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    Summary
    EudraCT Number:2015-004887-13
    Sponsor's Protocol Code Number:ADA113872
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-12-21
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-004887-13
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel Group study of ADVAIR™ DISKUS™ 100/50 and FLOVENT™DISKUS™ 100, both twice daily, in a Pediatric Population during the Fall Viral Season.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of ADVAIR DISKUS and FLOVENT DISKUS taken twice daily in children during fall viral season.
    A.4.1Sponsor's protocol code numberADA113872
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11-1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4408007839733
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    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 DISKUS
    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
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSALMETEROL XINAFOATE
    D.3.9.1CAS number 94749-08-3
    D.3.9.3Other descriptive nameSALMETEROL XINAFOATE
    D.3.9.4EV Substance CodeSUB04314MIG
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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 exploratory study was to assess whether treatment with FSC DISKUS 100/50 mcg twice-daily results in a clinically meaningful decrease in the risk of asthma exacerbations during the fall season when compared with the same dose of ICS in FP DISKUS 100 mcg twice daily.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Outpatient
    - Subjects must be between the ages of 4 and 11 at Randomization
    - Subjects must attend day-care, pre-school, elementary school, or middle school. Day-care attendance is defined as receiving childcare outside the home for at least 10 hours per week. Children who are home-schooled are not eligible for this study. Children on year round and traditional school calendars are eligible for this study.
    - Subjects can be randomized into this study at any time between August 2nd, 2010 and August 20th, 2010.
    - Males or pre-menarchal females.
    - A diagnosis of asthma, as defined by the National Institutes of Health [NIH, 2007]
    - At Visit 1 subjects must demonstrate a best clinic AM PEF ≥70% of the predicted value [Polgar, 1971].
    - Each subject must have a history of an exacerbation of asthma between September 1st, 2009 and May 15th, 2010 that required a burst of outpatient systemic corticosteroids (oral or parenteral on >1 days for worsening symptoms of asthma) or have had an urgent care, hospitalization, or ED visit for asthma during which they received oral/parenteral corticosteroids between September 1st, 2009 and May 15th, 2010.
    - Subjects must have prior or current use of controller ICS medication as listed below:
    -Subjects who have had prior use of a controller medication consisting of a low dose ICS at any time since September 1st, 2009 are eligible for inclusion in this study (refer to Table 1 for examples of allowed doses of commonly used ICS).
    -Subjects currently taking a low dose ICS are eligible for inclusion in the study (refer to Table 1 for examples of allowed doses of commonly used ICS).
    -Subjects’ currently taking a moderate dose ICS are eligible for inclusion in the study if the subject’s asthma has been controlled over the prior 3 months and the subject is a candidate for step down therapy, as defined by current asthma management guidelines [NIH, 2007].
    -Subjects’ currently taking low dose ICS in combination with a LABA are eligible for inclusion in the study if the subject’s asthma has been controlled over the prior 3 months and the subject is a candidate for step down therapy, as defined by current asthma management guidelines [NIH, 2007].
    E.4Principal exclusion criteria
    - History of Life Threatening Asthma
    - Unstable Asthma
    - Concomitant use of corticosteroid medication
    - Other Concurrent Diseases/Abnormalities: The known presence of sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within 4 weeks immediately preceding randomization that required the use of an antibiotic or was accompanied by symptoms of worsening asthma.
    - Concomitant Medications: Administration of any other prescription or over the counter medication which would significantly affect the course of asthma, such as omalizumab (Xolair), or interact with sympathomimetic amines, such as: anticonvulsants (barbiturates, hydantoins, carbamazepine), polycyclic antidepressants, beta-adrenergic blocking agents (both cardio-selective and non-selective), phenothiazines,
    - Cytochrome P450 3A4 (CYP 3A4) Inhibitors: A subject is not eligible if he/she is receiving a strong CYP 3A4 inhibitor within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole, itraconazole).
    - Immunosuppressive medications: A subject must not be using or require use of immunosuppressive medications (e.g. methotrexate, gold, cyclosporine, azathioprine) during the study.
    Note: Immunotherapy for the treatment of allergies is allowed during the study provided it was initiated 4 weeks prior to Visit 1 and the subject remains in the maintenance phase for the duration of the study.
    - Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, cystic fibrosis, dyspnea by any cause other than asthma, or other respiratory abnormalities other than asthma.
    - Other Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
    The list of additional excluded conditions/diseases includes, but is not limited to the following:
    Uncontrolled hypertension; Uncontrolled hematologic, hepatic, neurologic, or renal disease
    Uncontrolled gastroesophageal reflux disease, Immunologic compromise, Cardiac arrhythmias, Tuberculosis (current or untreated), Congestive heart failure, Cushing’s disease
    Coronary artery disease, Addison’s disease, Current malignancy, Eosinophilic esophagitis
    Uncontrolled diabetes mellitus, Uncontrolled thyroid disorder

    - Severe Hypersensitivity to Milk Proteins: Any immediate hypersensitivity reaction, such as urticaria, angioedema, rash, and bronchospasm to milk proteins
    - Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the Dry Powder Inhaler (i.e., lactose).
    - Tobacco Use: A history of or present use of any tobacco products.
    - Investigational Medications: A subject must not have participated in a study (including a non-interventional study) or used any investigational drug (including devices) within 30 days prior to Visit 1 or within ten half-lives (t1/2) of the prior investigational study (whichever is longer of the two).
    - Child in Care: A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The determination of whether a child meets the definition of CiC should be made with the study centre staff in consultation with the responsible IRB/Ethics Committee.
    - Affiliation with Investigator’s Site: A subject is an immediate family member of the participating investigator, sub investigator, study coordinator, or employee of the participating investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study was the number of exacerbations of asthma (defined above) during the double-blind treatment period. In addition, the time-adjusted relative risk of having an exacerbation was modeled.
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints included the severity and duration of asthma symptoms associated with moderate or severe upper respiratory symptoms or confirmed viral respiratory infection, the
    number of exacerbations associated with viral respiratory infection, the proportion of asthma-control days, episodefree, symptom-free, and rescue-free days.
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 weeks
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    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: 339
    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.1.1.5.1Number of subjects for this age range: 339
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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
    Paediatrics
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 339
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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