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    The EU Clinical Trials Register currently displays   44132   clinical trials with a EudraCT protocol, of which   7324   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).

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    Summary
    EudraCT Number:2014-001053-16
    Sponsor's Protocol Code Number:D2550C00005
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-001053-16
    A.3Full title of the trial
    A 12-week Phase IIa, Double-blind, Placebo-controlled, Randomized Study to Investigate the Efficacy and Safety of AZD7624 in COPD Patients with a History of Frequent Acute Exacerbations while on Maintenance Therapy
    Een 12-weeks, fase 2a, dubbelblind, placebogecontroleerd, gerandomiseerd onderzoek naar de effectiviteit en veiligheid van AZD7624 bij patiënten met COPD en frequente, acute exacerbaties tijdens gebruik van onderhoudsmedicatie in de voorgeschiedenis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-week study to investigate the effect and safety of AZD7624 treatment compared to placebo (inactive substance) in COPD Patients when administered together with the patients' regular COPD Therapy
    Een 12-weeks onderzoek naar de effectiviteit en veiligheid van AZD7624 vergeleken met placebo bij patiënten met COPD en frequente, acute exacerbaties tijdens gebruik van onderhoudsmedicatie in de voorgeschiedenis
    A.4.1Sponsor's protocol code numberD2550C00005
    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.1.3.4CountrySweden
    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 Centre
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.centre@astrazeneca.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 nameAZD7624 inhal. sol. 2-20 mg/mL, ADI delivery unit
    D.3.2Product code AZD7624 inhal. sol. 2-20 mg/mL, ADI delivery unit
    D.3.4Pharmaceutical form Inhalation solution
    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 INNNA
    D.3.9.1CAS number 1095004-78-6
    D.3.9.2Current sponsor codeAZD7624
    D.3.9.3Other descriptive nameAZ12902847
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 20
    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 solution
    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.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effects of AZD7624 vs. placebo on the time to first event of moderate or severe COPD exacerbation or early drop-out related to worsening of COPD symptoms (i.e. composite endpoint referred to as “ExDo”) in patients with COPD on maintenance treatment with at least ICS/LABA.
    E.2.2Secondary objectives of the trial
    To compare the effects of AZD7624 vs. placebo as add-on to COPD maintenance treatment with at least ICS/LABA in patients with COPD on:
    -Number of moderate and severe COPD exacerbations and early drop-outs related to worsening of COPD symptoms
    -Time to first event of moderate or severe COPD exacerbations or early drop-out (including drop-outs due to any cause)
    -Number of moderate and severe COPD exacerbations and early drop-outs (including drop-outs due to any cause)
    -Time to first and number of moderate or severe exacerbations
    -Time to first and number of symptom defined exacerbations
    -Pulmonary function measured as changes from baseline in trough FEV1, FVC and FEV1/FVC
    -Health related quality of life
    -Dyspnea
    To evaluate the pharmacokinetic profile of AZD7624 in patients with COPD on maintenance treatment with at least ICS/LABA.
    To evaluate the safety and tolerability of AZD7624 vs. placebo in patients with COPD on maintenance treatment with at least ICS/LABA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated written informed consent prior to any study specific procedures
    2. Male and females aged 40 - 85 years
    3. Females must have a negative pregnancy test at Visit 1, must not be lactating and must be of non-childbearing potential, by fulfilling one of the following criteria:
    -Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all possible exogenous hormonal treatments and luteinising hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range (at Visit 1)
    6. Clinical diagnosis of COPD for more than 1 year at Visit 1, according to the GOLD 2014 guidelines
    7. Stable COPD maintenance treatment with at least ICS/LABA for at least 2 months prior to enrolment (Visit 1), to be continued unchanged during the study
    8. A post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator FEV1 ≤70% of the predicted normal value (at Visit 2)
    9. Documented history of 2 or more moderate to severe COPD exacerbations (requiring treatment with systemic corticosteroid and/or with antibiotics and/or emergency room visit and/or hospitalisation) within 12 months of randomisation (Visit 3), but not within the last 6 weeks before randomisation (Visit 3). At least one of the exacerbations should be while on current COPD maintenance therapy (at least ICS/LABA)
    .
    E.4Principal exclusion criteria
    1. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at third party vendor or at the investigational sites)
    2. Previous randomisation to treatment in the present study (at Visit 1)
    3. Participation in another clinical study with any novel investigational medicinal product within 3 months before the first dose of investigational product in this study (at Visit 3)
    4. Previously intake of any p38 inhibitor (same class as AZD7624)
    5. Participation in, or scheduled for an intensive COPD rehabilitation programme at any time during the study (N.B. patients are allowed to be in the maintenance phase of a rehabilitation programme)
    6. Planned in-patient surgery or hospitalisation during the study
    7. Significant disease or disorder other than COPD (e.g. cardiovascular; pulmonary as e.g. tuberculosis and cystic fibrosis; gastrointestinal, liver; neurological; musculoskeletal; endocrine; metabolic; malignant; psychiatric; major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient’s ability to participate in the study (at Visit 1)
    8. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines (GINA 2013) or other accepted guidelines. Patients with a past medical history of asthma (e.g. childhood or adolescence) may be included
    9. Any clinically relevant abnormal findings in clinical chemistry, haematology and urinalysis, which, in the opinion of the investigator, may put the patient at risk because of participation in the study (at Visit 2 and 3)
    11. Any clinically relevant abnormal findings in physical examination, pulse or blood pressure which, in the opinion of the investigator, may put the patient at risk because of participation in the study (at Visit 1, 2 and 3)
    12. Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV)
    13.History or family history of muscle diseases (at Visit 1)
    14.Abnormal vital signs, after 10 minutes supine rest, defined as any of the following (at Visit 1, 2 and 3):
    -Systolic blood pressure (SBP) above 150 mmHg
    -Diastolic blood pressure (DBP) above 90 mmHg
    -Pulse <40 or >100 bpm
    15.Prolonged QTcF >450 ms or family history of long QT syndrome or sudden death at young age. PR(PQ) interval prolongation of clinical significance, PR(PQ) > 250 ms. Intermittent second or third degree atrioventricular (AV) block, or AV dissociation. QRS duration ≥120ms. Patients who are not in sinus rhythm. Patients with persistent, and /or recurrent symptomatic tachyarrhythmias, as well as patients with an implantable cardioverter-defibrillator (ICD) or a permanent pacemaker. Patients on anticoagulation treatment.
    16.Unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society (CSS) class 2. History of hospitalisation within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) class II. Acute myocardial infarction within 6 months of screening (Visit 1).
    17. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624
    18. Any exacerbation (defined as use of systemic glucocorticosteroids (GCS) and/or antibiotics and/or emergency room visit and/or hospitalisation related to COPD) or respiratory infection within 6 weeks of randomisation (Visit 3)
    19. Plasma donation within one month of Visit 1, or any blood donation/blood loss >500 mL during the 3 months prior to Visit 1
    20. History of, or current alcohol or drug abuse, or any condition associated with poor compliance, as judged by the investigator
    21. Treatment with depot GCS within 12 weeks of randomisation (Visit 3). Treatment with any other GCS within 6 weeks of Visit 3 regardless of indication
    22. Treatment with moderate and strong CYP3A inhibitors (like erythromycin and itraconazole), within 4 weeks prior to randomisation (Visit 3).
    Any of the following is regarded as a criterion for exclusion from the genetic research:
    23. Previous bone marrow transplant
    24. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the PGx sample collection.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first event of moderate or severe COPD exacerbation or early drop-out
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout study treatment period (12 weeks treatment)
    E.5.2Secondary end point(s)
    Number of moderate to severe COPD exacerbations or early drop-outs

    Time to first event of moderate to severe COPD exacerbations or early drop-out (including drop-outs due to any cause)

    Trough FEV1, FVC and FEV1/FVC

    Time to first symptom defined exacerbation (as defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] daily diary)

    Number of and time to first symptom defined exacerbations (as defined by the EXACT daily diary)
    Symptoms of COPD (using the EXACT for Respiratory Symptoms [E-RS], a subset of items from the EXACT diary)

    Health related quality of life (as assessed by SGRQ-C)

    Dyspnea (as assessed by BDI/TDI score)

    AUC, Cmax, t1/2

    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout study treatment period (12 weeks treatment)
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned4
    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 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
    Argentina
    Chile
    Germany
    Netherlands
    South Africa
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last visit of the last patient undergoing the trial
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 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: 162
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 212
    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)
    No difference from the expected normal treatment of Chronic Obstructive Pulmonary Disease
    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 Decision2014-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
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