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    Summary
    EudraCT Number:2016-004655-75
    Sponsor's Protocol Code Number:D5970C00002
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-004655-75
    A.3Full title of the trial
    A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Glycopyrronium/Formoterol Fumarate fixed-dose combination relative to Umeclidinium/Vilanterol fixed-dose combination over 24 Weeks in patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (AERISTO)
    Étude multicentrique de phase IIIb, randomisée, en double aveugle et double-placebo, en groupes parallèles, évaluant l’efficacité et la
    tolérance de l'association fixe glycopyrronium/fumarate de formotérol comparée à celle de l’association fixe umeclidinium/vilanterol sur une
    période de 24 semaines chez des patients atteints de BPCO modérée à très sévère (AERISTO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Glycopyrronium/Formoterol Fumarate fixed-dose combination relative to Umeclidinium/Vilanterol fixed-dose combination over 24 Weeks in patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
    A.3.2Name or abbreviated title of the trial where available
    Aeristo
    A.4.1Sponsor's protocol code numberD5970C00002
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySpain
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilmington, DE
    B.5.3.3Post code19850-5437
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018003369933
    B.5.6E-mailInformation.Center@astrazaneca.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 name7.2 mcg glycopyrronium/4.8 mcg formoterol fumarate per actuation
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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 INNGlycopyrronium Bromide
    D.3.9.1CAS number 596-51-0
    D.3.9.3Other descriptive nameGLYCOPYRRONIUM BROMIDE
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.2
    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.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.8
    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 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 Anoro Ellipta
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code R03AL03
    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 INNUMECLIDINIUM BROMIDE
    D.3.9.1CAS number 869113-09-7
    D.3.9.4EV Substance CodeSUB119778
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVILANTEROL
    D.3.9.1CAS number 503070-58-4
    D.3.9.4EV Substance CodeSUB77409
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboPressurised inhalation, suspension
    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
    Chronic obstructive pulmonary disease (COPD)
    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
    To assess the effects of GFF relative to UV on lung function as measured by trough FEV1 in patients with moderate to very severe COPD
    E.2.2Secondary objectives of the trial
    1. To further assess the effects of GFF relative to UV on lung function.
    2. To assess the effects of GFF relative to UV on dyspnea
    3. To assess the effects of GFF relative to UV on symptoms of COPD
    4. To assess the effects of GFF relative to UV on health-related quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Female or male patients aged 40-95 years inclusive at the time of enrolment at screening
    3. Tobacco Use: Current or former smoker with a history of at least 10 pack-years of cigarette smoking (1 pack year = 20 cigarettes smoked per day for 1 year)
    4. A current clinical diagnosis of COPD, with COPD symptoms for more than 1 year prior to screening, as defined by GOLD criteria or other current guidelines
    5. COPD Severity defined as:
    - At screening visits, post-bronchodilator FEV1/FVC ratio <0.70, FEV1 <80% of predicted normal value, and FEV1 ≥750 mL if FEV1 is <30% of predicted normal value
    - At randomisation, FEV1/FVC ratio <0.70 and FEV1 <80% of predicted normal value in both pre-dose assessments
    6. COPD treatment with rescue medication only, or stable dose of maintenance monotherapy (LAMA, LABA or ICS), or stable dose of double maintenance therapy (LAMA/LABA or ICS/LABA), for one month prior to screening. Triple maintenance therapy (LAMA/LABA/ICS) is not allowed for one month prior to screening. Stepping-down from triple maintenance therapy before the month prior to screening must only be based on clinical symptoms in the opinion of the Investigator
    7. COPD symptom severity: CAT ≥10 at screening for patients on rescue medication only or maintenance monotherapy. No symptom requirement at screening for patients on double maintenance therapy. CAT ≥10 at randomisation for all patients
    8. Patient is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol
    9. Documentation of a chest x-ray (as per local practice) or computed tomography (CT) within 6 months prior to screening, with no clinically significant pulmonary abnormalities other than related to COPD
    - Specific to countries with restrictive radiology assessment practice: if no documentation of chest x-ray or CT of the chest/lungs within 6 months prior to screening is available, an MRI may be used instead, as per local practice assessment, or the Investigator may follow local guidelines to have the chest x-ray or CT approved
    10. Ability and willingness to comply with all study procedures, including daily completion of ePRO
    E.4Principal exclusion criteria
    1. Respiratory disease:
    - Current diagnosis of asthma
    - Alpha-1 Antitrypsin Deficiency as the cause of COPD
    - Other respiratory disorders: active tuberculosis, lung cancer, clinically significant bronchiectasis disease, sarcoidosis, IPF, primary pulmonary hypertension, or uncontrolled sleep apnea
    - Patients who have undergone lung volume reduction surgery, lobectomy or bronchoscopic lung volume reduction in 1yr of screening
    - Severe COPD exacerbation (resulting in hospitalisation) not resolved in 8wk prior to screening, or moderate not resolved in 4wk, or moderate or severe during screening
    - Pneumonia or lower respiratory tract infection that required antibiotics in 8wk prior to or during screening
    - Risk factors for pneumonia: immune suppression (HIV), severe neurological disorders affecting control of the upper airway or other risk factors that would put patients at substantial risk of pneumonia
    - Patients receiving long-term-oxygen therapy or nocturnal oxygen therapy required>12h/day
    - Patient use of any non-invasive positive pressure ventilation device. Note: Patients using continuous positive airway pressure or bi-level positive airway pressure for sleep apnea syndrome are allowed if not used for ventilatory support
    - Patients who have participated in the acute phase of a pulmonary rehabilitation in 4wk prior to screening or who will enter the acute phase of a pulmonary rehabilitation during screening. Allowed in the maintenance phase
    2. Cardiac disease:
    - Unstable angina/acute coronary syndrome, or CABG, PCI or myocardial infarction within the past 6 months.
    - CHF NYHA class III/IV
    - Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease)
    - Paroxysmal (in past 6mths) or symptomatic chronic cardiac tachyarrhythmia
    - LBB or high-degree AV block (2 and 3 degree) unless using pacemaker
    - Sinus node dysfunction with pauses
    - Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome
    - QTcF interval >470 msec (corrected using Fridericia's formula)
    - Any other ECG abnormality deemed clinically significant
    - Bradycardia with ventricular rate <45bpm
    - Uncontrolled hypertension >165/95mmHg
    3. Patients with a calculated eGFR <30mL/min using CKD-EPI formula
    4. Patients who have cancer that has not been in complete remission for at least 5yrs
    5. Patients with a diagnosis of narrow-angle glaucoma that hasn't been adequately treated. All medications approved for control of intraocular pressures are allowed
    6. Patients with symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant
    7. Significant diseases or conditions other than COPD which may put the patient at risk, influence the results of the study or the patient's ability to participate
    8. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalyses, vital signs or ECG which may put the patient at risk
    9. Pregnant or lactating women, or if planning to become pregnant during the study, or women of childbearing potential who are not using an acceptable method of contraception
    10. Patients who have a history of hypersensitivity to β2 agonists, GP or other muscarinic anticholinergics, or any component of the MDI or DPI
    11. Patients who abuse alcohol or drugs
    12. Patients who are medically unable to withhold their short-acting bronchodilators for 6h prior to spirometry at study visits
    13. Patients who would be unable to abstain from protocol-defined prohibited medications during screening and treatment
    14. Patients unable to comply with study procedures during screening, including non-compliance (<70%) with ePRO completion
    15. Site staff or their immediate family
    16. Patients with a history of psychiatric disease, intellectual deficiency, poor motivation, substance abuse, or other conditions that will limit the validity of informed consent to participate in the study as judged by Investigator
    17. Treatment with IP or device in another clinical study within the last 30d or 5 1/2-lives prior to screening, whichever is longer. Note: Patient participation in observational studies is not exclusionary
    18. Patients who have needed additions or alterations to their usual maintenance therapy for COPD due to worsening symptoms within 1 mth prior to and during screening
    19. Treatment with depot corticosteroids within 6wk, and other systemic corticosteroids within 4 wk, prior to screening. Except patients who are steroid dependent, and maintained on an equivalent of 5mg prednisone per day, or 10mg every other day, for at least 3mths prior to screening, provided stable dose during screening
    20. Any monoclonal or polyclonal antibody therapy taken for any reason within 6mths prior to screening
    21. Planned hospitalisation or significant surgical procedure during the study
    22. Involvement in the planning and/or conduct of study (both sponsor and study site)
    23. Previous randomisation in the present study
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in morning pre-dose trough FEV1 (Forced Expiratory Volume in 1 second)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks of treatment
    E.5.2Secondary end point(s)
    Onset of action on day 1; proportion of patients with increase of FEV1 of ≥100 ml from baseline at 5 minutes
    Change from baseline in Peak FEV1 within 2 hours post-dosing
    Change from baseline in Peak Inspiratory Capacity (IC) within 2 hours post-dosing
    Transition Dyspnea Index (TDI) focal score
    Change from baseline in Early Morning Symptoms COPD Instrument (EMSCI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 minutes on Day 1 for early onset, 24 weeks for all other endpoints
    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 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 Yes
    E.8.2.3.1Comparator description
    Umeclidinium/Vilanterol fixed-dose combination
    E.8.2.4Number of treatment arms in the trial2
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Bulgaria
    Canada
    France
    Hungary
    Russian Federation
    Ukraine
    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
    The last visit of the last patient undergoing the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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.1.2.1Number of subjects for this age range: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 1000
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-04
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