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    The EU Clinical Trials Register currently displays   38917   clinical trials with a EudraCT protocol, of which   6396   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2005-005101-39
    Sponsor's Protocol Code Number:M/34273/30
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-16
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-005101-39
    A.3Full title of the trial
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberM/34273/30
    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 SponsorAlmirall Prodesfarma, S.A.
    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.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.3.2Product 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.3.9.1CAS 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Maintenance treatment of patients with moderate to severe stable chronic obstructive pulmonary disorder.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the long term bronchodilator efficacy and benefit in terms of
    exacerbation control and disease-related health status and other secondary
    outcomes of LAS 34273 200 μg administered once daily by inhalation (via
    Novolizer®) for 52 weeks compared to placebo in patients with moderate to
    severe, stable chronic obstructive pulmonary disease (COPD).
    2. To evaluate the long term safety and tolerability of LAS 34273 200 μg
    administered once daily for 52 weeks by inhalation (via Novolizer®)
    compared to placebo in the same target population.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacodynamic steady state sub study 12 hour spirometry sub study Holter sub study The sub studies are detailed on page 5 of the protocol.
    E.3Principal inclusion criteria
    For inclusion and randomization in the trial, patients must meet each of the following 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 TWO 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 Visit 1.
    2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines:
    (http://www.goldcopd.com) and stable airway obstruction.
    3. Patients whose FEV1 at Visit 1 measured between 30-45 min post inhalation of 400 μg of salbutamol is <80% of the predicted normal value (i.e., 100xobserved post-salbutamol FEV1/predicted FEV1 <80%)
    Predicted normal values to be used for calculation purposes are to be based on European Community for Steel and Coal predicted values (Quanjer et al. 1993)
    4. Under the same above conditions, pre-dose FEV1 at Visit 2 needs to be within the range of 80-120% of the FEV1 measured at Visit 1 prior to salbutamol inhalation [i.e. within the interval: 0.8xpre-salbutamol FEV1 (Visit 1) – 1.2xpre-salbutamol FEV1 (Visit 1)]. FEV1 value in the formulae will be the mean FEV1 of the greatest FEV1 values obtained at the two timepoints measured at Visits 1 and 2.
    5. Post-salbutamol FEV1/FVC ≤70% at Visit 1 (i.e,. 100xpost-salbutamol FEV1/FVC ≤70%) and FEV1/FVC ≤70% at Visit 2 (Day 1).
    6. 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.
    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
    Patients randomised into the trial must not present any of the following conditions:
    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 Visit 1. Patients who develop a respiratory tract infection or exacerbation during the run-in 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 Visit 1.
    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), as indicated in the paper tracing generated by the equipment used to record the ECGs] above 470 milliseconds in any of the ECGs performed at Visit 1 or pre-dosing at Visit 2 (Day 1).
    11. Patients with a life expectancy of less than 1 year because of disease severity.
    12. Patients who do not demonstrate to perform reproducible spirometry attempts at Visit 1 and predosing at Visit 2 (Day 1) as stated in section 11.2.1.
    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 to perform spirometry and peak flow measurements.
    15. Clinically relevant abnormalities in the results of laboratory, ECG parameters, other than QTc, or physical examination at the screening evaluation (Visit 1) if the abnormality defines a disease state listed as an exclusion criterion, except for those related to COPD.
    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 10.5.1).
    17. Patients with a history of drug and/or alcohol abuse that may prevent compliance with trial activities.
    18. Patients who have participated in other studies involving LAS 34273.
    19. Treatment with any Investigational Medicinal Product (IMP) within 1 month prior to Visit 1 or the equivalent time to 6 half-lives of the IMP, whichever is longer.
    20. Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers will be excluded).
    21. Patients who are unlikely to be co-operative, take their medication, complete their Electronic and Paper Diaries or attend the clinic at the required times.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    Trough forced expiratory volume in one second (FEV1).
    Trough FEV1 is defined as the mean FEV1 value of the two greatest FEV1 readings measured at 23 and 24 hours after the administration of the investigational medicinal product (IMP). The primary timepoint will be trough FEV1 values at the end of the first 28 weeks of treatment.

    Secondary efficacy Endpoint:
    - Exacerbations:
    • Time to first exacerbation, rates of exacerbations, severity, associated treatment
    and need for hospitalisation will be assessed.
    • Resource utilisation, particularly associated with exacerbations will also be
    documented and average costs subsequently applied.
    - Health status / Quality of Life:
    • Saint George’s Respiratory Questionnaire (SGRQ): total and three dimension
    scores (symptoms, activity, impact)
    • EuroQol questionnaire (EQ-5D): weighted health state index and associated
    visual analogue scale (VAS)

    Safety Endpoints:
    • Adverse events (AEs)
    • Serious adverse events (SAEs)
    • Physical examination (including blood pressure)
    • Laboratory assessments (standard haematology, biochemistry and urinalysis)
    • 12-lead ECG tracing
    • 3-lead 24-h Holter monitoring (in a subgroup of patients, approximately 20% of
    the total sample, performed at selected centres)
    • Number of withdrawals due to AEs
    • Reasons for withdrawal.

    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 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 No
    E. 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 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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 patient last visit
    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 months8
    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 months8
    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) 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 Information not present in EudraCT
    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. of subjects incapable of giving consent
    women of childbearing potential using 2 medically approved contraception measures
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state144
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 532
    F.4.2.2In the whole clinical trial 820
    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 Decision2006-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-06
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