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    Summary
    EudraCT Number:2005-005804-17
    Sponsor's Protocol Code Number:M/34273/24
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-11-02
    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 number2005-005804-17
    A.3Full title of the trial
    A Single Dose, Double-Blind, Double-Dummy, 3 Period Cross-Over, Placebo Controlled Clinical Trial To Assess the Rate of Onset of Action of Inhaled LAS 34273 200µg Compared To Placebo and Tiotropium 18µg in Patients with Chronic Obstructive Pulmonary Disease (COPD).
    A.4.1Sponsor's protocol code numberM/34273/24
    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 LAS 34273
    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 codeLAS-34273
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 AuthorisationSpain
    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
    Phase III placebo controlled crossover trial to better characterise the acute effect of LAS 34273 on bronchodilation action in severe COPD patients.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the rate of onset of bronchodilator action of inhaled LAS 34273 compared to placebo.
    E.2.2Secondary objectives of the trial
    To assess the rate of onset of action of inhaled LAS 34273 compared to tiotropium 18 µg and to placebo.
    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 measures. A female is considered to be of childbearing potential unless she has had an 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 screening visit.
    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 or greater than 30% of the predicted value and less than 60% of the predicted value (i.e., 30% ≤ 100xobserved post-salbutamol FEV1/ predicted FEV1 <60%) FEV1 at screening visit will be measured between 30-45 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 (13).
    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 packs-year.
    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-year history).
    Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion as well.
    6. 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, allergic rhinitis or atopy
    2. Eosinophil count > 600 cells/mm3.
    3. A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks prior to screening visit. Patients who develop a respiratory tract infection or exacerbation during the screening period will be discontinued from the trial prior to randomisation.
    4. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
    5. Use of long-term oxygen therapy (≥ 15 hours/day).
    6. Clinically significant respiratory conditions defined as:
    • 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 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.
    7. Clinically significant cardiovascular conditions defined as:
    • 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.
    8. Patients in whom the use of anticholinergic drugs is contraindicated: those with a known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
    9. Patients with any other serious or uncontrolled physical or mental dysfunction at the discretion of the investigator which could place the patient at higher risk derived from his/her participation into 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.
    10. QTc [calculated according to Bazett’s formulae (QTc=QT/RR1/2) above 470 milliseconds in the ECG performed at screening visit.
    11. Patients who do not demonstrate to perform reproducible spirometry attempts at screening visit.
    12. History of untoward reactions to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
    13. Patients unable to properly use a dry powder or pMDI inhaler device or to perform spirometry.
    14. Clinically relevant abnormalities in the results of laboratory, ECG parameters, other than QTc, or physical examination at the screening evaluation if the abnormality defines a disease state listed as an exclusion criterion, except for those related to COPD.
    15. 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.
    16. Patients with a history of drug and/or alcohol abuse that may prevent compliance with trial activities.
    17. Patients who have participated in other studies involving LAS 34273.
    18. Treatment with any Investigational Medicinal Product (IMP) within 1 month prior to screening visit or the equivalent time to 6 half-lives of the IMP, whichever is longer.
    Any further issues regarding the eligibility of a particular patient for entry into the trial should be discussed between the investigator and the Sponsor or its representatives and should be documented accordingly.
    E.5 End points
    E.5.1Primary end point(s)
    Primary variable:
    - Percentage of patients achieving a FEV1 increase from baseline equal to or greater
    than 10% at 30 min.

    Main secondary variables:
    - Normalised FEV1 AUC0-3 h.
    - Change from baseline in FEV1 at 30 min.

    Additional variables:
    - Percentage of patients achieving a FEV1 increase from baseline equal to or greater
    than 10% at other timepoints.
    - Percentage of patients achieving a FEV1 increase from baseline equal to or greater
    than 12% and 15% at all timepoints.
    - Change from baseline in FEV1 at other timepoints.
    - Change from baseline in FVC, FEF25-75% and IC at all timepoints.
    - Maximal changes from baseline in FEV1, FVC, FEF25-75% and IC.
    - Time to maximal change in FEV1, FVC, FEF25-75% and IC.
    - Normalised AUC0-30min and AUC0-1 h of FEV1, FVC and FEF25-75%, normalised AUC0-3 h of IC.
    - Change from baseline in perception of dyspnoea assessed with a visual analogue
    scale (VAS) at all timepoints.

    Safety Assessments
    - All adverse events.
    - All serious adverse events.
    - Physical examination (including blood pressure).
    - Laboratory assessments (standard haematology, biochemistry and urinalysis).
    - 12-lead ECG parameters.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.6Cross over Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Last patient last visit
    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 months6
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-11-02. Yes
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 108
    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)
    Normal treatment of the condition
    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 Decision2006-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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