Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35513   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-003413-33
    Sponsor's Protocol Code Number:TBB-COPD-201
    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:2012-09-26
    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 number2012-003413-33
    A.3Full title of the trial
    A Randomized, Open-Label, Repeat Dosing (7 days), Four-Period Crossover Study to Compare the Pharmacokinetics, Efficacy and Safety of Tiotropium Bromide Delivered via Breath Actuated Inhaler (BAI), SPIRIVA® HandiHaler® and Respimat® Soft Mist™ Inhaler (SMI) in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing the pharmacokinetics (the way the body absorbs, distributes, and gets rid of a drug), effectiveness and safety of Tiotropium Bromide in three different types of inhalers (Breath Actuated Inhaler, SPIRIVA® HandiHaler®, Respimat® Soft Mist™ Inhaler) in subjects with Chronic Obstructive Pulmonary Disease (COPD)
    A.4.1Sponsor's protocol code numberTBB-COPD-201
    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 SponsorTeva Branded Pharmaceutical Products R&D, Inc.
    B.1.3.4CountryUnited States
    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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRS Clinical Research Services Mannheim GmbH
    B.5.2Functional name of contact pointClinical Studies Phase I/II
    B.5.3 Address:
    B.5.3.1Street AddressGrenadierstraße 1
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68167
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962115045255
    B.5.5Fax number+4962115045128
    B.5.6E-mailmelanie.haagen@crs-group.de
    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 nameTiotropium HFA Breath Actuated Inhaler 4.5 mcg/actuation
    D.3.2Product code Tiotropium HFA BAI
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    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 INNTIOTROPIUM BROMIDE
    D.3.9.1CAS number 136310-93-5
    D.3.9.2Current sponsor codeTBB
    D.3.9.3Other descriptive nameANHYDROUS TIOTROPIUM BROMIDE
    D.3.9.4EV Substance CodeSUB25692
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    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.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® 18 Mikrogramm Kapsel mit Inhalationspulver
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pharma GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 SPIRIVA® HandiHaler®
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNTIOTROPIUM BROMIDE
    D.3.9.1CAS number 411207-31-3
    D.3.9.3Other descriptive nameTIOTROPIUM BROMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21897
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    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 Yes
    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.IMP: 3
    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® Respimat® 2,5 Mikrogramm Lösung zur Inhalation
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pharma GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Spiriva® Respimat®
    D.3.4Pharmaceutical form Inhalation solution
    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 INNTIOTROPIUM BROMIDE
    D.3.9.1CAS number 411207-31-3
    D.3.9.3Other descriptive nameTIOTROPIUM BROMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21897
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.124
    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 Yes
    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
    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 (COPD)
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD)
    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 15.0
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 of this study is to assess and compare the pharmacokinetics (PK) of Tiotropium delivered via BAI (4.5 mcg or 9.0 mcg), SPIRIVA HandiHaler (18 mcg) and Respimat SMI (5.0 mcg) following repeat dosing for 7 days in subjects with COPD.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To evaluate the efficacy of Tiotropium HFA inhalation aerosol delivered via BAI (4.5 mcg or 9.0 mcg) compared with Tiotropium bromide delivered via SPIRIVA HandiHaler (18 mcg tiotropium) and Respimat SMI (5.0 mcg tiotropium) in subjects with COPD following repeat dosing for 7 days.
    • To evaluate the safety and tolerability of Tiotropium HFA BAI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent signed and dated by the subject before conducting any study related procedure
    2. Male or female subjects 40 -80 years of age, as of the Screening Visit
    3. Diagnosis of COPD as defined by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) Guidelines
    4. A pre-bronchodilator Peak Inspiratory Flow (PIF) rate≥ 30 L/ min as measured with the In-CheckTM DIAL training device.
    5. A measured post-bronchodilator (ipratropium bromide) FEV1 >30% and <80% of predicted normal for height, age and gender at the Screening Visit (SV). NHANES III predicted values will be used and adjustments to predicted values will be made for African-American subjects [1].
    6. A measured post-bronchodilator (ipratropium bromide) FEV1/FVC <0.70 at the Screening Visit (SV)
    7. If female, is currently not pregnant, breast feeding, or attempting to become pregnant (for 4 weeks before the Screening Visit (SV) and throughout the duration of the study), and is of
    • Non-childbearing potential, defined as:
    o ≥1 year post-menopausal or
    o Surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, or hysterectomy)
    or is of
    • Childbearing potential, has a negative serum pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:
    o Systemic contraception used for ≥1 month prior to screening, including birth control pills, transdermal patch, vaginal ring, implants, or injectables or
    o Double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide) or
    o Intrauterine device (IUD) with a low failure rate defined as <1% per year (use of copper IUDs are excluded)
    or is of
    • Childbearing potential and not sexually active, has a negative serum pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active
    8. Current or ex-smoker with ≥10 pack-year smoking history
    9. Subject is free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study
    10. Able to perform technically acceptable and reproducible spirometry per study guidelines as defined in the protocol and study procedures manual.
    11. Able to demonstrate the proper inhalation techniques required for correct use of all delivery devices required in the study
    12. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and being compliant with all study requirements
    E.4Principal exclusion criteria
    1 Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject’s last study related visit
    2 History or current evidence of a clinically significant or uncontrolled disease including, but not limited to: cardiovascular, hepatic, renal, haematological, neuropsychological, endocrine, gastrointestinal or pulmonary (other than COPD such as asthma, sarcoidosis, non-CF bronchiectasis , cystic fibrosis, bronchopulmonary dysplasia or a diagnosis of alpha 1-antitrypsin deficiency). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study
    3 History of and/or current diagnosis of asthma
    4 History of a life-threatening COPD exacerbation
    5Thoracotomy with pulmonary resection
    6 Current congestive heart failure, history or current evidence of myocardial infarction (within 3 yrs of the Screening Visit [SV]), or history or current evidence of ischemic heart disease, including a diagnosis on screening ECG
    7 History or current evidence of clinically significant cardiac arrhythmia, including a diagnosis on screening ECG
    8 Presence of angle-closure glaucoma
    9 History of malignancy (excluding basal cell carcinoma) within the past 5 years, regardless of the clinical significance or current stability of the disease
    10 Known history or any current evidence of renal impairment or urinary retention. This includes abnormal renal function test results at screening
    11 Presence of symptomatic prostatic hyperplasia
    12 History of silent infections, including positive tests for HIV1, HIV2, Hepatitis B, Hepatitis C, or tuberculosis
    13 Occurrence of any upper or lower respiratory infection, including but not limited to the common cold and flu, sinusitis, tonsillitis, pneumonia, bronchitis, or an ear infection (including otitis media and externa) which is not resolved by 14 days prior to randomization
    14 Occurrence of a COPD exacerbation which is not resolved by 14 days prior to randomization
    15 Subjects who require oxygen therapy and in the investigator’s opinion, will be unable to abstain from the use of oxygen therapy during testing
    16 Subjects who have started or stopped an exercise rehabilitation program within 4 weeks of SV
    17 Known or suspected hypersensitivity or idiosyncratic reaction to tiotropium, or to any ingredients used in the study medication formulations
    18 Severe allergy to milk protein
    19 Significant adverse drug reactions, including allergy or hypersensitivity reactions, to atropine or any anticholinergic substance related pharmacologically to atropine
    20 Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to SV
    21 Treatment with orally administered (excluding orally inhaled) β-adrenergics
    22 Treatment with β–adrenergic receptor antagonists administered by any route. The single exception is that cardioselective β1–adrenergic receptor antagonists are permitted provided that subjects have been on a stable dose for at least 1 week prior to SV and subjects are expected to be able to maintain the same dose throughout the study
    23 Treatment with drugs commonly recognized to prolong the QTc interval
    24 Treatment with any known CYP2D6 or CYP3A4 inhibitors within 30 days prior to SV
    25 Initiation or change in dose of inhaled corticosteroids within the last 6 weeks prior to the SV, and /or not expected to maintain a stable dose of inhaled corticosteroids during the course of the study
    26 Initiation or change in dose of oral or systemic corticosteroids within the last 6 weeks prior to the SV, unable to maintain a stable dose of oral or systemic corticosteroids during the course of the study, or a dose of oral or systemic corticosteroids in excess of the equivalent of 10 mg of prednisone per day
    27 Exposure to any investigational drug within 30 days or six half-lives (whichever is greater) prior to SV
    28 Plans to donate or has donated plasma or blood within 1 month prior to SV. This does not include small blood volumes taken for diagnostic purposes. Plans to donate plasma or blood within 3 months following study completion
    29 Has a history of alcohol and/or substance abuse within the past 5yrs
    30 Vulnerable subjects (e.g. persons kept in detention)
    31The subject is an employee of the study site or has an immediate family member or household member involved with the conduct of the study (including participation in the study)
    E.5 End points
    E.5.1Primary end point(s)
    Primary Pharmacokinetic Outcome Measures (on Day 7 following 7 days of repeat dosing):
    • Area under the plasma concentration-time curve on day 7 from time 0 to 24 hours (AUC0-24) for tiotropium
    • Maximum observed plasma concentration (Cmax) for tiotropium
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7-Day 8, following 7 days repeat dosing
    E.5.2Secondary end point(s)
    Secondary Pharmacokinetic Outcome Measure (on Day 7 following 7 days of repeat dosing):
    • Area under the plasma concentration-time curve on day 7 from time 0 to the time of the last quantifiable concentration as measured up to 24 hrs (AUC 0-t) for tiotropium
    • Time at which the maximum plasma concentration was observed (tmax)for tiotropium

    Other Pharmacokinetic Outcomes:
    • The cumulative amount of urinary excretion of tiotropium, over 24 hours post-dose on Day 7.
    • The plasma and urine levels of tiotropium on Day 1, at the start of each dosing period/end of each washout period

    Efficacy
    The following efficacy endpoints will be assessed on Day 8 (23-24 hours post-dosing on day 7) of each Treatment Period:
    • Trough FEV1, defined as the average of the values at 23-24 hours post-Day 7 dose
    • Trough FVC, defined as the average of the values at 23-24 hours post-Day 7 dose

    The following efficacy endpoints will be assessed on Day 7 of each Treatment Period:
    • Time to onset of measured effect (>10% improvement in FEV1 from pre-dose baseline on Day 7)
    • Time to peak FEV1
    • Forced expiratory volume in one second (FEV1) area under the curve for the time period 0 to 24 hours post-dose (FEV1 AUC(0-24h))
    • Forced Vital Capacity (FVC) AUC(0-24h)
    • Peak FEV1
    • Peak FVC

    The following efficacy-related endpoints will be assessed: Rescue medication use within 24 hours prior to study visit assessments and throughout the assessment period on Days 1 and 7 of each Treatment Period.

    Safety and Tolerability
    The following endpoints will be measured / recorded to evaluate safety and tolerability.
    • Serial FEV1 measures during 60 minutes post-dose on Day 1 of each Treatment Period (to assess paradoxical bronchoconstriction)
    • Rescue medication use during 60 minutes post-dose on Day 1 to use in assessing paradoxical bronchoconstriction.
    • Treatment-emergent adverse events throughout the study
    At times defined in the study schedule of events:
    • Vital signs (blood pressure and pulse rate)
    • Safety laboratory assessments
    • ECGs
    • Physical examinations
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Pharmacokinetic: Day 7, following 7 days repeat dosing

    Other Pharmacokinetic: Day 7

    Efficacy: Day 8 (23-24 hours post-dosing on day 7) of each Treatment Period OR Day 7, as detailed above



    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, intra-subject variability
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Repeat dosing
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 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
    LPLS
    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
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state32
    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)
    As patients of COPD, ensure participants have doctor providing adequate and appropriate ongoing treatment.


    NB No restrictions have been set regarding the percent of the population in the adult and elderly categories; there will be a total of 32 patients, ranging from 40 - 80 years of age.
    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 Decision2012-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-04
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA