1- Screening visit
    1. Patients receiving oral corticosteroid therapy or who have received oral corticosteroid therapy in the 3 months prior to the start of this study, or who have received more than 3 short courses (up to 5 days each) of oral corticosteroid therapy in the last year
    2. Patients currently receiving any of the following medications
    a. anticholinergics
    b. theophylline or methylxanthines
    c. cromones
    d. mono-amino oxidase inhibitors or tricyclic antidepressants
    e. use of oral or topical beta-blockers agents (like antihypertensive drugs or eye drops)
    f. use of leukotriene antagonists, either currently or during the last week preceding the screening visit
    3. Patients currently receiving therapy for an upper respiratory tract infection
    4. Patients who have been hospitalized or received emergency treatment for an exacerbation of asthma in the 3 months prior to the start of the study
    5. Patients with a known or suspected hypersensitivity to formoterol, salbutamol or lactose
    6. Heavy smokers (> 10 cigarettes per day) or ex smokers who smoked more than 10 packs years
    7. Patients with any of the following concurrent conditions
    a. uncontrolled diabetes melitus
    b. evidence or history of neoplastic disease other than adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the uterine cervix
    c. evidence or history of tuberculosis
    d. evidence or history of ischaemic heart disease, severe heart failure, myocardial infarction, tachyarrhythmias, cardiac arrhythmias, third degree atrioventricular block, decompensated heart failure, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe hypertension, prolongation of the QTc>0.44s, aneurysm, convulsive disorders, thyreotoxicosis, pheochromocytoma.
    e. respiratory disorders other than asthma or rhinitis
    f. clinically significant hepatic (transaminase level more than 2 times higher than the normal values) or renal disease (creatinine clearance less than 10 ml/min)
    g. evidence of history of alcohol or drug abuse
    8. Female patients that are pregnant or lactating. Women of childbearing potential that refuse to take adequate contraceptive precautions
    9. In the opinion of the investigator, patients who are unlikely to be compliant, take their medication as directed, complete the diary card or attend scheduled clinic visits as required
    10. Patients currently receiving other investigational drugs or who have received investigational medication in the month prior to the start of the study
    11. Patients previously randomized into this study
    12. Employees of Elpen or CROs or hospitals or any other organization involved in the study

    Visit 2-At baseline visit
    1. Patients with a pre-dose FEV1 variation more than + 15% of the respective FEV1 measured in the previous visit.
    2. Use of oral or topical long acting β2 agonists during the baseline period
    3. Patients currently receiving therapy for an upper respiratory tract infection or who have received such a treatment in the month prior to visit 2
    4. Poor compliance during the run-in period
    E.5 End points
    E.5.1Primary end point(s)
    The primary study variable will be the change of mean mPEFR as defined by the following variables: mean mPEFR at baseline and mean mPEFR at the end of study period.
    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 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) 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 Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 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) 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 185
    F.4.2.2In the whole clinical trial 200
    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 Decision2007-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-15
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 18:14:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA