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    Summary
    EudraCT Number:2007-000135-26
    Sponsor's Protocol Code Number:2006-04-DOS-2
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-22
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2007-000135-26
    A.3Full title of the trial
    Double-blind, double-dummy, multi-center, randomized parallel group trial to demonstrate therapeutic equivalence of Salmeterol/Fluticasone MDI HEXAL (25 µg/50 µg per actuation) versus SeretideTM 50 (25 µg/50 µg per actuation) over a period of 12 weeks in pediatric patients aged 4-11 years with persistent moderate asthma
    A.4.1Sponsor's protocol code number2006-04-DOS-2
    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 SponsorHexal AG
    B.1.3.4CountryGermany
    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 nameSalmeterol/Fluticasone MDI HEXAL
    D.3.4Pharmaceutical form Inhalation vapour, 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 INNSALMETEROL XINAFOATE
    D.3.9.1CAS number 94749083
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474142
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeinhalative asthma drug
    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 Seretide TM 50 Evohaler TM
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK Limited, UK
    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.3.1Product nameSeretide TM 50 Evohaler TM
    D.3.4Pharmaceutical form Inhalation vapour, 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 INNSALMETEROL XINAFOATE
    D.3.9.1CAS number 94749083
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474142
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeinhalative asthma drug
    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 gas
    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 gas
    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
    Persistent, moderate asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003555
    E.1.2Term Asthma bronchial
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To show therapeutic equivalence of Salmeterol/Fluticasone MDI HEXAL (25 µg/50 µg per actuation) to SeretideTM 50 (25 µg/50 µg per actuation, Glaxo Wellcome UK Ltd.). Equivalence or non-inferiority will be concluded if the resulting 97.5% confidence interval for the difference between the two treatment groups with regard to the change in FEV1 (Visit 4 minus Visit 0) and the area under the 4-hour serial FEV1 curve (AUC0-4) at Visit 4 relative to baseline FEV1 (Visit 0) is completely contained within the acceptance ranges [ -12 %; ∞] and [ 80 %; ∞], respectively.
    E.2.2Secondary objectives of the trial
    Efficacy: Change in FEV1 from V0 to V2; Development of FEV1 and FEV1% over course of study; Change in morning pre-dose PEF from baseline to evaluation period; Development of the weekly morning and evening PEF and of FVC over course of study; Change in day/nighttime symptoms score over time; Frequency of reliever use, Incidence and severity of asthma exacerbations; #patients discontinuing the study due to asthma worsening; Overall assessment of efficacy
    Safety: Incidence/severity of AEs and drug related AEs; Morning serum cortisol at last study visit; 16-hour urinary free cortisol levels, Clin. relevant changes in lab parameters, vital signs, ECGs and physical exam parameters from V-1 to V 4; plasma levels of fluticasone and salmeterol at Visit 4; Incidence of oral candidiasis or voice hoarseness; Overall assessment of tolerability of the investigational product
    Additional: #days the child has been sick/needed home care and days missed by the parent(s) due to childcare
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Visit -1:
    1. Male or female children aged 4 to 11 years
    2. Written informed consent signed according to local requirements by one or by both patient’s parent(s) or legal representative prior to any protocol specific procedures
    3. Medical history of persistent moderate asthma (according to GINA) of at least 6 months duration
    4. Regular use of ICS or ICS plus LABA over the 6 months immediately prior to Visit -1
    5. Regular treatment with
    •medium- to high-dose ICS or medium-dose ICS plus LABA (children <5 years)
    •high-dose ICS or low- to medium-dose ICS plus LABA (children >=5 years)
    within the 4 weeks immediately prior to Visit -1
    6. Ability to perform spirometric maneuvers with a forced expiratory time of at least 1 second
    7. Patients aged 6-11 years capable of coordinating MDI actuation and inhalation
    8. FEV1 greater than 60% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for RABA and at least 12 hours for LABA
    9. Reversible and variable airflow limitation: At least 12% increase of FEV1 15-20 min after inhalation of 200 µg salbutamol. Reversibility has to be demonstrated at Visit -1 or needs to be documented by valid spirometric results obtained within 6 months prior to Visit -1
    10. Ability to read and write and to fill in the patient diary by the patient or by patient’s parent(s) or legal representative
    11. Ability to handle correctly the peak flow meter and the metered-dose inhalers with/without spacer
    At Visit 0:
    1. FEV1 greater than 60% and less than 80% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for RABA (reliever medication)
    2. FEV1 within +/- 15% of the value obtained at Visit -1
    3. At least 2 of the following criteria fulfilled during the last 7 days of the run-in period:
    3.1. Nighttime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 1 day
    3.2. Daytime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 3 days
    3.3. Use of RABA on at least 4 days
    E.4Principal exclusion criteria
    At V-1:
    1. Intermittent or persistent mild or severe asthma as defined by GINA
    2. Evidence of any active concomitant pulmonary disease other than asthma, i.e. chronic bronchitis
    3. Respiratory tract infection (including sinusitis) and middle ear infection within 4 weeks prior to Visit -1
    4. Acute asthma exacerbation within 4 weeks preceding Visit -1
    5. Acute asthma exacerbation requiring hospitalization or emergency room visit within 12 weeks preceding Visit -1
    6. History of life-threatening acute attacks or intubation for asthma
    7. History of seasonal asthma exacerbation
    8. History of paradoxical bronchospasm after inhaled asthma therapy
    9. Active or inactive lung tuberculosis
    10. Overdependence on RABA, i.e. frequency of RABA inhalation not consistent with persistent moderate asthma
    11. Patients naive for inhaled corticosteroids
    12. Change in asthma medication or regimen (other than inhalation of RABA) within 4 weeks preceding Visit -1
    13. Administration of cromones within 4 weeks preceding Visit -1
    14. Administration of oral corticosteroids within 4 weeks preceding Visit 1
    15. More than 2 courses of oral corticosteroids within the last 12 weeks
    16. Allergen-specific immunotherapy within the last 12 weeks
    17. Long-acting antihistamines within 1 week preceding Visit -1 (astemizole within 12 weeks)
    18. Use of beta-blockers or potent inhibitors of the cytochrome P450-3A4 system like ketoconazole, itraconazole, ritonavir within 4 weeks preceding Visit -1
    19. Vaccination with live-attenuated virus within 2 weeks preceding
    Visit -1
    20. Impaired adrenal cortex function
    21. Severe renal or hepatic disease
    22. Hypokalemia uncorrected and/or serum potassium value on Visit -1 less than 3.5 mmol/L
    23. Acute or history of severe cardiovascular disorders (e.g. heart rhythm abnormalities)
    24. Untreated or unstable hypertension
    25. Known diabetes
    26. Hyperthyroidism not adequately controlled
    37. Glaucoma
    28. History of hypersensitivity to one or both of the active ingredients or to any other component of the preparations or reliever medication
    29. Presence of any other severe decompensated concomitant disease (endocrine, hematological, neurological, immunological)
    30. Known active and significant pulmonary abnormalities as detected on chest radiographs
    31. Other relevant medical condition, ECG abnormality, or laboratory profile that might compromise the patient’s safety, compliance, or interfere with the evaluation or preclude completion as judged by the investigator or other contraindication to test drug.
    32. Females of childbearing potential, not willing to abstain from sexual activities throughout complete duration of participation in the study
    33. History of non-compliance with asthma management plan
    34. Current participation in another investigational drug study, or participation in any clinical study involving an investigational drug within 3 months prior to Visit -1
    35. Lack of sufficient co-operation or compliance or existing psychosocial problems
    36. Legal incapacity of the patient’s parent(s) or legal representative or other circumstances rendering the patient’s parent(s) or legal representative unable to understand the nature, scope and possible consequences of the study
    At V0:
    1. Acute respiratory tract infection during run-in period
    2. Severe asthma exacerbation during run-in period
    3. Any intake of asthma medication other than the inhalation of the supplied reliever medication during run-in period
    4. Use of more than 6 actuations of reliever medication on any single day during the run-in period
    E.5 End points
    E.5.1Primary end point(s)
    - FEV1 at the end of the 12-week study period (Visit 4) compared with baseline (Visit 0)
    - area under the 4-hour serial FEV1 curve (AUC0-4) at the end of the 12-week study period (Visit 4) relative to baseline FEV1 (Visit 0)
    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 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 Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    double-dummy
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 years0
    E.8.9.1In the Member State concerned months10
    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 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.1.1.1In 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) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 2007-04-22. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    As patients are younger than 12 years, parents(s) or legal guardian will have to sign the informed consent form.
    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 230
    F.4.2.2In the whole clinical trial 420
    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 Decision2007-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-05
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