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    Summary
    EudraCT Number:2006-006276-38
    Sponsor's Protocol Code Number:A4471008
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-02
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2006-006276-38
    A.3Full title of the trial
    A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18 MCG of Tiotropium inhalation capsules administered by Handihaler® once-daily plus PRN Albuterol (Salbutamol) vs. placebo plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease subjects naive to maintenance therapy.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA4471008
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorBoehringer-Ingelheim
    B.1.3.4CountryPortugal
    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 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 AuthorisationNetherlands
    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 nameSpiriva
    D.3.4Pharmaceutical form Capsule, hard
    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
    D.3.9.1CAS number 186691-13-4
    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 placeboCapsule, hard
    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
    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
    The primary objective will be to evaluate the difference between treatments with tiotropium plus prn albuterol (salbutamol) vs. placebo plus prn albuterol (salbutamol) on AUC(0-3h), FEV1 normalized over three hours.
    E.2.2Secondary objectives of the trial
    The effect of tiotropium treatment on other lung function variables and outcomes such as activity, symptoms and productivity will also be assessed as secondary objectives. The activity monitor outputs in this trial will be considered experimental in nature. The correlation between health related Quality of Life and activity will also be examined at baseline as an exploratory objective.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. All subjects must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
    2. All subjects must have a diagnosis of COPD according to GOLD guideline criteria: post-bronchodilator FEV1/FVC ratio < 70% (visit 1).
    3. Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1).
    4. Subjects must be male or female, 40-80 years of age.
    5. Subjects must be current or ex-smokers with a smoking history of >10 pack years.
    6. Subjects must have a Medical Research Council (MRC) dyspnea score > 2.
    7. Subjects must be able to demonstrate compliance with the HandiHaler® and an albuterol (salbutamol) MDI during the screening period.
    8. Subjects must be able to demonstrate compliance with the activity monitor during the screening period.
    9. Subjects must be able to perform acceptable PFTs and follow study procedures.
    10. Subjects must be able to perform an Exercise Stress Test.
    11. Subjects must be able to demonstrate a stabilized smoking status at least 1 month prior to visit 1.
    E.4Principal exclusion criteria
    1. Subjects who have been treated with maintenance medications for chronic respiratory disease (e.g. long acting β-agonists, inhaled anticholinergics, inhaled or systemic corticosteroids, theophylline, leukotriene receptor antagonists) within six months prior to screening.
    2. Subjects with significant diseases other than COPD. A significant disease is defined as a disease or condition, which, in the opinion of the investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject’s ability to participate in the study.
    3. Subjects who have ever had a diagnosis of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease documented by a physician.
    4. Subjects with a history of pulmonary resection.
    5. Subjects with a history of thoracotomy for other reasons should be evaluated as per Exclusion criteria 2.
    6. Subjects on chronic systemic corticosteroids.
    7. Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3.
    8. Subjects who exacerbate in the 6 weeks prior to screening can be re-screened after recovery from the exacerbation.
    9. Subjects who exacerbate during the screening period can be re-screened 6 weeks following recovery from the exacerbation.
    10. Subjects whose activity is significantly limited by non-pulmonary disease (i.e., arthritis). Subjects with a recent (past 6 months) myocardial infarction, any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
    11. Subjects who are known to have clinically significant laboratory and/or electrocardiogram abnormalities in the judgment of the Investigator.
    12. Subjects who have any contraindication to exercise or have abnormal exercise stress test results based on criteria established by the ACC/AHA 1997 and/or the ATS/ACCP 2003 and/or thought to be of clinical significance in the judgment of the investigator or his medical designee
    13. Subjects with a malignancy and who are currently undergoing radiation therapy or have had chemotherapy within 5 years.
    14. Subjects who are pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for at least three months prior to screening and for the duration of the trial.
    15. Subjects who are currently participating or have recently participated in another trial with investigational drug within 30 days or 6 half-lives of the investigational agent (whichever is greater) at the start of the study or who are currently participating in another interventional study.
    16. Subjects with a known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule or metered dose aerosol delivery systems.
    17. Subjects with a known nickel-cutaneous hypersensitivity (component of the activity monitor).
    18. Subjects who are currently or have ever been in a pulmonary rehabilitation program.
    19. Subjects who are currently or that have been in a cardiac rehabilitation program within 6 months prior to visit 1.
    20. Subjects with a history of significant alcohol or drug abuse.
    21. Subjects with known active tuberculosis
    22. Subjects with known narrow-angle glaucoma.
    23. Subjects with moderate or severe renal failure.
    24. Subjects with significant symptomatic prostatic hyperplasia or bladder-neck obstruction. (Subjects whose symptoms are controlled on treatment may be included.)
    25. Subjects with significant orthopedic, neurological, or musculoskeletal disease interfering with the ability to exercise.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the forced expiratory volume in 1 second (FEV1) AUC(0-3h) post-dose response at week 24 (end of study). Baseline is defined as the time point of pre-dose measurement at Week 0. Response is defined as the change from baseline to 3 hours post dose AUC0-3h FEV1 at the final visit (Week 24).
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Single blind run in phase of 3 weeks prior to study start
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 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
    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 months6
    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 months6
    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 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.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 436
    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)
    Subjects will receive either tiotropium or placebo during the study. Tiotropium will not be made available in the regim of the study after the study has ended.
    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 Decision2007-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-07-02
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