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    Summary
    EudraCT Number:2008-006886-10
    Sponsor's Protocol Code Number:M/34273/23
    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:2008-12-30
    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 number2008-006886-10
    A.3Full title of the trial
    A multiple dose, double blind, double-dummy, two-week 3 way cross-over, placebo-controlled clinical trial to assess the efficacy and safety of twice daily inhaled Aclidinium-bromide 400 µg compared to placebo and to an active comparator in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD)
    A.4.1Sponsor's protocol code numberM/34273/23
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratorios Almirall, 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAclidinium Bromide
    D.3.2Product code LAS34273
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Spiriva
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nametiotropium
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTiotropium Bromide
    D.3.9.1CAS number 139404-48-1
    D.3.9.3Other descriptive nametiotropium
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder, hard capsule
    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
    patients with stable moderate to severe chronic obstructive pulmonary disease (COPD) will be included.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11.1
    E.1.2Level LLT
    E.1.2Classification code 10009033
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of inhaled aclidinium bromide 400 μg BID in moderate to severe COPD patients.
    • To assess the safety and tolerability of multiple doses of inhaled aclidinium bromide 400 μg BID in the same target population.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and non-pregnant, non-lactating females aged ≥ 40. Women of childbearing potential are allowed to enter the trial ONLY if they use one medically approved (i.e., mechanical or pharmacological) contraceptive measure. A female is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year post-menopausal or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at the screening
    visit. For those females of childbearing potential who are unwilling to use contraceptive measures, they must provide a signed statement ensuring that they will not get pregnant throughout the study.
    2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines:
    (http://www.goldcopd.com) and stable airway obstruction.
    3. Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value (i.e., 30% ≤ 100xobserved post-salbutamol FEV1/ predicted FEV1 <80%) FEV1 at screening visit will be measured between 10-15 min post inhalation of 400 μg of salbutamol. Predicted normal values to be used for calculation purposes are to be based on
    European Community for Steel and Coal predicted values.
    4. Post-salbutamol FEV1/FVC < 70% at screening visit (i.e,. 100xpost-salbutamol FEV1/FVC < 70%).
    5. Current, or ex-cigarette smokers with a smoking history of at least 10 pack-years.
    Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has
    smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarettes per day/20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-years history).
    Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion as well.
    6. Patients whose COPD symptoms and FEV1 values at the time of randomisation are stable
    compared to the Screening visit, according to the investigator’s medical judgment.
    7. Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.
    E.4Principal exclusion criteria
    1. History or current diagnosis of asthma.
    2. A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks prior to the screening visit. Patients who develop a respiratory tract infection or exacerbation during the screening period will be discontinued from the trial prior to randomisation.
    3. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to
    screening visit.
    4. Use of long-term oxygen therapy (≥ 15 hours/day).
    5. Patients with a body mass index (BMI) ≥ 40 kg/ m2.
    6. Patients who have a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.
    7. Clinically significant respiratory conditions defined as but not limited to:
    • Known active tuberculosis.
    • History of interstitial lung or pulmonary thromboembolic disease.
    • Pulmonary resection during the past 12 months.
    • History of life-threatening COPD.
    • History of any bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc).
    • Patients who in the investigator’s opinion may need pulmonary rehabilitation or a thoracotomy during the trial. Patients on a stable pulmonary rehabilitation program prior to entry and anticipated to be stable throughout the study can be enrolled.
    • Lung cancer
    8. Clinically significant cardiovascular conditions defined as but not limited to:
    • Myocardial infarction during the last 6 months.
    • Unstable arrhythmia which has required changes in the pharmacological therapy or other intervention during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months.
    • Hospitalisation within the previous 12 months for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association.
    • Thoracic surgery within the previous 24 months.
    9. Patients for whom the use of anticholinergic drugs is contraindicated:
    - Patients with a known symptomatic prostatic hypertrophy and/or bladder neck obstruction.
    Patients with a diagnosis of these conditions but without symptoms due to stable concomitant medication for its treatment are allowed to enter trial.
    - Patients with narrow-angle glaucoma.
    10. Patients with any other serious or uncontrolled physical or mental dysfunction which at the discretion of the investigator could place the patient at higher risk derived from his/her participation in the study, could confound the results of the trial, or is likely to prevent the patient from complying with the requirements of the trial or completing the trial period.
    11. QTc [calculated according to Bazett’s formula (QTc=QT/RR1/2) above 470 milliseconds in the ECGs performed at screening visit.
    12. Patients who can not perform repeatable spirometry attempts at the screening visit (as stated in section 11.3.2.1 of the protocol).
    13. History of untoward reactions to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
    14. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
    15. Clinically relevant abnormalities laboratory, ECG parameters (other than QTc), or physical examination results at the screening evaluation that in the investigator’s opinion, preclude study participation.
    16. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication (see section 10.3.2 of the protocol).
    17. Patients with a history of drug and/or alcohol abuse or addiction during the previous 2 years that may prevent compliance with trial activities.
    18. Treatment with any Investigational Medicinal Product (IMP) within 1 month prior to the screening visit or the equivalent time of 6 half-lives of the IMP, whichever is longer.
    19. Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., history of sleep apnoea syndrome, any disease related with sleep disturbances such as restless-legs syndrome or somnambulism…). Moreover, night shift workers will be excluded.
    20. Patients who have participated in other studies involving aclidinium bromide.
    21. Vulnerable subjects (e.g. persons kept in detention).
    22. Patients who are unlikely to be co-operative, take their medication, complete their patient diary or attend the clinic at the required times.
    E.5 End points
    E.5.1Primary end point(s)
    Primary variable:
    Change from baseline in normalised FEV1 area under the curve over the 12-h period immediately after morning IMP administration, AUC0-12, at Day 15 on treatment

    The secondary efficacy variables will be the following:
    1) Change from baseline in normalised FEV1 AUC0-12 at Day 1 on treatment
    2) Change from baseline in normalised FVC AUC0-12 at Days 1 and 15 on treatment
    3) Change from baseline in normalised FEV1 AUC0-24at Days 1 and 15 on treatment
    4) Change from baseline in normalised FVC AUC0-24 at Days 1 and 15 on treatment
    5) Change from baseline in normalised FEV1 AUC12-24 at Days 1 and 15 on treatment
    6) Change from baseline in normalised FVC AUC12-24 at Days 1 and 15 on treatment
    7) Change from baseline in morning pre-dose FEV1 at Days 1 and 15 on treatment
    8) Change from baseline in morning pre-dose FVC at Days 1 and 15 on treatment
    9) Change from baseline in evening pre-dose FEV1 at Days 1 and 15 on treatment
    10) Change from baseline in evening pre-dose FVC at Days 1 and 15 on treatment
    11) Change from baseline in FEV1 after 23 and 24 hours of morning dosing at Day 15 on treatment
    12) Change from baseline in FVC after 23 and 24 hours of morning dosing at Day 15 on treatment
    13) Change from baseline in morning peak FEV1 at Days 1 and 15 on treatment
    14) Change from baseline in morning peak FVC at Days 1 and 15 om treatment
    15) Change from baseline in evening peak FEV1 at Days 1 and 15 on treatment
    16) Change from baseline in evening peak FVC at Days 1 and 15 on treatment
    17) Change from baseline in FEV1 at each specific time-point at Days 1 and 15 on treatment
    18) Change from baseline in FVC at each specific time-point at Days 1 and 15 on treatment.
    19) Change from baseline in day and night use of relieve medication recorded by the patient (number of puffs) at Weeks 1 and 2 on treatment
    20) Change from baseline in COPD symptom scores at Weeks 1 and 2 on 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 Yes
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 Information not present in EudraCT
    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 end of the trial is defined as the last visit of the last patient.
    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 months5
    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 months5
    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.1.3Elderly (>=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 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.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)
    The patients will continue their habitual therapy.
    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 Decision2009-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-01
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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