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    Summary
    EudraCT Number:2010-023601-35
    Sponsor's Protocol Code Number:FpS-AS-202
    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:2012-10-08
    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 number2010-023601-35
    A.3Full title of the trial
    A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fp Spiromax® (Fluticasone Propionate Inhalation Powder) Administered Orally Twice Daily compared with Placebo in Adolescent and Adult Subjects with Severe Persistent Asthma Uncontrolled on High dose Inhaled Corticosteroid Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-Week Dose-ranging Study to Evaluate the Effectiveness and Safety of Fp Spiromax® given Orally Twice Daily compared with a non-active drug in Adolescent and Adult Subjects with Severe Persistent Asthma Uncontrolled on High dose Inhaled Corticosteroid Therapy.
    A.4.1Sponsor's protocol code numberFpS-AS-202
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTeva Branded Pharmaceutical Products R&D, Inc.
    B.1.3.4CountryUnited States
    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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Branded Pharmaceutical Products R&D, Inc.
    B.5.2Functional name of contact pointTeva Global Respiratory R&D
    B.5.3 Address:
    B.5.3.1Street Address425 Privet Road
    B.5.3.2Town/ cityHorsham
    B.5.3.3Post code19044
    B.5.3.4CountryUnited States
    B.5.6E-mailTevaRespiratoryStudies@tevausa.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 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 nameFluticasone Spiromax or Fp Spiromax
    D.3.4Pharmaceutical form Inhalation powder
    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 INNFluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    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) 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.IMP: 2
    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 nameFluticasone Spiromax or Fp Spiromax
    D.3.4Pharmaceutical form Inhalation powder
    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 INNFluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    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) 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.IMP: 3
    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 nameFluticasone Spiromax or Fp Spiromax
    D.3.4Pharmaceutical form Inhalation powder
    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 INNFluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 4
    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 nameFluticasone Spiromax or Fp Spiromax
    D.3.4Pharmaceutical form Inhalation powder
    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 INNFluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.IMP: 5
    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 Flovent Diskus
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Smithkline
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameFlovent Diskus
    D.3.4Pharmaceutical form Inhalation powder
    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 INNFluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    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
    Severe Persistent 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high dose ICS therapy.
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent/assent: For adult patients, written informed
    consent signed and dated by the patient before conducting any study
    related procedures; for minor patients, written informed consent signed
    and dated by the parent/legal guardian and written assent signed and
    dated by the patient before conducting any study related procedure.
    2. Male or female 12 years and older, as of the Screening Visit. Male or
    female 18 years and older, as of the Screening Visit, in countries where
    local regulations or the regulatory status of study medication permit
    enrollment of adults only.
    3. General good health, free of any concomitant conditions or treatment
    that could interfere with study conduct, influence the interpretation of
    study observations/results, or put the subject at increased risk during
    the study.
    4. Asthma Diagnosis: Asthma as defined by the National Institutes of
    Health.
    5. Severity of Disease: A best forced expiratory volume in one second
    (FEV1) of 40%-85% of the predicted normal value during the Screening
    Visit. NHANES III predicted values will be used for subjects aged ≥12
    years and adjustments to predicted values will be made for African
    American subjects. American Thoracic Society (ATS)/European
    Respiratory Society (ERS) 2005 criteria for acceptability, repeatability,
    and end of test must be met for spirometry.
    6. Reversibility of Disease: Demonstrated a ≥12% reversibility of FEV1
    within 30 minutes following 2-4 inhalations of albuterol/salbutamol
    inhalation aerosol (if required, spacers and nebulized albuterol are
    permitted for reversibility testing only) at the Screening Visit. If subjects
    fail to demonstrate an increase in FEV1 ≥12% then subjects are not
    eligible for the study; however, based on investigator judgment, they
    will be allowed to retest once within 7 days and rescreen once after 7
    days. Reversibility values of 11.50 – 11.99 will be rounded to 12.
    Documented historical reversibility of ≥ 12% within 1 year of the
    Screening Visit will be accepted.
    7. Current Asthma Therapy: Subjects will be required to be on a short
    acting β2 agonist and inhaled corticosteroid for a minimum of 8 weeks
    before the Screening Visit and have been maintained on a stable dose of
    inhaled corticosteroids (either as ICS mono or as ICS/LABA combination
    therapy) for 4 weeks prior to the Screening Visit at 1 of the following
    qualifying ICS doses (see protocol for details of qualifying doses).
    8. Short-Acting β2-Agonists: All subjects must be able to replace their
    current short-acting β2-agonists with albuterol/salbutamol inhalation
    aerosol at the Screening Visit for use as needed for the duration of the
    study. The use of spacer devices with the metered dose inhaler (MDI)
    will not be allowed during the study with exception of it's use during
    reversibility testing at the Screening Visit. Nebulized
    albuterol/salbutamol will not be allowed at any time during the study.
    Subjects must be able to withhold all inhaled short-acting β2
    sympathomimetic bronchodilators for at least 6 hours prior to all study
    visits.
    9. If female, is currently not pregnant, breast feeding, or attempting to
    become pregnant, has a negative serum pregnancy test, and is of
    • Non-childbearing potential, defined as:
    - Before menarche, or
    - ≥1 year post-menopausal, or
    - Surgically sterile (tubal ligation, bilateral oophorectomy, or
    hysterectomy), or
    - Congenital sterility, or
    - Diagnosed as infertile & not undergoing treatment to reverse infertility
    or is of
    • Child-bearing potential, willing to commit to using a consistent and
    acceptable method of birth control as defined below for the duration of
    the study:
    - Systemic contraception used for ≥1 month prior to screening, including
    birth control pills, transdermal patch (Ortho Evra®), vaginal ring
    (NuvaRing®), levonorgesterel (Norplant®), or injectable progesterone
    (Depo-Provera®), or
    - Double barrier methods (condoms, cervical cap, diaphragm, & vaginal
    contraceptive film with spermicide), or
    - Intrauterine device (IUD)
    - Monogamous with a vasectomized male partner
    or is of
    • Child-bearing potential & not sexually active, willing to commit to
    using a consistent & acceptable method of birth control as defined above
    for the duration of the study, in the event the subject becomes sexually
    active
    10. Capable of understanding the requirements, risks, and benefits of
    study participation, &, as judged by the investigator, capable of giving
    informed consent/assent & being compliant with all study requirements
    (visits, record-keeping, etc).
    See Protocol Document Appendix C (pages 115-133) for complete
    summary of changes.
    E.4Principal exclusion criteria
    1. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation &/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
    2. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit and the Randomization Visit.
    3. Any asthma exacerbation requiring oral corticosteroids within 1 month of the Screening Visit. A subject must not have had an emergency room visit or hospitalization for asthma within 2 months prior to the Screening Visit.
    4. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
    5. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, Cushing’s syndrome), gastrointestinal (e.g poorly-controlled peptic ulcer, GERD), or pulmonary (e.g chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease).
    6. Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to:
    • Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for 1 year prior to the Screening Visit.
    • Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years
    • Uncontrolled hypertension (systolic BP ≥160 or diastolic BP >100)
    • Stroke within 3 months prior to the Screening Visit
    • Immunologic compromise
    7. History of a positive test for HIV, hepatitis B or hepatitis C infection.
    8. Untreated oral candidiasis at the Screening Visit. Subjects with clinical visual evidence of oral candidiasis and who agree to receive treatment and comply with appropriate medical monitoring may enter the study.
    9. History of any adverse reaction to any intranasal, inhaled or systemic corticosteroid therapy. Known/suspected sensitivity to the constituents of the dry powder inhalers used in the study (i.e lactose).
    10. History of severe allergy to milk protein.
    11. Use of systemic, oral or depot corticosteroids within 4 weeks prior to the Screening Visit
    • Use of topical corticosteroids (≤1% hydrocortisone cream) for dermatological disease is permitted
    • Use of intranasal corticosteroids or ocular corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit and throughout the study is permitted
    12. Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study.
    13. Immunotherapy for the treatment of allergy at a stable maintenance dose for at least 90 days prior to the Screening Visit and which will remain at a stable dose without escalation throughout the study is permitted.
    14. Use of Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit. Strong and moderate CYP3A4 inhibitors are prohibited and weak CYP3A4 are allowed
    15. History of alcohol or drug abuse within 2 years preceding the Screening Visit.
    16. Current smoker or a smoking history of 10 pack years or more. A subject may not have used tobacco products within the past one year (e.g cigarettes, cigars, chewing tobacco, or pipe tobacco).
    17. Study participation by clinical investigator site employees &/or their immediate relatives.
    18. Study participation by more than 1 subject from the same household at the same time. However, after the study completion or discontinuation by one subject another subject from the same household may be screened.
    19. Participation in any investigational drug study within the 30 days (starting at the final follow-up visit) preceding the Screening Visit or planned participation in another investigational drug study at any time during this study.
    20. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject’s last study related visit (for eligible subjects only – if applicable). Eligible female subjects unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is:
    • Change from baseline in trough (AM pre-dose and pre-rescue bronchodilator) FEV1 over the 12-week Treatment Period
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is:
    • Change from baseline in trough (AM pre-dose and pre-rescue bronchodilator) FEV1 over the 12-week Treatment Period
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoint:
    • Change from baseline in weekly average of daily trough (pre-dose and pre-rescue bronchodilator) AM PEF over the 12-week Treatment Period
    • Change from baseline in weekly average of daily PM PEF over the 12-week Treatment Period
    • Time to withdrawal due to meeting stopping criteria for worsening asthma during the 12-week Treatment Period
    • Change from baseline in the percentage of rescue-free 24-hour periods during the 12-week Treatment Period
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Change from baseline in weekly average of daily trough (pre-dose and pre-rescue bronchodilator) AM PEF over the 12-week Treatment Period
    • Change from baseline in weekly average of daily PM PEF over the 12-week Treatment Period
    •Time to withdrawal due to meeting stopping criteria for worsening asthma during the 12-week Treatment Period
    • Change from baseline in the percentage of rescue-free 24-hour periods during the 12-week Treatment 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 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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    The study is double blind for doses of Fp Spiromax vs placebo but the comparator arm is open label
    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.8.2.3.1Comparator description
    Flovent Diskus
    E.8.2.4Number of treatment arms in the trial6
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bulgaria
    Croatia
    Germany
    Hungary
    Ireland
    Israel
    Poland
    Puerto Rico
    Romania
    Serbia
    South Africa
    Spain
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    LVLS
    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.1.1Number of subjects for this age range: 56
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 56
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 532
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 600
    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)
    Patient will continue on normal standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-09
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