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    Summary
    EudraCT Number:2013-003373-10
    Sponsor's Protocol Code Number:M/34273/47
    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:2013-11-11
    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 number2013-003373-10
    A.3Full title of the trial
    A DOUBLE-BLIND, PLACEBO-CONTROLLED, 2 PERIOD CROSSOVER CLINICAL STUDY TO ASSESS THE EFFECT OF ACLIDINIUM BROMIDE 400 ΜCG BID ON COPD SYMPTOMS AND SLEEP QUALITY AFTER 3 WEEKS OF TREATMENT IN PATIENTS WITH STABLE MODERATE TO SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to evaluate the effect on COPD symptoms and sleep quality of aclinidimiun bromide 400mg twice daily in COPD patients.
    A.4.1Sponsor's protocol code numberM/34273/47
    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 SponsorALMIRALL S.A.
    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 supportAlmirall, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPAREXEL International GmbH
    B.5.2Functional name of contact pointEPD Berlin Germany
    B.5.3 Address:
    B.5.3.1Street AddressSpandauer Damm 130
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14050
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930306859505
    B.5.5Fax number+4930306857113
    B.5.6E-mailcorinna.brands@parexel.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 Yes
    D.2.1.1.1Trade name Eklira ® Genuair®
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall S.A.
    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.3.1Product nameAclidinium bromide
    D.3.2Product code LAS34273
    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 INNACLIDINIUM BROMIDE
    D.3.9.1CAS number 320345-99-1
    D.3.9.2Current sponsor codeLAS34273
    D.3.9.4EV Substance CodeSUB71687
    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.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
    Chronic Obstructive Pulmonary Disease
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease
    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 16.1
    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 assess the effect of aclidinium bromide vs placebo in improving the trough FEV1, COPD symptoms, sleep quality and physical activity after 3 weeks of treatment in patients with stable moderate and severe COPD.

    • To assess the safety and tolerability of aclidinium bromide 400 µg administered twice daily in the same target population.

    E.2.2Secondary objectives of the trial
    No secondary objectives are defined.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential will follow specific study requirements.
    2. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years.
    3. Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post bronchodilator FEV1 <80%, and FEV1 ≥ 30% at Screening Visit (Visit 1).
    4. Patient must be able to perform repeatable pulmonary function testing for FEV1 according to American Thoracic Society [ATS]/European Respiratory Society [ERS] 2005 criteria at Screening Visit. Focus is GOLD II and GOLD III.
    5. Patient who is eligible and able to participate in the study and who consents to do so in writing after the purpose and nature of the investigation have been explained.
    E.4Principal exclusion criteria
    1. History or current diagnosis of asthma.
    2. Patients with known current sleep apnoea.
    3. Patients who develop a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit (Visit 1) or during the run-in period.
    4. Clinically significant respiratory conditions.
    5. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.
    6. Patients who in the investigator's opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit.
    7. Use of long-term oxygen therapy (15 hours/day).
    8. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers.
    9. Clinically significant cardiovascular conditions.
    10. QTc (calculated according to Fridericia's formulae [QTc=QT/RR1/3]) above 470 milliseconds in the manual ECG reading performed at Screening Visit.
    11. Patient with clinically relevant abnormalities in the opinion of the investigator at the Screening Visit (Visit 1) in the results of the clinical laboratory tests, ECG parameters or in the physical examination.
    12. Patient with a history of hypersensitivity reaction to inhaled anticholinergics, long and short acting β2-agonists, sympathomimetic amines, or inhaled medication or any component there of (including report of paradoxical bronchospasm).
    13. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.
    14. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
    15. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer.
    16. Patient with any other serious or uncontrolled physical or mental dysfunction, or moderate to severe depression, as confirmed by Beck Depression Inventory (BDI-II) total score >28.
    17. Patient with a history (within 2 years prior to the Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment.
    18. Patient unlikely to be cooperative or that can't comply with the study procedures.
    19. Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to the Screening Visit.
    20. Patient who intends to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication.
    21. Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study.

    E.5 End points
    E.5.1Primary end point(s)
    There are no primary/secondary endpoints. Variables will be pulmonary function, COPD symptoms (early-morning, night-time, evening symptoms) and sleep endpoints assessed at the same level as exploratory.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline as well as at all visits, and continous throughout the study.
    E.5.2Secondary end point(s)
    There are no primary/secondary endpoints. Variables will be pulmonary function, COPD symptoms (early-morning, night-time, evening symptoms) and sleep endpoints assessed at the same level as exploratory.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the complete study period from first dosing until follow-up visit.
    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 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 No
    E.8.1.6Cross over Yes
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months7
    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 months7
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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)
    At the end of the study patients will be addressed to the physician to either keep up their previous treatment or to continue using the IMP.
    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 Decision2013-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-03
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